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'''Title''': ''What standards and regulations affect a food and beverage laboratory?''
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| text      = This is sublevel4 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p>
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'''Author for citation''': Shawn E. Douglas
==Sandbox begins below==


'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
[[File:Lion Lab Technician2 (16279873861).jpg|right|400px]]This buyer's guide is based off the [[LIMS Buyer's Guide]], a former publication of the [[LabLynx, Inc.#Community history|Laboratory Informatics Institute]] (LII), an open trade association that was associated with [[LabLynx, Inc.]]<ref name="LII">{{cite web |url=http://www.limsfinder.com/BlogDetail.aspx?id=31049_0_3_0_C |archiveurl=https://web.archive.org/web/20130924062254/http://www.limsfinder.com/BlogDetail.aspx?id=31049_0_3_0_C |title=Laboratory Informatics Institute Established |publisher=Laboratory Informatics Institute, Inc |date=17 July 2006 |archivedate=24 September 2013 |accessdate=31 January 2023}}</ref><ref name="LBGOrig">{{cite web |url=http://limsbook.com/ |archiveurl=https://web.archive.org/web/20130602164430/https://www.limsbook.com/ |title=The LIMSbook ...everything about LIMS |publisher=Laboratory Informatics Institute, Inc |archivedate=02 Junw 2013 |accessdate=31 January 2023}}</ref> In late 2013, the LII and LabLynx discontinued publishing a copyrighted version and chose to release future guides to the public domain via this wiki. Per the [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons license] and the [[LIMSWiki:Copyrights|copyright terms of this site]], you are free to copy, adapt, distribute, and transmit this guide as long as you 1. give proper attribution and 2. distribute the work only under the same or a similar license.


'''Publication date''':


==Introduction==
==1. Introduction==
Societies around the world have grown to expect and depend on high-quality, nutritious foods and beverages, whether coming directly from a farm or being produced by a food and beverage manufacturer. With the history of food and beverage safety having a [[LIMS FAQ:What is the importance of a food and beverage testing laboratory to society?#History of food and beverage testing and regulation|somewhat checkered past]] until the early twentieth century, this expectation hasn't always been easy to meet. However, with better understanding of food safety and greater efforts to standardize and regulate it, governments and producers have improved food quality and safety into the twenty-first century. Yet any assurances coming from these efforts to standardize and regulate are dependent upon rigorous and validated methods not only in the production facility but also in any [[laboratory]] making analyses for the facility.  
What exactly is a [[laboratory information management system]] (LIMS) or [[laboratory information system]] (LIS) anyway? Do I need one? What options are available and how do I compare them? Where does a user requirements specification (USR), [[request for information]] (RFI), request for proposal (RFP), or request for quotation (RFQ) come into play, and how does it fit into acquiring a [[laboratory informatics]] solution? These are questions [[laboratory]] professionals typically ponder upon finding themselves charged with the mission of finding software for their lab. It can be a daunting
proposition, and there are few at least partially objective references to help with it all. This brief guide exists to, in part, meet that need.


This topical article will briefly examine the standards, regulations, guidance, and other factors globally driven by not only the demand for safer foods and beverages, but also that in many cases dictate what and how quality activities are conducted towards ensuring food safety around the world inside and outside the food and beverage laboratory.
At the core of this buyer's guide are several elements, including core information about evaluating, acquiring, and implementing laboratory software that fits your lab's needs. Also included here are laboratory informatics vendors who actually make their pricing partially or fully public, through one means or another. That pricing may be fully transparent and posted on the company website, or it may be a partial representation of the lowest possible price offered, as with those vendors who have a publicly viewable contract with the U.S. General Services Administration. While in the past vendors have refrained from providing public pricing, a more open information process may have its merits (particularly for potential buyers), though also not without its own set of caveats.<ref name="OOaLOpen">{{cite web |url=http://outonalims.com/2011/08/15/understanding-openness-and-other-marketing-tactics-in-laboratory-informatics-and-other-industries/ |title=Understanding Openness and Other Marketing Tactics in Laboratory Informatics and Other Industries |author=Metrick, Gloria |publisher=GeoMetrick Enterprises |date=15 August 2011 |accessdate=06 September 2013}}{{Dead link |fix-attempted=yes}}</ref> The theory—at least on paper—has been that prices should decrease as LIMS become commodities that labs can compare and contrast in a more competitive fashion. However, it remains to be seen if that will ever be the case.


Laboratories are, by their very nature, in the business of producing analytical data and reports, essentially [[information]].<ref name="IFlowJourn">{{cite journal |journal=Administrative Science Quarterly |year=1969 |volume=14 |issue=1 |pages=12–19 |title=Information Flow in Research and Development Laboratories |author=Allen, Thomas J.; Cohen, Stephen I. |url=http://www.jstor.org/stable/2391357 |doi=10.2307/2391357}}</ref> Everything else that occurs in the laboratory is largely just a means towards that central goal of producing timely, accurate, and unbiased information. As such, in a very real sense, [[information management]] is, by extension, also at the core of any lab. In a world where we use the latest technology for most of our daily tasks and pleasures, why do so many labs still rely on hand-written notes and spreadsheets? Why do they still spend thousands of dollars on a sophisticated analytical instrument yet hesitate when faced with purchasing an information management system? The primary reason has traditionally been the cost associated with acquiring an informatics solution, as well as not having the information technology resources to properly implement it.<ref name="CHCFELINCS14">{{cite web |url=https://www.chcf.org/project/elincs-the-national-lab-data-standard-for-electronic-health-records/ |title=ELINCS: The National Lab Data Standard for Electronic Health Records |author=California Health Care Foundation |date=19 March 2014 |accessdate=31 January 2023}}</ref><ref name="JapsenDespite14">{{cite web |url=https://www.forbes.com/sites/brucejapsen/2014/03/29/despite-stimulus-dollars-hundreds-of-hospitals-still-use-mostly-paper-records/?sh=25c7b0364c19 |title=Despite Stimulus Dollars, Hundreds Of Hospitals Still Use Mostly Paper Records |author=Japsen, B. |work=Forbes |date=29 March 2014 |accessdate=31 January 2023}}</ref><ref name="ColangeliSILAB19">{{Cite journal |last=Colangeli |first=Patrizia |last2=Del Negro |first2=Ercole |last3=Molini |first3=Umberto |last4=Malizia |first4=Sara |last5=Scacchia |first5=Massimo |date=2019-12-01 |title=“SILAB for Africa”: An Innovative Information System Supporting the Veterinary African Laboratories |url=https://www.liebertpub.com/doi/10.1089/tmj.2018.0208 |journal=Telemedicine and e-Health |language=en |volume=25 |issue=12 |pages=1216–1224 |doi=10.1089/tmj.2018.0208 |issn=1530-5627}}</ref>


==Globally recognized food safety standards==
Software solutions like LIMS are increasingly becoming commodities, and potential buyers don't need to find the acquisition process as daunting as it used to be. As technology has improved, smaller LIMS companies have emerged, along with affordable [[Cloud computing|cloud-based]] [[software as a service|SaaS]] options that are flexible and reliable. This means any lab can put their resources where they belong: into its analytical information and its management.
Like other industries, the food and beverage industry depends on well-defined and -justified standards to better ensure the quality of their products. Implementing and maintaining conformance to internationally recognized and benchmarked food safety standards benefits the food and beverage organization in a number of ways<ref name="PavlovićWhat17">{{cite web |url=https://www.ideagen.com/thought-leadership/blog/what-is-brc-global-food-safety-standard-explained |title=What is BRC? Global food safety standard explained |author=Pavlović, A. |work=Ideagen Blog |publisher=Ideagen Limited |date=26 June 2017 |accessdate=10 November 2022}}</ref><ref name="PJBRCGS20">{{cite web |url=https://www.pjfsc.com/Downloads/BRC-Overview.pdf |format=PDF |title=BRCGS - British Retail Consortium Global Standard |publisher=Perry Johnson Food Safety Consulting, Inc |date=April 2020 |accessdate=10  November 2022}}</ref>:


*It increases customer confidence through the organization's audited certification to the standard, taking the place of customers' own auditing methods to ensure quality and authenticity, in turn reducing time and costs.
This brief buyer's guide is here to help you take the first steps towards acquiring a laboratory informatics solution. Use these vendor profiles and recommendations to get a feel for what's out there and what makes the most sense. This guide contains information on a little bit of everything, from discovering what a LIMS is to maintaining and supporting that system. While the LIMS is the stand-out solution among the crowd for laboratories, this guide may also reference other systems like a LIS or [[electronic laboratory notebook]] (ELN).  
*It drives organizations to better monitor their activities for non-conformities, identify root causes, and develop preventative controls, while clearly reporting such efforts to customers, further reducing the need for customer audits.
*It better ensures a rigorous and comprehensive approach to product safety, quality, integrity, and legality, in many cases meeting or exceeding local, state, federal, and/or international legislative requirements.
*It drives organizations to better vet their suppliers and service providers for meeting required food safety management practices.
*It enables organizations to better demonstrate auditable compliance with modern food safety management practices.
*It allows organizations to limit product recalls, reduce customer complaints, and better protect their brand.


As such, food and beverage researchers and manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to the food, beverage, and feed industries.


===British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)===
==2. How does laboratory software benefit the lab?==
In 1998, the [[wikipedia:British Retail Consortium|British Retail Consortium]] (BRD) published the first edition of its Global Standard for Food Safety (GSFS), going on to become an internationally recognized standard of best practices in food manufacturing, storage, and distribution, and the first food safety standard to be recognized by the Global Food Safety Initiative (GFSI; discussed later). The standard covers stakeholder buy-in on continual improvement, food safety plan development, food quality management system development, manufacturing and storage site standardization, product and process control, personnel management, risk management, and trade product management.<ref name="PavlovićWhat17" /><ref name="PJBRCGS20" /><ref name="EagleFood19">{{cite web |url=https://vertassets.blob.core.windows.net/download/45fe7af4/45fe7af4-0500-4163-bd2b-5dd34e824bfd/eagle_wp_food_safetyquality_regulations_guide_a4_en.pdf |format=PDF |title=Food Safety and Quality Regulations: A Guide to Global Standards |publisher=Eagle Product Inspection |date=May 2019 |accessdate=10 November 2022}}</ref><ref name="BRCGSFS8_18">{{cite web |url=https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf |format=PDF |title=Global Standard Food Safety |author=British Retail Consortium |publisher=British Retail Consortium |date=August 2018 |accessdate=10 November 2022}}</ref> The standard is implemented by an organization through gap assessment, documentation development, consultation and assessment, internal auditing, and resolving non-conformances to the standard.<ref name="PJBRCGS20" />  
Laboratory, scientific, and healthcare informatics solutions can improve laboratory [[workflow]]s while enhancing safety, quality, and compliance in a number of ways. A LIMS, for example, is often adopted to eliminate manual processes, improve sample management, increase productivity, and improve regulatory conformance.<ref name="Astrix2020LIMS">{{cite web |url=https://astrixinc.com/wp-content/uploads/2021/03/Astrix-2020-LIMS-Market-Research-Report.pdf |format=PDF |title=Astrix 2020 LIMS Market Research Survey Report |publisher=Astrix Technology, LLC |date=March 2021 |accessdate=01 February 2023}}</ref> The adoption of LIMS and other such systems to eliminate deficiencies and improve operations is often based in the disadvantages of paper-based processes—particularly in regulatory environments—and their inability at making their contents rapidly findable, searchable, modifiable, and secure.<ref name="LiscouskiLabTech20">{{cite web |url=https://www.limswiki.org/index.php/LII:Laboratory_Technology_Planning_and_Management:_The_Practice_of_Laboratory_Systems_Engineering |title=Laboratory Technology Planning and Management: The Practice of Laboratory Systems Engineering |author=Liscouski, J. |work=LIMSwiki |date=December 2020 |accessdate=01 February 2023}}</ref><ref name="LiscouskiTheApp21">{{cite web |url=https://www.limswiki.org/index.php/LII:The_Application_of_Informatics_to_Scientific_Work:_Laboratory_Informatics_for_Newbies |title=The Application of Informatics to Scientific Work: Laboratory Informatics for Newbies |author=Liscouski, J. |work=LIMSwiki |date=April 2021 |accessdate=01 February 2023}}</ref>


===Codex Alimentarius===
Even a fragmented mix of paper-based and electronic information sources can be a detriment to the traceability of or rapid accessibility to quality control samples, standard operating procedures (SOPs), calibration data, chain of custody data, and other vital aspects of analytical, sampling, and calibration testing in the lab. A well-implemented LIMS can reduce the silos of data and information, while at the same time make that information and data more secure and readily accessible. Given the demands placed on laboratories—by [[ISO/IEC 17025]] and clients seeking labs certified to that standard, for example—to provide rapid proof of traceable sample movement and relevant quality control data, integrating a LIMS into the laboratory makes sense. The LIMS can act as the central integrator and audit trail for all that laboratory data and information.<ref name="SmithInteg19">{{cite web |url=https://foodsafetytech.com/feature_article/integrated-informatics-optimizing-food-quality-and-safety-by-building-regulatory-compliance-into-the-supply-chain/ |title=Integrated Informatics: Optimizing Food Quality and Safety by Building Regulatory Compliance into the Supply Chain |author=Smith, K. |work=Food Safety Tech |date=02 July 2019 |accessdate=20 January 2023}}</ref><ref name="McDermottHowDig18">{{cite web |url=https://foodsafetytech.com/column/how-digital-solutions-support-supply-chain-transparency-and-traceability/ |title=How Digital Solutions Support Supply Chain Transparency and Traceability |author=McDermott, P. |work=Food Safety Tech |date=31 July 2018 |accessdate=20 January 2023}}</ref><ref name="EvansTheDig19">{{cite web |url=https://foodsafetytech.com/feature_article/the-digital-transformation-of-global-food-security/ |title=The Digital Transformation of Global Food Security |author=Evans, K. |work=Food Safety Tech |date=15 November 2019 |accessdate=20 January 2023}}</ref> Because the LIMS improves traceability—including through its automated interfaces with instruments and other data systems—real-time monitoring of supply chain issues, quality control data, instrument use, and more is further enabled, particularly when paired with configurable dashboards and alert mechanisms. By extension, labs can more rapidly act on insights gained from those real-time dashboards.<ref name="SmithInteg19" />  
The [[wikipedia:Codex Alimentarius|Codex Alimentarius]] is a collection of internationally recognized food and feed standards and guidelines developed as a joint venture between the United Nation's Food and Agricultural Organization (FAO) and the [[World Health Organization]] (WHO).<ref name="EagleFood19" /> The Codex "is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade."<ref name="FAOCodexAbout">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/about-codex/en/#c453333 |title=About Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=10 November 2022}}</ref> Scope of the standards is broad, covering food hygiene; food additives and contaminants, including pesticides and drugs; packaging and labelling; sampling and analysis methods; and import and export inspection and certification.<ref name="FAOCodexAbout" /> It's not unusual for governments to approach the FAO seeking help with harmonizing national legal frameworks of food safety with the Codex Alimentarius.<ref name="FOAFood22">{{cite web |url=https://www.fao.org/food-safety/food-control-systems/policy-and-legal-frameworks/food-laws-and-regulations/en/ |title=Food laws & regulations |publisher=Food and Agricultural Organization |date=2022 |accessdate=10 November 2022}}</ref> Among the Codex, some of the more broadly useful standards include General Principles of Food Hygiene (CXC 1-1969)<ref name="FAOCodes22">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/codex-texts/codes-of-practice/en/ |title=Codes of Practice |work=Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=10 November 2022}}</ref>, General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995), and General Methods of Analysis for Contaminants (CXS 228-2001).<ref name="FAOContam22">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/thematic-areas/contaminants/en/ |title=Contaminants |work=Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=10 November 2022}}</ref>


===Global Food Safety Initiative (GFSI)===
There is a growing variety of laboratory informatics software providing these and other benefits to labs, allowing them to more rapidly adapt and remain competitive. Arguably, the most common solutions are the LIMS and LIS. The LIMS and LIS are similar, in that they focus on the entire laboratory process and improving the various aspects of it. Traditionally, the LIMS has been used in more non-clinical environments and the LIS in more clinical environments, but that distinction has been fading for well over a decade. These distinctions have blurred even more with the age of modular and platformed software solutions that are able to adapt to most any industry. For now, just know that these systems are a bit more holistic, placing the focus on improving your lab's workflows, which in turn strengthens traceability, analytical outcomes, and—in the case of clinical settings—patient outcomes. Outside of that, there are other more specialized solutions, including:
The [[wikipedia:Global Food Safety Initiative|GFSI]] is a collection of private organizations that has developed a set of benchmarking requirements for improving food safety management programs, with a goal of making them balanced enough to be broadly applicable while remaining relevant to different countries and regions of the world.<ref name="EagleFood19" /> Previously known as the GFSI Guidance Document<ref name="GFSIRelease17">{{cite web |url=https://mygfsi.com/press_releases/gfsi-releases-new-edition-of-benchmarking-requirements/ |title=GFSI Releases New Edition of Benchmarking Requirements |publisher=Global Food Safety Initiative |date=28 February 2017 |accessdate=10 November 2022}}</ref>, the GFSI Benchmarking Requirements act as a set of criteria and professional framework for food safety management programs to fulfill, formally allowing an organization to be recognized and certified by the GFSI. Certification to the GFSI Benchmarking Requirements "demonstrates an organization’s serious commitment to food safety to customers and potential customers across the world."<ref name="EagleFood19" /> An organization seeks out a third-party certification program owner (CPO) and undergoes the auditing process, which is driven and supported by the GFSI Benchmarking Requirements.<ref name="GFSICert22">{{cite web |url=https://mygfsi.com/how-to-implement/certification/ |title=Certification |publisher=Global Food Safety Initiative |date=2022 |accessdate=10 November 2022}}</ref> GFSI is also responsible for ensuring CPOs and certification bodies meet the necessary requirements.


===Hazard analysis and critical control points (HACCP)===
* the ELN, which is used in many research and development environments (among others) as a means to securely and collaboratively document experiments and their results;
The [[wikipedia:Hazard analysis and critical control points|hazard analysis and critical control points]] or HACCP system has been adopted and integrated in various ways over the years<ref name="WeinrothHist18">{{Cite journal |last=Weinroth |first=Margaret D |last2=Belk |first2=Aeriel D |last3=Belk |first3=Keith E |date=2018-11-09 |title=History, development, and current status of food safety systems worldwide |url=https://academic.oup.com/af/article/8/4/9/5087923 |journal=Animal Frontiers |language=en |volume=8 |issue=4 |pages=9–15 |doi=10.1093/af/vfy016 |issn=2160-6056 |pmc=PMC6951898 |pmid=32002225}}</ref>, but at its core, the system directs organizations to focus on key areas or "critical control points" (CCPs) of vulnerability and hazard within the production process and mitigate their impact on overall food safety.<ref name="EagleFood19" /> Though the seeds of HACCP go back to the 1970s, it wasn't until the mid-1990s that it began finding its way into formal regulatory structures in the United States, first codified as 9 CFR Parts 304, 308, 310, 320, 327, 381, 416, and 417 in July 1996.<ref name="WeinrothHist18" /><ref name="61FR38806">{{cite web |url=https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary |title=61 FR 38806 - Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems |work=Federal Register |publisher=U.S. Government Publishing Office |date=25 July 1996 |accessdate=10 November 2022}}</ref> HACCP also found its way into other standards benchmarked by the GFSI.<ref name="WeinrothHist18" /> The concept of HACCP has perhaps changed slightly over the years, but the main principles remain<ref name="EagleFood19" />:
* the [[laboratory execution system]] (LES), which is used in production-based environments to ensure the rigidity of a method and and the process' end result;
* the [[chromatography data system]] (CDS), which is used to accurately collect, process, and visualize [[chromatography]] data; and
* the [[scientific data management system]] (SDMS), which is used to collect disparate silos of data and information across the laboratory enterprise and make it more actionable.}}


#Conduct a hazard analysis.
While these systems can be found in many types of labs, some tendencies appear. LIMS, LIS, and ELN are top-level solutions that help the lab manage workflows, as well as aggregate and organize data and information, including analytical- and experiment-based results. In services labs, the ELN is less likely to appear. However, in the case of research labs, the ELN may function more top-level, with the LIMS acting as a supplementary system for managing test workflows before associated test results are loaded into the ELN. Support systems like the LES, CDS, and SDMS may also appear, filling specialized roles. The LES will appear in more regulated environments where laboratory procedures must be executed precisely, before then feeding results to a LIMS or ELN. The CDS will appear in labs doing heavy chromatography work, and it too may feed data into a LIMS or ELN. The SDMS appears in contexts where data and information produced by the lab don't fit in the structure of what a LIMS or ELN handles.
#Identify CCPs.
#Establish critical limits for those CCPs.
#Establish monitoring procedures for those CCPs.
#Establish corrective action for failed limits.
#Establish verification procedures.
#Establish record keeping and documentation procedures.


===International Featured Standards (IFS)===
The IFS framework is made up of a group of eight food and non-food standards, covering various processes along the food supply chain. IFS Management, who is responsible for the standards, notes that "IFS does not specify what these processes must look like but merely provides a risk-based assessment"<ref name="IFSHome">{{cite web |url=https://www.ifs-certification.com/index.php/en/ |title=IFS: Global Safety and Quality Standards |publisher=IFS Management GmbH |accessdate=10 November 2022}}</ref> or "uniform evaluation system"<ref name="EagleFood19" /> for them. Organizations such as food manufacturers and logistics providers can certify to the standards. Some of the more relevant to food and beverage laboratories include IFS Food (for food manufacturers), IFS Global Markets Food (for food retailers), IFS PACsecure 2 (for packaging manufactures), and IFS Global Markets PACsecure (for packaging suppliers).<ref name="IFSStandards">{{cite web |url=https://www.ifs-certification.com/index.php/en/standards |title=IFS Standards |publisher=IFS Management GmbH |accessdate=10 November 2022}}</ref>


===International Organization for Standardization (ISO) 22000===
==3. How do I find the right solution for my needs?==
The [[wikipedia:ISO 22000|ISO 22000]] series of standards addresses how a food safety management system should be set up and operated, and how organizations can be certified to the standard by a third-party auditor.<ref name="ISO22000">{{cite web |url=https://www.iso.org/iso-22000-food-safety-management.html |title=ISO 22000 Food safety management |publisher=International Organization for Standardization |accessdate=10 November 2022}}</ref> ISO 22000 is based off the [[ISO 9000]] family of [[quality management system]] standards and, like other standards, incorporates elements of HACCP.<ref name="WeinrothHist18" /> The standard claims to be advantaged compared to other standards due to its comprehensive applicability across an entire organization, and across the entire food chain.<ref name="ISO22000Home">{{cite web |url=https://committee.iso.org/home/tc34sc17 |title=ISO/TC34/SC17 |publisher=International Organization for Standardization |accessdate=10 November 2022}}</ref> Major standards applicable to manufacturers with laboratories include:
[[File:Tallinn University of Technology 360 food-lab.jpg|left|500px]]As indicated above, the type of solution you choose is based on your lab type (e.g., service, research, production), the tests predominately run (e.g., chromatography work, requiring a CDS), and the type of data and information generated and stored (e.g., non-standard files, requiring an SDMS). However, finding the right system to fit your labs needs isn't a straightforward process. While your lab may know its [[Regulatory compliance|regulatory]]-, workflow-, and standard-driven requirements, perhaps critical personnel don't know much about [[Information management|data management]] solutions like LIMS, leaving a lab's key stakeholders intimidated by all the options. You'll first need to gauge your lab's informatics needs in order to determine which products are worth investigating further. Of course your lab's analysis requirements, reporting and data sharing constraints, instrument interfacing needs, [[Barcode|barcoding]] and tracking requirements, quality assurance processes, etc. are certainly important factors. But vendors' systems vary in numerous ways, and other important factors exist. Of course, price is one consideration, although value is ultimately more important than a low price. Other important questions that get asked include:
{{flowlist |
*Should we purchase software licenses or "rent" the software via a subscription-based model?
*Does the software need to be on-site, or is a [[Software as a service|SaaS]] hosted option more practical?
*Is a modular or complete system better for us?
*What is the best licensing/rental scheme for us? Should we consider site, named user, concurrent user, or workstation licenses?
*Is the company qualified and trustworthy?
*What functionality is available to help our lab remain compliant with the a variety of standards and regulations?
}}
===3.1 Technology considerations===
Your laboratory's workflow, instruments, data management requirements, budget, technological expertise, business goals, and [[Risk management|risk tolerances]] will all play a role in deciding what technology to invest in. Your lab will also be interested in how that technology not only helps with workflow requirements but also better assists the lab with meeting the requirements placed upon them by various standards and regulations, as well as management.


*ISO/TS 22002-1:2009 ''Prerequisite programmes on food safety — Part 1: Food manufacturing''<ref name="ISO22002-1">{{cite web |url=https://www.iso.org/standard/44001.html |title=ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing |publisher=International Organization for Standardization |date=December 2009 |accessdate=10 November 2022}}</ref>
As part of this discovery process, many questions may arise. Chief among them may be how to best match the laboratory's goals with one or more informatics solutions. Does the laboratory envision a small investment and modest goals, taking in a slow but steady flow of analytical requests, or do they envision expansive growth, expanding into multiple testing domains? If the lab is starting small but is confidently expecting to grow, technological investments early on may want to take into account future technologies that may shape data management and security processes. The lab will also want to account for how potential changes in standards and regulations may affect future expansion and technology needs.  
*ISO/TS 22002-4:2013 ''Prerequisite programmes on food safety — Part 4: Food packaging manufacturing''<ref name="ISO22002-4">{{cite web |url=https://www.iso.org/standard/60969.html |title=ISO/TS 22002-4:2013 Prerequisite programmes on food safety — Part 4: Food packaging manufacturing |publisher=International Organization for Standardization |date=December 2013 |accessdate=10 November 2022}}</ref>
*ISO/TS 22002-6:2016 ''Prerequisite programmes on food safety — Part 6: Feed and animal food production''<ref name="ISO22002-6">{{cite web |url=https://www.iso.org/standard/66126.html |title=ISO/TS 22002-6:2016 Prerequisite programmes on food safety — Part 6: Feed and animal food production |publisher=International Organization for Standardization |date=April 2016 |accessdate=10 November 2022}}</ref>


===Safe Quality Food (SQF) Program===
Second, ask what kind of work will the lab be doing, and what regulatory responsibilities will guide hardware and software investment at the lab. If your lab will be conducting extractable and leachable testing, you'll be considering [[chromatography]] and [[spectroscopy]] instruments and software systems, as well as requirements for retaining analytical results for regulators. Those labs accredited to standards such as ISO/IEC 17025 will have additional needs for instruments and software systems; such labs' data management system will likely need to be sufficiently robust to meet the needs of the standard. For those labs in more regulated spaces, the system will even need to interface to government systems, or at a minimum report in the regulatory body's specific format. These and other considerations will need to be made.
The SQF Program, headlined by the SQF Institute and recognized by the GFSI, is a food "safety-plus-quality" management certification mechanism that covers the food supply chain from farm to fork.<ref name="EagleFood19" /> Those who wish to be certified to SQF must comply with SQF Code, which covers a variety of topics, from aquaculture and farming to food packaging and food and feed manufacturing.<ref name="SQFCode">{{cite web |url=https://www.sqfi.com/resource-center/sqf-code-edition-9-downloads/ |title=SQF Code – Edition 9 Downloads |publisher=SQF Institute |date=24 May 2021 |accessdate=10 November 2022}}</ref> Like other standards, the organization wanting to be accredited finds a certified third-party auditor to administer program certification.


Third, your laboratory's budget is always important. Does the budget allow for on-site hardware and software systems, with the personnel to maintain them? Is it easier to pay up-front or find a vendor willing to work with you on leasing or rental terms? Is their more value to be had from a slightly more expensive system able to provide the functionality that makes regulatory compliance more painless for the lab?


==Regulations and laws around the world==
Finally, will the lab have someone on-site or on-call to resolve technology issues, including set-up and maintenance of software systems? If your lab will have little in the way of available tech help locally, you'll want to consider the distribution model you want to use for any installed software, i.e., you may want to consider [[software as a service]] (SaaS). An increasing number of software services are hosted using cloud computing, which when done well is an increasingly reliable option.<ref name="IzrailevskyCloud18">{{cite journal |title=Cloud Reliability |journal=IEEE Cloud Computing |author=Izrailevsky, Y.; Bell, C. |volume=5 |issue=3 |pages=39–44 |year=2018 |doi=10.1109/MCC.2018.032591615}}</ref> Having someone else host the software for you typically means the hosting provider will carry a non-trivial portion of responsibility for technology maintenance and security.  
The safety and quality of food is a high priority for most countries around the world, though how that safety and quality is regulated and legislated varies, sometimes significantly. The following subsections briefly address the primary regulations and legislation enacted in seven major countries and supranational unions around the world. (It is beyond the scope of this FAQ to address them all.) Similarities among the countries may be seen in their goals, but it should be noted that differences—significant and nuanced—exist among them all in regards to regulatory approaches to sampling, testing, risk, and importing<ref name="BuzbyFood03">{{cite web |url=https://www.ers.usda.gov/amber-waves/2003/november/food-safety-and-trade-regulations-risks-and-reconciliation/ |title=Food Safety and Trade: Regulations, Risks, and Reconciliation |author=Buzby, J.C.; Mitchell, L. |work=Amber Waves |publisher=U.S. Department of Agriculture, Economic Research Service |date=01 November 2003 |accessdate=13 November 2022}}</ref><ref name="GAOFoodSafety05">{{cite web |url=https://www.gao.gov/products/gao-05-212 |title=Food Safety: Experiences of Seven Countries in Consolidating Their Food Safety Systems |author=U.S. Government Accountability Office |date=February 2005 |accessdate=13 November 2022}}</ref><ref name="WhitworthReport22">{{cite web |url=https://www.foodsafetynews.com/2022/02/report-finds-food-testing-policies-different-between-countries/ |title=Report finds food testing policies different between countries |author=Whitworth, J. |work=Food Safety News |date=22 February 2022 |accessdate=13 November 2022}}</ref>, which should not be surprising given the cultural, political, and functional differences across regions and nations of the world.<ref name="BuzbyFood03" />


===Food Safety Act 1990 and Food Standards Act 1999 - ''United Kingdom''===
Speaking of security, you'll also want to consider the [[cybersecurity]] of not only your software solution but also your overall laboratory operations. Does your organization have a cybersecurity plan already in place, or has the decision to make one been postponed? What extra investment is required to ensure your sensitive data is secure? How do your cybersecurity goals compare to the demands of standards like ISO/IEC 17025? Remember that how you rank your cybersecurity preparedness and implement a cybersecurity plan will also guide your technology investment decisions.<ref name="DouglasComp20">{{cite web |title=[[LII:Comprehensive Guide to Developing and Implementing a Cybersecurity Plan|''Comprehensive Guide to Developing and Implementing a Cybersecurity Plan'']] |author=Douglas, S.E. |work=LIMSwiki |date=July 2020 |accessdate=20 January 2023}}</ref>
The [[wikipedia:Food Safety Act 1990|Food Safety Act of 1990]] and [[wikipedia:Food Standards Agency|Food Standards Act of 1999]] represent the core of food safety regulation in the United Kingdom, though there are other pieces of legislation that also have an impact.<ref name="SBCFood22">{{cite web |url=https://www.scarborough.gov.uk/home/business-licensing-and-grants/food-hygeine/food-safety-regulations |title=Food safety regulations |publisher=Scarborough Borough Council |date=10 November 2022 |accessdate=10 November 2022}}</ref><ref name="FSAKey22">{{cite web |url=https://www.food.gov.uk/about-us/key-regulations |title=Key regulations |publisher=Food Standards Agency |date=30 August 2022 |accessdate=10 November 2022}}</ref> The Food Safety Act of 1990 encourages entities to "not include anything in food, remove anything from food, or treat food in any way which means it would be damaging to the health of people eating it"; serve or sell food that is of a quality that "consumers would expect"; and ensure food is labeled, advertised, and presented clearly and truthfully.<ref name="SBCFood22" /><ref name="FSAKey22" /> The Food Standards Act of 1999 later created the UK's Food Standards Agency (FSA) "to protect public health from risks which may arise in connection with the consumption of food (including risks caused by the way in which it is produced or supplied) and otherwise to protect the interests of consumers in relation to food."<ref name="FSA99Sec1">{{cite web |url=https://www.legislation.gov.uk/ukpga/1999/28/section/1 |title=1999 c. 28, The Food Standards Agency, Section 1 |work=legislation.gov.uk |accessdate=10 November 2022}}</ref> One of the ways the FSA does this is through enforcing food safety regulation at the local level, including within food production facilities, as well as setting ingredient and nutrition labelling policy.<ref name="FSAAbout">{{cite web |url=https://www.gov.uk/government/organisations/food-standards-agency |title=Food Standards Agency |work=Gov.uk |accessdate=13 November 2022}}</ref> Regulations and guidance from the FSA address not only labelling but also radioactivity monitoring, meat processing, manure management, ''Salmonella'' testing, temperature control, dairy hygiene, and more.<ref name="FSAGuidReg">{{cite web |url=https://www.gov.uk/search/guidance-and-regulation?organisations%5B%5D=food-standards-agency&parent=food-standards-agency |title=Guidance and regulation: Food Standards Agency (FSA) |work=Gov.uk |accessdate=13 November 2022}}</ref>


===Food Safety and Standards Act of 2006 - ''India''===
===3.2 Functionality considerations===
This act was enacted in 2006 to both consolidate existing food-related law and to establish the Food Safety and Standards Authority of India (FSSAI), which develops regulations and standards of practice for the manufacture, storage, distribution, and packaging of food.<ref name="PRSImplement">{{cite web |url=https://prsindia.org/policy/report-summaries/implementation-food-safety-and-standards-act-2006 |title=Implementation of Food Safety and Standards Act, 2006 |work=PRS Legislative Research |accessdate=13 November 2022}}</ref><ref name="FSSAIFood">{{cite web |url=https://fssai.gov.in/cms/food-safety-and-standards-act-2006.php |title=Food Safety and Standards Act, 2006 |publisher=Food Safety and Standards Authority of India |accessdate=13 November 2022}}</ref> However, an audit of FSSAI by the Comptroller and Auditor General of India (CAG) in December 2017 revealed some deficiencies in the FSSAI's activities, including an overall "low quality" of food testing laboratories in the country.<ref name="PRSImplement" /> Nonetheless, the FSSAI remains the primary regulatory watchdog, developing standards and guidelines for food and enforcing those standards. This includes setting limits for food additives, contaminants, pesticides, drugs, heavy metals, and more, as well as defining quality control mechanisms, accreditation requirements, sampling and analytical techniques, and more.<ref name="FSSAIFood" />
Technology aside, the lab will also want to consider the functionality of the various laboratory informatics solutions offered by vendors. Some laboratorians may already be familiar with the LIMS or ELN and understand what it is capable of doing for the lab. However, others may have little familiarity with such systems and have only vague concepts of how they function. Either way, it's useful for the lab to gain a clearer understanding of what such solutions can do. There are several ways to go about this, from reading through examples of user requirements documents to participating in demonstrations of software from various vendors. In fact, both methods remain useful, and a standard approach to acquisition will usually include both. In the end, the question for any prospective vendor to answer is "how can your solution meet our laboratory's requirements?" This is where functionality comes in.


===Food Safety Law - ''China''===
The follow sections will look at functionality considerations first by introducing the user requirements specification (URS) as a means of learning more about system functionality. From there we'll look specifically at a LIMS and what its core and ancillary features look like, before finally re-addressing the URS from the perspective of how it can be implemented to full effect.
The [[wikipedia:Food safety in China|Food Safety Law]] is described as "the fundamental law regulating food safety in China."<ref name="UNEPFood15">{{cite web |url=https://leap.unep.org/countries/cn/national-legislation/food-safety-law-2015 |title=Food Safety Law (2015) |author=Food and Agriculture Organization of the United Nations |work=Law and Environment Assistance Platform |publisher=United Nations Environmental Programme |date=24 April 2015 |accessdate=13 November 2022}}</ref> Enacted in 2009 and revised in 2015, the Law "builds up the basic legal framework for food safety supervision and management" and  "introduces many new regulatory requirements," including "not only general requirements applicable to food and food additives, but also specific requirements for food-related products and other product categories."<ref name="UNEPFood15" /> Among these activities, the Law describes how food testing laboratories shall conduct their activities, from accreditation and sampling to testing and reporting.<ref name="USDAChina15">{{cite web |url=https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Amended%20Food%20Safety%20Law%20of%20China_Beijing_China%20-%20Peoples%20Republic%20of_5-18-2015.pdf |format=PDF |title=China's Food Safety Law (2015) |author=Foreign Agriculture Service Staff |publisher=U.S. Department of Agriculture |work=GAIN Repo |date=18 May 2015 |accessdate=13 November 2022}}</ref>


===Food Sanitation Act and Food Safety Basic Act - ''Japan''===
====3.2.1 The user requirements specification as a functionality guide====
The Food Sanitation Act of 1947 and the Food Safety Basic Act of 2003 represent the most important pieces of food-related legislation in Japan, though there are others. The Food Sanitation Act was originally enacted "to prevent sanitation hazards resulting from eating and drinking by enforcing regulations and other measures necessary from the viewpoint of public health, to ensure food safety and thereby to protect citizens' health."<ref name="JLTFood47">{{cite web |url=https://www.japaneselawtranslation.go.jp/en/laws/view/3687/en |title=Food Sanitation Act (Act No. 233 of 1947) |work=Japanese Law Translation |date=24 December 1947 |accessdate=13 November 2023}}</ref> The Food Safety Basic Act recognized the effects of "internationalization" and changing dietary habits, as well as scientific and technological shifts in food production, as a primary driver for modernizing food safety and sustainability in the country, and it also created the Food Safety Commission of Japan.<ref name="FSCFoodSafe03">{{cite web |url=https://www.fsc.go.jp/english/basic_act/fs_basic_act.pdf |format=PDF |title=Food Safety Basic Act |publisher=Food Safety Commission of Japan |date=23 May 2003 |accessdate=13 November 2022}}</ref> Between the two pieces of legislation, standards and specifications for food and food additives, as well as associated tools and packaging, are addressed, as are inspection standards, production standards, hygiene management, and individual food and ingredient safety.<ref name="BMFoodJapan18">{{cite web |url=https://resourcehub.bakermckenzie.com/en/resources/asia-pacific-food-law-guide/asia-pacific/japan/topics/food-product-and-safety-regulation |title=Japan: Food product and safety regulation |work=Asia Pacific Food Law Guide |author=Baker McKenzie |date=2018 |accessdate=13 November 2022}}</ref>
A specification is "a detailed precise presentation of something or of a plan or proposal for something."<ref name="MWSpec">{{cite web |url=https://www.merriam-webster.com/dictionary/specification |title=specification |work=Merriam-Webster |publisher=Merriam-Webster, Inc |accessdate=20 January 2023}}</ref> This concept of a specification as a presentation is critical to the laboratory seeking to find laboratory informatics software that fulfills their needs; they "present" their use case with the help of a requirements specification, and the vendor "presents" their ability (or inability) to comply through documentation and demonstration. However, even the most seasoned of presenters at conferences and the like still require quality preparation before the presentation. Similarly, your lab has work to do beforehand. This is where initial specification research comes into play for the lab.


===Food Safety Modernization Act (FSMA) and other acts - ''United States''===
Your lab's requirements specification document will eventually be a critical component for effectively selecting a laboratory informatics solution. For those labs with limited knowledge of what such a solution is capable of doing, building a URS can be especially useful. There are numerous ways to approach the overall development of a URS. But why re-invent the wheel when others have already gone down that road? Sure, you could search for examples of such documents on the internet and customize them to your needs, or you and your team could brainstorm how a laboratory informatics solution should help your lab accomplish its goals. Or you could turn to a robust URS like [[Book:LIMSpec 2022 R2|LIMSpec 2022]].  
The [[wikipedia:FDA Food Safety Modernization Act|Food Safety Modernization Act]] of the United States was signed into law in January 2011, giving the US Food and Drug Administration (FDA) more regulatory authority to address the way food is grown, harvested, and processed.<ref name="WeinrothHist18" /><ref name="FDAFood22">{{cite web |url=https://www.fda.gov/animal-veterinary/animal-food-feeds/food-safety-modernization-act-and-animal-food |title=Food Safety Modernization Act and Animal Food |publisher=U.S. Food and Drug Administration |date=20 October 2022 |accessdate=15 November 2022}}</ref> It has been described by the FDA as "the most sweeping reform of our food safety laws in more than 70 years."<ref name="FDAFood22" /> The FSMA, at its base, has five key aspects, addressing preventive controls, inspection and compliance, safety of food imports, mandatory recall response, and food partnership enhancement.<ref name="FDAFood22" /> However, FSMA continues to evolve, with additional rules getting added since its enactment, including rules about record management, good manufacturing practice (GMP) for human food and animal feed, and laboratory accreditation (referred to as the [[LII:FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors|LAAF Rule]]).<ref name="FDAFSMA22">{{cite web |url=https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry#rules |title=FSMA Rules & Guidance for Industry |publisher=U.S. Food and Drug Administration |date=20 October 2022 |accessdate=15 November 2022}}</ref>


Another important regulatory body in the US is the Food Safety and Inspection Service (FSIS), which is overseen by the US Department of Agriculture (USDA). The FSIS and its authority to regulate are derived from three different acts: the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957, and the Egg Products Inspection Act of 1970.<ref name="USDAOurHist18">{{cite web |url=https://www.fsis.usda.gov/about-fsis/history |title=Our History |author=Food Safety and Inspection Service |publisher=U.S. Department of Agriculture |date=21 February 2018 |accessdate=15 November 2022}}</ref> The FSIS has developed its own regulatory requirements for meat, poultry, and egg products, including for inspections, imports and exports, labeling, and laboratory testing.<ref name="9CFR412">{{cite web |url=https://www.ecfr.gov/current/title-9/chapter-III/subchapter-E/part-412 |title=9 CFR Part 412 - Label Approval |work=Code of Federal Regulations |date=31 October 2022 |accessdate=15 November 2022}}</ref><ref name="FSISFedReg">{{cite web |url=https://www.fsis.usda.gov/policy/federal-register-rulemaking/federal-register-rules |title=Federal Register Rules |publisher=Food Safety and Inspection Service |accessdate=15 November 2022}}</ref><ref name="NALFoodSafe">{{cite web |url=https://www.nal.usda.gov/human-nutrition-and-food-safety/food-safety-standards |title=Food Safety Standards |author=National Agricultural Library |publisher=U.S. Department of Agriculture |accessdate=16 November 2022}}</ref>
LIMSpec is a robust [[laboratory informatics]] requirements specification document that has evolved significantly over the years, and any lab can turn to LIMSpec to better visualize what the critical requirements of a LIMS (or other laboratory informatics solution) are. With the current version of LIMSpec having at its core standards such as [[ASTM E1578|ASTM E1578-18]] ''Standard Guide for Laboratory Informatics''<ref name="ASTME1578_18">{{cite web |url=https://www.astm.org/e1578-18.html |title=ASTM E1578-18 Standard Guide for Laboratory Informatics |publisher=ASTM International |date=23 August 2019 |accessdate=20 January 2023}}</ref> and ISO/IEC 17025 ''General requirements for the competence of testing and calibration laboratories''<ref name="ISO17025_17">{{cite web |url=https://www.iso.org/standard/66912.html |title=ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories |publisher=International Organization for Standardization |date=November 2017 |accessdate=20 January 2023}}</ref>, the LIMSpec makes for a durable URS that, when used to acquire an informatics solution, can better help a laboratory choose appropriate functionality based upon current standards, regulations, guidance, and more.  


===General Food Law Regulation (GFLR) - ''European Union''===
LIMSpec is divided into five distinct sections, with numerous subsections in each. These sections and subsections should be able to address most any requirement you have for your system. Of course, if something isn't covered by LIMSpec, you can always add additional requirements. More importantly, if you have little concept of what functionality systems such as a LIMS or SDMS should have, reviewing this URS can give you a leg up, as can participating in vendor demonstrations. Of course, the base LIMSpec can be used to develop your lab's custom URS to present to potential vendors. (More on that in a bit.)
The GFLR was enacted across the European Union in 2002 as part of Regulation (EC) No 178/2002, and it is described as "the foundation of food and feed law" for the EU.<ref name="EUGeneral">{{cite web |url=https://food.ec.europa.eu/horizontal-topics/general-food-law_en |title=General Food Law |work=Food Safety |publisher=European Commission |accessdate=14 November 2022}}</ref> Along with setting requirements and procedures for food and feed safety, the GFLR also mandated the creation of the European Food Safety Authority (EFSA), an independent body assigned to developing sound scientific advice about and providing support towards the goals of food, beverage, and feed safety in the EU.<ref name="WeinrothHist18" /><ref name="EUGeneral" /> As such, the EFSA develops broad and sector-specific guidance<ref name="EFSAGuidance">{{cite web |url=https://www.efsa.europa.eu/en/methodology/guidance |title=Guidance and other assessment methodology documents |publisher=European Food Safety Authority |accessdate=14 November 2022}}</ref>, as well as other rules related to scientific assessment of food safety matters, e.g., Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs.<ref name="EU2073-2005">{{cite web |url=https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32005R2073 |title=Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs |work=EUR-Lex |date=03 August 2020 |accessdate=15 November 2022}}</ref> The EFSA also develops food classification standardization tools such as the Standard Sample Description (SSD2) data model, to better ensure an appropriate "format for describing food and feed samples and analytical results that is used by EFSA’s data providers."<ref name="EFSAFoodClass">{{cite web |url=https://www.efsa.europa.eu/en/data/data-standardisation |title=Food classification standardisation – The FoodEx2 system |publisher=European Food Safety Authority |accessdate=14 November 2022}}</ref>


===Safe Food for Canadians Act (SFCA) - ''Canada''===
====3.2.2 Core functions and features====
In November 2012, the SFCA was enacted to place regulatory "focus on prevention to ensure a food that is imported, exported or shipped from one province to another, is manufactured, stored, packaged and labelled in a way that does not present a risk of contamination."<ref name="ManitobaSafe">{{cite web |url=https://www.gov.mb.ca/agriculture/food-safety/at-the-food-processor/safe-food-for-canadians-act.html |title=Safe Food for Canadians Act |publisher=Manitoba Government |accessdate=15 November 2022}}</ref><ref name="JLWSafeFood19">{{cite web |url=https://laws-lois.justice.gc.ca/eng/acts/s-1.1/index.html |title=Safe Food for Canadians Act (S.C. 2012, c. 24) |work=Justice Laws Website |publisher=Government of Canada |date=17 June 2019 |accessdate=15 November 2022}}</ref> Though Canadian Food Inspection Agency (CFIA) enforcement of the SFCA's regulations didn't start until January 2019<ref name="ManitobaSafe" />, the consolidation of 14 sets of existing food regulations by the SFCA has managed to improve consistency, reduce administrative burden, and enable food business innovation.<ref name="GoCUnder18">{{cite book |last=Canadian Food Inspection Agency |year=2018 |title=Understanding the Safe Food for Canadians Regulations: A handbook for food businesses |url=https://inspection.canada.ca/food-safety-for-industry/toolkit-for-food-businesses/sfcr-handbook-for-food-businesses/eng/1481560206153/1481560532540?chap=0 |publisher=Government of Canada |isbn=9780660269856}}</ref> An interpretive guide published by the CFIA, ''Understanding the Safe Food for Canadians Regulations: A handbook for food businesses'', summarizes and explains some of the nuances of the SFCA and its 16 parts on matters such as trade, licensing, preventive controls, packaging and labeling, and traceability.<ref name="GoCUnder18" />
While laboratory, scientific, and clinical informatics vendors may provide a similar core set of functionality in their solutions, there's still a lot of room for variance. Some vendors may try to make a one-size-fits-all solution, while others may focus on certain specialties or uses. In the end, despite the different approaches, a certain set of core functionality becomes apparent. This guide will focus on the LIMS/LIS and its functionality. You should expect the following functionality to be demonstrated in a mature and professional LIMS/LIS offering:


'''''Test, experiment, and entity management'''''


==Other influencing factors==
*sample/specimen log-in and management, with support for unique IDs
Several other organized efforts towards better food quality are worth mentioning, often influencing the development of standards and regulations of other entities around the world.
*batching support
*barcode and RFID support
*sample/specimen tracking
*pre-defined and configurable industry-specific test and method management
*pre-defined and configurable industry-specific workflows
*clinical decision support (for clinical)
*event and instrument scheduling
*templates, forms, and data fields that are configurable
*analytical tools, including data visualization, trend analysis, and data mining features
*data import and export
*robust query tools
*document and image management, with support for unique document numbers
*project and experiment management
*case management (for clinical and forensic)
*supplier/vendor/customer/patient management
*storage management and monitoring


===Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)===
As a broad concept, [[good manufacturing practice]] or GMP is an organized set of standards and guidelines that allow manufacturers of most any product to better ensure their products are consistently produced and packaged to a consistent level of quality. GMP tends to cover most every step of production, from planning recipes and choosing starting materials to training personnel and documenting processes.<ref name="ISPEGMP">{{cite web |url=https://ispe.org/initiatives/regulatory-resources/gmp |title=Good Manufacturing Practice (GMP) Resources |publisher=International Society for Pharmaceutical Engineering, Inc |accessdate=15 November 2022}}</ref> The concept of GMP is often spoken of in terms of pharmaceutical and medical device manufacturing<ref name="ISPEGMP" /><ref name="WHOMedicines15">{{cite web |url=https://www.who.int/news-room/questions-and-answers/item/medicines-good-manufacturing-processes |title=Medicines: Good manufacturing practices |publisher=World Health Organization |date=20 November 2015 |accessdate=15 November 2022}}</ref>, though it is applicable to most any other production industry<ref name="CEReg07">{{cite web |url=https://www.controleng.com/articles/regulated-or-not-know-good-manufacturing-practices-gmp/ |title=Regulated or not? Know good manufacturing practices (GMP) |author=''Control Engineering'' Staff |work=Control Engineering |date=14 July 2007 |accessdate=15 November 2022}}</ref><ref name="FDAGMPCosm22">{{cite web |url=https://www.fda.gov/cosmetics/cosmetics-guidance-documents/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics |title=Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics |publisher=U.S. Food and Drug Administration |date=25 February 2022 |accessdate=15 November 2022}}</ref>, including the food and beverage industry.<ref name="FDAGoodMan17">{{cite web |url=https://www.who.int/news-room/questions-and-answers/item/medicines-good-manufacturing-processes |title=Good Manufacturing Practices for the 21st Century for Food Processing (2004 Study) Section 1: Current Food Good Manufacturing Practices |publisher=U.S. Food and Drug Administration |date=27 December 2017}}</ref><ref>{{Cite book |last=Manning |date=2013-01-11 |title=Food & Drink - Good Manufacturing Practice: A Guide to its Responsible Management |url=http://doi.wiley.com/10.1002/9781118318225 |language=en |publisher=Wiley-Blackwell |place=Oxford, UK |doi=10.1002/9781118318225 |isbn=978-1-118-31822-5}}</ref>


Closely related is the term "current good manufacturing practice" or cGMP. Both "GMP" and "cGMP" are largely interchangeable, though the latter is preferred in most regulatory language of the United States. A more nuanced take says that cGMP essentially represents the newest, most updated technologies implemented towards the goals of meeting GMP requirements.<ref name="PSDiff21">{{cite web |url=https://www.pharmaspecialists.com/2021/10/difference-between-gmp-and-cgmp.html#gsc.tab=0 |title=Difference Between GMP and cGMP |work=Pharma Specialists |date=13 October 2021 |accessdate=15 November 2022}}</ref><ref name="MoravekTheDiff">{{cite web |url=https://www.moravek.com/the-differences-between-gmp-and-cgmp/ |title=The Differences Between GMP and cGMP |work=Moravek Blog |publisher=Moravek, Inc |date=January 2021 |accessdate=15 November 2022}}</ref> In the United States, cGMP—in the context of food—was first introduced in 1969 as 21 CFR Part 110, though the concept of cGMP was modernized in 2015, in 21 CFR Part 117. This led to not only broad food- and beverage-based cGMPs but also cGMPs specific to a type of ingestible, including dietary supplements, infant formula, low-acid canned food, and bottled water.<ref name="FDACurrentGood20">{{cite web |url=https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements |title=Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements |publisher=U.S. Food and Drug Administration |date=31 January 2020 |accessdate=15 November 2022}}</ref>
'''''Quality, security, and compliance'''''


===Standards and Scientific Advice on Food and Nutrition (SSA)===
*quality assurance / quality control mechanisms
The WHO's Nutrition and Food Safety (NFS) Department envisions "a world free from all forms of malnutrition and foodborne diseases, within safe and supportive societies and healthy environments."<ref name="WHONFSHome">{{cite web |url=https://www.who.int/teams/nutrition-and-food-safety/overview |title=Nutrition and Food Safety - Vision and Mission |publisher=World Health Organization |accessdate=15 November 2022}}</ref> One way they attempt to make that vision a reality is through its SSA Unit, described as "the focal point for WHO’s work on international standard-setting in food safety and nutrition."<ref name="WHONFS_SSA">{{cite web |url=https://www.who.int/teams/nutrition-and-food-safety/standards-and-scientific-advice-on-food-and-nutrition |title=Nutrition and Food Safety - Standards and Scientific Advice on Food and Nutrition (SSA) |publisher=World Health Organization |accessdate=15 November 2022}}</ref> The SSA consists of a number of committees that develop scientific risk assessments and guidelines, which in turn make their way into the Codex Alimentarius and other national regulations and standards. These assessments and guidelines cover a variety of topics, including microbiological risk management, drug residues, food contaminates and additives, microplastics, and allergens, among others.<ref name="WHONFS_SSA" />
*changed, amended, or re-issued report management
*data normalization and validation
*results review and approval
*trend and control charting for statistical analysis and measurement of uncertainty
*version control
*user qualification, performance, and training management
*audit trails and chain of custody support
*configurable and granular role-based security
*configurable system access and use (log-in requirements, account usage rules, account locking, etc.)
*electronic signature support
*configurable alarms and alerts
*data encryption and secure communication protocols
*data archiving and retention support
*configurable data backups
*environmental monitoring and control
*incident and non-conformance notification, tracking, and management
*instrument lock-out




==Conclusion==
'''''Operations management and reporting'''''
This brief topical article sought to answer "what standards and regulations affect a food and beverage laboratory?" What becomes evident from attempting to answer this question is that while many standards and regulations don't exclusively apply to food and beverage laboratories, many such labs are affected indirectly. In order for the food and beverage industry to be a safer, more well-trusted industry, it must incorporate quality control and standardized manufacturing methods into its efforts, which in turn require laboratory analyses to ensure meeting those quality and manufacturing standards. These industry labs may also have their own analytical, credentialing, and record keeping requirements, derived either directly from regulations and standards affecting the labs, or secondarily as a means to accurately measure quality and safety with the broader producer. Many such standards may be internationally applicable, such as the ISO 22000 series of standards, in recognition of a growing push to harmonize food safety laws, regulations, and standards on a global scale.<ref name="FDAIntern22">{{cite web |url=https://www.fda.gov/food/international-interagency-coordination/international-cooperation-food-safety |title=International Cooperation on Food Safety |publisher=U.S. Food and Drug Administration |date=03 November 2022 |accessdate=16 November 2022}}</ref> As a result, the regulations found in countries like Japan and the United States may have many similarities, while still recognizing there are cultural, political, and functional differences among them that dictate important differences.<ref name="BuzbyFood03" /> From this brief analysis, we learn of the more important standards affecting the food and beverage industry, and we discover representative examples of regulation around the world, which tend to be driven by the prior-mentioned standards.
 
*configurable dashboards
*customizable rich-text reporting, with multiple supported output formats
*custom and industry-specific reporting, including certificates of analysis (CoAs)
*synoptic reporting (for clinical)
*industry-compliant labeling
*email integration
*internal messaging system
*revenue management
*instrument interfacing and data management
*instrument calibration and maintenance tracking
*inventory and reagent management
*third-party software and database interfacing
*data import and export
*mobile device support
*voice recognition capability
*results portal for external parties
*integrated (or online) system help
*configurable language
 
====3.2.3 Additional useful features====
The following features are examples of additional LIMS/LIS functionality beyond the core functions a laboratory may seek (it is not meant to be a complete list):
 
*audit management
*clinical research support
*complaint management
*customer relationship management
*electronic laboratory notebook support
*ERP and accounting interfaces
*inventory reconciliation
*invoicing and quotation support
*product specification management
*project management
*recipe management
*reflex testing support
*safety tracking and compliance
*single sign-on support
*stability testing management
 
===3.3 System flexibility===
[[File:Laboratorio de Paleoetnobotánica y Paleoambiente, área de microscopia.jpg|right|400px]]Before selecting a solution, your laboratory should also have internal discussions about how diversified its offered services are, as well as what the future may bring to the lab. If, for example, your lab is currently configured for one type of testing, does your existing laboratory informatics system—or the ones you may be considering—have the flexibility to add other types of testing, protocols, and workflows? Will you be doing the footwork to add them, or will the vendor of your system support you in that effort? If you're a start-up, will your lab be focusing solely on a specific type of testing and expand into other types of analytical work later, or will your test menu need to be much broader right from the start? In most of these cases, you'll desire software that is flexible enough to allow for not only running the specific tests you need now, but also sufficiently expandable for any future testing services your lab may conduct in the mid- and long-term. Having the ability to create and customize [[Sample (material)|sample]] registration screens, test protocols, labels, reports, specification limit sets, measurement units, and substrates/matrices while being able to interface with practically most any instrument and software system required will go a long way towards making your expanding test menu and workflows integrates as smoothly as possible.
 
Such a system will typically be marketed as being highly user-configurable, giving labs a relatively painless means to adapt to rapid changes in test volume and type over time. However, once you've internally addressed current and anticipated future growth, your lab will want to learn what explicitly makes any given vendor's system user-configurable. How easy is it to configure the system to new tests? Add custom reports? What knowledge or skills will be required of your lab in order to make the necessary changes, i.e., will your staff require programming skills, or are the administrator and advanced user functions robust enough to make changes without hard-coding? These and other such questions should be fully addressed by the vendor in order to set your mind at ease towards a system's stated flexibility. Ultimately, you want the system to be flexible enough to change with the laboratory—and industry—itself, while minimizing overall costs and reducing the time required to make any necessary modifications.
 
===3.4 Regulatory compliance considerations===
When considering their laboratory informatics solutions, labs will also want to take regulatory- and standard-based compliance into consideration. In regards to regulatory compliance in particular, it may be helpful to approach the topic from the standpoint of adopting standards. Consider first that the risks and consequences of performing a task poorly drives regulation and, more preferably<ref name="CiocoiuTheRole10">{{cite book |chapter=Chapter 1. The Role of Standardization in Improving the Effectiveness of Integrated Risk Management |title=Advances in Risk Management |author=Ciocoui, C.N.; Dobrea, R.C. |editor=Nota, G. |publisher=IntechOpen |year=2010 |isbn=9789535159469 |doi=10.5772/9893}}</ref><ref name="JPMorganData18">{{cite web |url=https://www.jpmorganchase.com/content/dam/jpmc/jpmorgan-chase-and-co/documents/call-to-action.pdf |format=PDF |title=Data Standardization: A Call to Action |publisher=JPMorgan Chase & Co |date=May 2018 |accessdate=20 January 2023}}</ref>, standardization, which in turn moves the "goalposts" of quality and security among organizations. In the case of regulations, those organization that get caught not conforming to the necessary regulations tend to suffer negative consequences, providing some incentive for them to improve organizational processes and procedures.
 
One of the downsides of regulations is that they can at times be "imprecise" or "disconnected"<ref name="JPMorganData18" /> from what actually occurs within the organization and its information systems. Rather than focusing heavily on regulatory conformance, well-designed standards may, when adopted, provide a clearer path of opportunity for organizations to improve their operational culture and outcomes, particularly since standards are usually developed with a broader consensus of interested individuals with expertise in a given field.<ref name="CiocoiuTheRole10" /> In turn, the organizations that adopt well-designed standards (e.g., ISO/IEC 17025) likely have a better chance of conforming to the regulations they must, and they'll likely have more interest in maintaining and improving the goalposts of quality and security in the lab.
 
Additionally, reputable software developers of laboratory informatics software will not only adopt their own industry standards for software development but also understand how regulations, standards, and LIMS requirements intersect. Given that understanding, the developed software should meet regulations and standards, help the laboratory comply with its regulations and standards, and be of reliably good quality.
 
If you're a potential buyer of a laboratory informatics solution, it may be that you know a bit about your laboratory's workflow and have at least a remedial understanding of how certain regulations and standards influence how that workflow is conducted, but you're not entirely informed about all the details of how a LIMS can help your lab better conform. Turning to a URS such as LIMSpec—which was developed around laboratory regulations and standards, including ISO/IEC 17025—and reviewing the various statements contained within may be necessary to help further inform you. Additionally, as you investigate various informatics options, you can then use the requirements in the URS as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the base URS. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query. And since your URS is based off the standards and regulations affecting your lab, you can feel more confident in your acquisition and its integration into your laboratory workflow.
 
===3.5 Putting a URS to work for your lab===
As stated prior, building a URS specific to your lab can easily start by examining an existing URS like LIMSpec, which covers most functionality a laboratory could need out of their informatics solution. However, LIMSpec is extensive in what it covers. During the initial research put towards your URS, know that you likely don't want to send the full, comprehensive URS to vendors, at least not in the initial discovery stages. Most vendors appreciate a more inviting approach that doesn't initially overwhelm. Early on you're better off to go with a limited yet practical set of requirements carefully chosen because they matter to you and your laboratory the most. For a food and beverage laboratory, support for molecular biology workflows, stability studies, and production management could be critical. In the case of a lab seeking a solution to help them better comply with ISO/IEC 17025, the lab might want to focus on requirements related to complying with the standard.
 
However you choose to approach URS development and presentation, you'll likely want to wait until after participating in several vendors' software demonstrations before even considering your URS to be complete. The demo offers a unique and valuable opportunity to see in-person how data and information is added, edited, deleted, tracked, and protected within the context of the application; you can ask about how a function works and see it right then and there. Equally, it is an excellent time to compare notes with the vendor, particularly in regard to requirements your lab deems being critical. You can ask the vendor in real-time to answer questions about how a specific task is achieved, or how the system addresses specialized needs, and the vendor can ask you about your lab's system and workflow requirements and how you best envision them being implemented in the system.
 
Again, be careful about falling for the temptation of presenting a full URS or other specification document to the vendor during the demonstration. You'll want to wait until after participating in several software demonstrations to consider presenting your full specification document to the vendor, and that's assuming that you've grown enamored with their solution. By waiting to finalize your lab's URS until after the demos, a common error is avoided: too often labs think the first thing they must do is create a requirements list, then sit back and let the informatics vendors tell them how they meet it. Remember that even though most labs thoroughly understand their processes, they likely don't have as strong a grasp on the informatics portion of their processes and workflows. Participating in a demo before finalizing your list of specified requirements—or having only a minimal yet flexible requirements list during the demo—is a great way to later crosscheck the software features you have seen demonstrated to your lab's processes and any initial requirements specification you've made.<ref name="HammerHowTo19">{{cite web |url=https://www.striven.com/blog/erp-software-demo |title=How to Get the Most Value from an ERP Software Demo |author=Hammer, S. |work=The Takeoff |date=27 June 2019 |accessdate=02 February 2023}}</ref> After all, how can you effectively require specific functions of your laboratory informatics software if you don't fully know what such a system is capable of? After the demonstrations, you may end up adding several requirements to your final specifications document, which you later pass on to your potential vendors of choice for final confirmation.
 
In some cases, rather than approaching vendors, a lab may want to take a different exploratory route by issuing a [[request for information]] (RFI) or something similar. An RFI is an ideal means for learning more about a potential solution and how it can solve your problems, or for when you're not even sure how to solve your problem yet. However, like when approaching a vendor directly, the RFI should not be unduly long and tedious to complete for prospective vendors; it should be concise, direct, and honest. This means not only presenting a clear and humble vision of your own organization and its goals, but also asking just the right amount of questions to allow potential vendors to demonstrate their expertise and provide a clearer picture of who they are. Some take a technical approach to an RFI, using dense language and complicated spreadsheets for fact finding. However, as previously noted, you will want to limit the specified requirements in your RFI to those carefully chosen because they matter to you and your lab the most.<ref name="HolmesItsAMatch">{{cite web |url=https://allcloud.io/blog/its-a-match-how-to-run-a-good-rfi-rfp-or-rfq-and-find-the-right-partner/ |title=It's a Match: How to Run a Good RFI, RFP, or RFQ and Find the Right Partner |author=Holmes, T. |work=AllCloud Blog |accessdate=02 February 2023}}</ref>
 
Remember, an RFI is not meant to answer all of your questions. The RFI is meant as a means to help narrow down your search to a few quality candidates offering functionality that meets your needs, while also learning more about each other.<ref name="HolmesItsAMatch" /> Once the pool of potential software vendors is narrowed down, and you then participate in their demonstrations, you then can broadly add more requirements to the original collection of critical requirements from the RFI to ensure those vendors can meet all or most of your needs. That said, be cognizant that there may be no vendor that can meet each and every need of your lab. Your lab will have to make important decisions about which requirements are non-negotiable and which are more flexible. The vendors you engage with may be able to provide realistic advice in this regard, based upon your lab's requirements and their past experience with labs. As such, those vendors with real-world experience meeting the needs of laboratories like your may have a strong leg up on other vendors.
 
Ultimately, your URS may look similar to LIMSpec, or it may have a slightly different format. Many prospective buyers will develop a requirement specification in Microsoft Excel, but that has a few minor disadvantages. Regardless of format, you'll want to give plenty of space for vendors to submit a response to each requirement. With a more complete URS in hand, and your vendor list narrowed down to a few possibilities, you're ready to submit the full URS to those vendors. Other considerations come into play afterwards, depending how those vendors' respond to you URS. How well did the vendors respond to your laboratory's unique set of needs? Were there critical areas that one vendor could address with their off-the-shelf solution but another vendor would have to address with custom coding? Did any of the vendors meet your budget expectations? Have you followed up on any references and customer experiences the vendors provided to you?
 
 
==4. What other considerations should I make, and how much will it cost?==
[[File:U.S. Department of Energy - Science - 389 011 005 (9954756034).jpg|left|320px]]Hopefully, once all the due diligence is done, and with a little luck, you've found a vendor that fits your technology and functionality needs, even if a few minor compromises had to be made along the way. However, there's obviously more than technology and system functionality to consider! What are some implementation considerations? How is the vendor's solution offered: in the cloud or locally? What kind of licensing is used? What are the specifics of the maintenance, warranty, and support plans? And of course, what sort of cost (better to think of it in terms of "investment") is involved? This next section addresses these questions and more.
 
===4.1 Implementation===
If you've ever worked through a system implementation process with a vendor, it was hopefully a smooth process. However, there are plenty of horror stories out there, highlighting the need of the laboratory to discuss in detail how a potential vendor will handle installation, validation, and training for the informatics solution. Does the vendor truly understand the industry and your needs? Does the vendor assign a project manager who will work with you, from planning to go-live and beyond? Can they offer you references of other labs who have gone through implementation so you can compare notes with those labs? How much attention does the potential vendor give to related issues such as data integrity of migrated data? Do they have the means to properly handle your legacy data? And are they able to work with your schedule, even if it means implementing software at off-peak work hours?<ref name="Wagner7Soft19">{{cite web |url=https://blog.walkme.com/7-software-implementation-challenges/ |title=7 Software Implementation Challenges and How to Solve Them |author=Wagner, M. |work=WalkMe Blog |publisher=WalkMe Ltd |date=10 October 2019 |accessdate=20 January 2023}}</ref><ref name="MuraBullet18">{{cite web |url=https://www.userlane.com/software-implementation-plan/ |title=Bullet-Proof Software Implementation Plan: Challenges and Tactics |author=Mura, A. |work=Userlane Digital Adoption Blog |publisher=Userlane GmbH |date=12 July 2018 |accessdate=20 January 2023}}</ref>
 
As you finally get down to the ultimate decision on which vendor to work with, you may wish to start setting up an implementation checklist as part of your early project planning. Do you receive a help desk account as part of the implementation process, and if so, what information is included? If not, you'll need to keep track of specific details such as business associate agreement (BAA), sales agreement, scope documents, welcome letters, documentation, and approved staff who can utilize the vendor's support. You'll likely need to share other configuration details with the vendor, including time zone requirements, DNS and URL requirements, up-time monitors, and administrative account requirements. Finally, you'll want to ensure you and the vendor are on the same page concerning any additional customization, integration, and system validation requirements, ensuring the roll-out period is pain-free and efficient.
 
====4.1.1 Internal and external integrations====
Laboratories acquire data management software for many reasons, including improving accuracy and quality, saving time, increasing productivity, and adding capabilities. One way of doing all of those activities is to integrate or interface your systems, databases, and instruments so that human error is greatly reduced or eliminated, workflows are automated and sped up, and each component's capabilities are brought into play in the most efficient and effective ways possible. As such, you'll want to inquire with the vendor about its solution's hardware and software integration capabilities. Is it designed to interface with every laboratory instrument or software that can output any readable electronic file? Or are integrations limited to certain instruments and systems? How does it connect, i.e., what protocols does the software depend on to connect with other systems? Does the system allow a user to map their own file imports and exports? Can system processes be set to detect new instances of file outputs at regular intervals? Ask these and other questions to make sure the vendor clearly describes what internal and external integrations are supported with their application.
 
In many cases, a vendor's LIMS solution will have instrument integration capability built into the software, but occasionally such interfaces are separate from the main software. Today's instrument interfaces are generally built on standardized communication protocols such as RS-232, RS-422, IEEE-488 (GPIB), USB, Ethernet, and more.<ref name="WilliamsComp">{{cite web |url=https://newton.ex.ac.uk/teaching/CDHW/Interfaces/ |title=Computer Interfaces for Instrumentation Systems |author=Williams, C.D.H. |publisher=University of Exeter |accessdate=20 January 2023}}</ref> The LIMS that can support such instrument integrations is increasingly vital to the ISO/IEC 17025 laboratory. Such labs may also want their laboratory informatics solution to be able to communicate with other software and databases. This is often done using [[application programming interface]]s (APIs) that depend on web services implementation protocols such as REST and SOAP.<ref name="MonusSOAP19">{{cite web |url=https://raygun.com/blog/soap-vs-rest-vs-json/ |title=SOAP vs REST vs JSON - a 2023 comparison |author=Monus, A. |work=Raygun |date=17 October 2022 |accessdate=20 January 2023}}</ref><ref name="LVAQuick18">{{cite web |url=https://www.labvantage.com/a-quick-guide-to-lims-web-services/ |title=A Quick Guide to LIMS Web Services |author=LabVantage Solutions |publisher=LabVantage Solutions, Inc |date=07 January 2018 |accessdate=20 January 2023}}</ref><ref name="GrandOneTool19">{{cite journal |title=One tool to find them all: A case of data integration and querying in a distributed LIMS platform |journal=Database |author=Grand, A.; Geda, E.; Mignone, A. et al. |volume=2019 |page=baz004 |year=2019 |doi=10.1093/database/baz004}}</ref> These messaging protocols actually allow for the creation of an API that receives communication requests and sends responses between two software systems. A more practical example is wanting your laboratory informatics solution to communicate with an [[enterprise resource planning]] (ERP) application or a QMS. Perhaps rather than housing quality management documents exclusively in the LIMS, the lab has had a dedicated electronic QMS for years, and they'd like to be able to interface that with the LIMS. APIs and communication protocols make this happen.<ref name="LVAQuick18" />
 
===4.2 MSW, updates, and other contracted services===
The maintenance, support, and warranty (MSW) offered with the vendor's solution is almost as important as the solution itself. The laboratory informatics solution you acquire is more than than the software you operate: it's mission-critical and deserves having a reliable and responsive team with the necessary resources to ensure it remains operational. Downtime can negatively affect both immediate customer satisfaction and your reputation. As such, it's imperative you ask the vendor about the details of its MSW, making sure you understand what is and isn't covered, as well as how much it will cost (discussed in the next section). Cost-wise, industry norms are anywhere from 15% to 25% of either the license fee or total contract, levied annually to provide this coverage.<ref name="ScavoHigh05">{{cite web |url=https://www.computereconomics.com/article.cfm?id=1033 |title=High Software Maintenance Fees and What to Do About Them |author=Scavo, F. |work=Computer Economics |date=08 February 2005 |accessdate=20 January 2023}}</ref> Alternatively, it may simply be included with your subscription. The MSW will include a specified number of support and maintenance hours or guarantees. The actual warranty should be unlimited for as long as the MSW or subscription is kept current.
 
Maintenance includes any and all work necessary to keep your system working as designed. It should include updates, patches, or fixes, and most if not all upgrades. (Note, however, a major upgrade to a totally new edition may not be covered, but it may come at a negotiable, significantly lower cost.<ref name="Gordon-ByrneMaint14">{{cite web |url=http://www.ittoday.info/ITPerformanceImprovement/Articles/2014-08GordonByrne2.html |archiveurl=https://web.archive.org/web/20210505220938/http://www.ittoday.info/ITPerformanceImprovement/Articles/2014-08GordonByrne2.html |title=Maintenance in the Digital World |author=Gordon-Byrne, G. |work=IT Performance Improvement |publisher=Taylor & Francis, LLC |date=2014 |archivedate=05 May 2021 |accessdate=20 January 2023}}</ref>) The support aspect of MSW generally consists of a specified number of hours dedicated more to helping you with the operation of the system rather than "fixing" anything. Support includes guidance on training, password or login support, and more. Finally, with any professional application you also expect to have a warranty. The warranty should cover anything that doesn't work that otherwise should for the designated period of time.<ref name="Gordon-ByrneMaint14" /> That includes any standard features and functions, as well as any additional ones that were delivered and signed off on, and any other work performed by the vendor or its representatives. However, a typical warranty does not cover anything that was working fine, but upon being manipulated in a way beyond normal operation the functionality ceased. In these cases, you'll probably have to pay to get it fixed.
 
Beyond the MSW, additional updates and services related to the system may also be required. No matter how well it is pre-configured, any professional laboratory informatics solution will require some amount of standard setup to reflect your particular lab. This includes adding lab branding and demographics for reports and certificates; entering users, their roles, and access permissions; adding and/or modifying tests and workflows; renaming fields; adding or hiding fields; setting up a web portal; and implementing interfaces. Equally indispensable is proper training for both users and administrators. And of course you may later find that you would like additional features or functions. These and other services may prove particularly useful to the laboratory with little in the way of IT and systems expertise. As such, the vendor may provide one or more of the following as a billable service for the laboratory:
 
*initial implementation meeting (e.g., initial planning, identify delta, set schedule)
*project management
*requirements gathering and documentation
*initial setup
*user and administrator training
*configuration and customization
*interface development and implementation
*custom screen and field development
*custom functionality development
*custom reports and labels
*custom triggers and alerts
*validation or acceptance testing (to a third-party standard or certification, or to agreed manufacturer specs)
 
===4.3 Cost considerations===
[[File:Dollar symbol.jpg|right|300px]]First, you'll want to be clear on what will be included in the sales agreement. Whether through an estimate or statement of work (SOW), it is important it includes exactly what is expected, being as specific as possible, since this will be the entire contractual obligation for both you the buyer and them the vendor. Note that line items may differ slightly from system to system, according to what features and functions are included by default with each vendor's solution and which, if any, are additional. Also keep in mind that any hourly amount in the the estimate or SOW is usually a best estimate; however, if sufficient attention to detailed requirements has been given, then it should be quite accurate, and in fact the final cost may even be below the quoted cost if you prioritize your own obligations so that the vendor's hours are used sparingly and efficiently.
 
The estimate or SOW should optimally include:
 
*licensing or subscription rates;
*required core items to meet federal, state, and local regulations;
*additional optional items and totals; and
*required services (implementation, maintenance and support, optional add-ons).
 
There are two primary ways to price a laboratory informatics solution: a one-time license fee or a subscription rate (cloud-hosted SaaS). If you have your own dedicated IT department and staff, you may prefer the former (although many system administrators are just as happy to let it be hosted elsewhere rather than add to their workload). Otherwise, a SaaS subscription may well be the better and more cost-effective way to go (since the primary IT cost is simply internet access). This item will be part of your up-front cost and, in the case of subscription, it will also figure into your first year and ongoing costs; otherwise only associated MSW will figure in. Typically, your first year's subscription costs will be due at signing. More often, the vendor may require three months or even the first year up front, so be prepared to factor that into up-front costs. However, it still is almost always less expensive at the outset (and over time, if you factor in IT costs and annual MSW) than paying for a license fee.
 
In addition to the two types of software pricing, there are also sub-types. Generally these are based on the number of users (or, in some cases, "nodes," which are simply any entities that access the informatics system, including other systems, instruments, etc.). How these are counted can vary.
 
*Named users: This method bases pricing on the actual individual users of the system, even if they only log in sporadically. Users may not use each other's logins (this is a no-no regardless of pricing structure, for good laboratory practice and other regulatory reasons).
*Concurrent users: This bases pricing on the maximum number of users who will be logged in at any given time. You can define an unlimited number of named users in the system, each with their own login credentials. However, only the number of concurrent users specified in the license or subscription may be logged in at any one time. For example, you may have 10 staff, but due to work processes, shifts, etc., only up to six might ever be logged in simultaneously. Whereas this would require a named user license for 10, it would only require a concurrent user license for six.
*Unlimited users: In the case of very large labs (typically 30 to 50 and up), the license or subscription may simply be a flat fee that allows any number of users.
 
The line items in the estimate or SOW should reflect these nuances, as well as whether the listed costs are monthly or annual (for subscription services), hourly (typically for support and training), or a fixed one-time cost. Additionally, be cautious with fixed costs, as they typically represent one of two possible scenarios:
 
#Final fixed cost: In this case, the cost has been figured by the vendor so as to cover their worst-case hourly labor total. If a line item (e.g., an interface) is not "worst case," then you are overpaying.
#"Expandable" fixed cost: This is as bad as final fixed cost, and maybe even worse because it's almost a case of "bait-and-switch," popping up as a surprise. The initial "fixed cost" number is low, and additional hourly services are needed to actually deliver the item. This will have been provided for somewhere in the small print.
 
The bottom line is that everything in a laboratory informatics solution is really either licensing or hourly services. Just be careful if they are portrayed as anything else.
 
It is important to be clear which category each line item falls under when figuring costs: up-front (due upon signing), annual, or ongoing (e.g., SaaS subscription). It is useful to clearly lay out each and compute initial costs, as well as first-year and subsequent years' costings. For example, your initial obligation may be as little as your first year's subscription plus the first 40 hours of services. Different vendors have different policies, however, and you may be required to pay for your first full year's subscription and all services, or some other combination. Normally, though, any instrument interface or other service charges aren't due until the they are implemented, which may be a few weeks or even a month down the road. This may depend on your budget, complexity of the SOW, and urgency. Your first year's expenses will include everything, including initial license fees; all setup and training; any interfaces and additional configurations or customization; and first annual MSW. (If this isn't included in the SaaS subscription, then it usually commences on full system delivery). Afterwards, your subscription and MSW will be the only ongoing expenses (included as one in this example), unless you choose to have additional interfaces or other services performed at any time.
 
 
==5. Commercial vendors with public pricing==
Among many other functions, LIMSwiki hosts information about commercial LIMS vendors (that can be found on the internet) and their offerings. Sometimes public-facing pricing can be found for those vendors, and it's added to the vendor record. The following tables represent those vendors who make publicly available some form of pricing information that can thusly be cited. Should it be discovered that a vendor removed pricing, no longer makes it public (including putting it behind a registration wall), or had a public-facing contract with pricing expire (as with the U.S. General Services Adminstration or GSA), it will be removed from these vendor listings. See the description for each table for further details.
 
{{Commercial vendors with public pricing}}
 
 
==6. Additional resources and help==
===LIMSforum===
Formerly a LinkedIn-associated group, [https://www.limsforum.com/ LIMSforum] is a web portal for those interested in laboratory, scientific, and [[health informatics]].
 
===LIMSpec===
[[LII:LIMSpec 2022 R2|LIMSpec]] is a user requirements specification built upon more than 100 regulatory, standard-based, and guideline-based resources, with [[ASTM E1578-18]] ''Standard Guide for Laboratory Informatics'' and its own requirements list chief among them. LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained.
 
===LIMSwiki guides and research===
A variety of [[:Category:LII:Guides, white papers, and other publications|laboratory, scientific, and clinical informatics rsearch materials]] have been posted to LIMSwiki over the years.
 
===LIMSwiki FAQ articles===
A relatively new endeavor called "[[:Category:LIMS FAQ articles|LIMS FAQ]]" has been started on LIMSwiki. The general idea is to take one question related to an industry, lab type, standard, etc. and concisely answer it, in brief.
 
===LIMSwiki informatics resource portal===
[[LIMSWiki:Resources|The informatics resource portal]] here at LIMSwiki features a collection of as many useful online scientific and health informatics-related materials and research tools as possible, including books, journals, blogs, web portals, education programs, conferences, and more.


==References==
==References==
{{Reflist|colwidth=30em}}
<references />


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[[Category:Food and beverage industry|LIMS FAQ:What standards and regulations affect a food and beverage laboratory?]]
[[Category:LII:Guides, white papers, and other publications]]
[[Category:LIMS FAQ articles (added in 2022)]]
[[Category:LIMS FAQ articles (all)]]
[[Category:LIMS FAQ articles on food and beverage]]

Revision as of 19:55, 3 February 2023

Sandbox begins below

Lion Lab Technician2 (16279873861).jpg

This buyer's guide is based off the LIMS Buyer's Guide, a former publication of the Laboratory Informatics Institute (LII), an open trade association that was associated with LabLynx, Inc.[1][2] In late 2013, the LII and LabLynx discontinued publishing a copyrighted version and chose to release future guides to the public domain via this wiki. Per the Creative Commons license and the copyright terms of this site, you are free to copy, adapt, distribute, and transmit this guide as long as you 1. give proper attribution and 2. distribute the work only under the same or a similar license.


1. Introduction

What exactly is a laboratory information management system (LIMS) or laboratory information system (LIS) anyway? Do I need one? What options are available and how do I compare them? Where does a user requirements specification (USR), request for information (RFI), request for proposal (RFP), or request for quotation (RFQ) come into play, and how does it fit into acquiring a laboratory informatics solution? These are questions laboratory professionals typically ponder upon finding themselves charged with the mission of finding software for their lab. It can be a daunting proposition, and there are few at least partially objective references to help with it all. This brief guide exists to, in part, meet that need.

At the core of this buyer's guide are several elements, including core information about evaluating, acquiring, and implementing laboratory software that fits your lab's needs. Also included here are laboratory informatics vendors who actually make their pricing partially or fully public, through one means or another. That pricing may be fully transparent and posted on the company website, or it may be a partial representation of the lowest possible price offered, as with those vendors who have a publicly viewable contract with the U.S. General Services Administration. While in the past vendors have refrained from providing public pricing, a more open information process may have its merits (particularly for potential buyers), though also not without its own set of caveats.[3] The theory—at least on paper—has been that prices should decrease as LIMS become commodities that labs can compare and contrast in a more competitive fashion. However, it remains to be seen if that will ever be the case.

Laboratories are, by their very nature, in the business of producing analytical data and reports, essentially information.[4] Everything else that occurs in the laboratory is largely just a means towards that central goal of producing timely, accurate, and unbiased information. As such, in a very real sense, information management is, by extension, also at the core of any lab. In a world where we use the latest technology for most of our daily tasks and pleasures, why do so many labs still rely on hand-written notes and spreadsheets? Why do they still spend thousands of dollars on a sophisticated analytical instrument yet hesitate when faced with purchasing an information management system? The primary reason has traditionally been the cost associated with acquiring an informatics solution, as well as not having the information technology resources to properly implement it.[5][6][7]

Software solutions like LIMS are increasingly becoming commodities, and potential buyers don't need to find the acquisition process as daunting as it used to be. As technology has improved, smaller LIMS companies have emerged, along with affordable cloud-based SaaS options that are flexible and reliable. This means any lab can put their resources where they belong: into its analytical information and its management.

This brief buyer's guide is here to help you take the first steps towards acquiring a laboratory informatics solution. Use these vendor profiles and recommendations to get a feel for what's out there and what makes the most sense. This guide contains information on a little bit of everything, from discovering what a LIMS is to maintaining and supporting that system. While the LIMS is the stand-out solution among the crowd for laboratories, this guide may also reference other systems like a LIS or electronic laboratory notebook (ELN).


2. How does laboratory software benefit the lab?

Laboratory, scientific, and healthcare informatics solutions can improve laboratory workflows while enhancing safety, quality, and compliance in a number of ways. A LIMS, for example, is often adopted to eliminate manual processes, improve sample management, increase productivity, and improve regulatory conformance.[8] The adoption of LIMS and other such systems to eliminate deficiencies and improve operations is often based in the disadvantages of paper-based processes—particularly in regulatory environments—and their inability at making their contents rapidly findable, searchable, modifiable, and secure.[9][10]

Even a fragmented mix of paper-based and electronic information sources can be a detriment to the traceability of or rapid accessibility to quality control samples, standard operating procedures (SOPs), calibration data, chain of custody data, and other vital aspects of analytical, sampling, and calibration testing in the lab. A well-implemented LIMS can reduce the silos of data and information, while at the same time make that information and data more secure and readily accessible. Given the demands placed on laboratories—by ISO/IEC 17025 and clients seeking labs certified to that standard, for example—to provide rapid proof of traceable sample movement and relevant quality control data, integrating a LIMS into the laboratory makes sense. The LIMS can act as the central integrator and audit trail for all that laboratory data and information.[11][12][13] Because the LIMS improves traceability—including through its automated interfaces with instruments and other data systems—real-time monitoring of supply chain issues, quality control data, instrument use, and more is further enabled, particularly when paired with configurable dashboards and alert mechanisms. By extension, labs can more rapidly act on insights gained from those real-time dashboards.[11]

There is a growing variety of laboratory informatics software providing these and other benefits to labs, allowing them to more rapidly adapt and remain competitive. Arguably, the most common solutions are the LIMS and LIS. The LIMS and LIS are similar, in that they focus on the entire laboratory process and improving the various aspects of it. Traditionally, the LIMS has been used in more non-clinical environments and the LIS in more clinical environments, but that distinction has been fading for well over a decade. These distinctions have blurred even more with the age of modular and platformed software solutions that are able to adapt to most any industry. For now, just know that these systems are a bit more holistic, placing the focus on improving your lab's workflows, which in turn strengthens traceability, analytical outcomes, and—in the case of clinical settings—patient outcomes. Outside of that, there are other more specialized solutions, including:

  • the ELN, which is used in many research and development environments (among others) as a means to securely and collaboratively document experiments and their results;
  • the laboratory execution system (LES), which is used in production-based environments to ensure the rigidity of a method and and the process' end result;
  • the chromatography data system (CDS), which is used to accurately collect, process, and visualize chromatography data; and
  • the scientific data management system (SDMS), which is used to collect disparate silos of data and information across the laboratory enterprise and make it more actionable.}}

While these systems can be found in many types of labs, some tendencies appear. LIMS, LIS, and ELN are top-level solutions that help the lab manage workflows, as well as aggregate and organize data and information, including analytical- and experiment-based results. In services labs, the ELN is less likely to appear. However, in the case of research labs, the ELN may function more top-level, with the LIMS acting as a supplementary system for managing test workflows before associated test results are loaded into the ELN. Support systems like the LES, CDS, and SDMS may also appear, filling specialized roles. The LES will appear in more regulated environments where laboratory procedures must be executed precisely, before then feeding results to a LIMS or ELN. The CDS will appear in labs doing heavy chromatography work, and it too may feed data into a LIMS or ELN. The SDMS appears in contexts where data and information produced by the lab don't fit in the structure of what a LIMS or ELN handles.


3. How do I find the right solution for my needs?

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As indicated above, the type of solution you choose is based on your lab type (e.g., service, research, production), the tests predominately run (e.g., chromatography work, requiring a CDS), and the type of data and information generated and stored (e.g., non-standard files, requiring an SDMS). However, finding the right system to fit your labs needs isn't a straightforward process. While your lab may know its regulatory-, workflow-, and standard-driven requirements, perhaps critical personnel don't know much about data management solutions like LIMS, leaving a lab's key stakeholders intimidated by all the options. You'll first need to gauge your lab's informatics needs in order to determine which products are worth investigating further. Of course your lab's analysis requirements, reporting and data sharing constraints, instrument interfacing needs, barcoding and tracking requirements, quality assurance processes, etc. are certainly important factors. But vendors' systems vary in numerous ways, and other important factors exist. Of course, price is one consideration, although value is ultimately more important than a low price. Other important questions that get asked include:

  • Should we purchase software licenses or "rent" the software via a subscription-based model?
  • Does the software need to be on-site, or is a SaaS hosted option more practical?
  • Is a modular or complete system better for us?
  • What is the best licensing/rental scheme for us? Should we consider site, named user, concurrent user, or workstation licenses?
  • Is the company qualified and trustworthy?
  • What functionality is available to help our lab remain compliant with the a variety of standards and regulations?

3.1 Technology considerations

Your laboratory's workflow, instruments, data management requirements, budget, technological expertise, business goals, and risk tolerances will all play a role in deciding what technology to invest in. Your lab will also be interested in how that technology not only helps with workflow requirements but also better assists the lab with meeting the requirements placed upon them by various standards and regulations, as well as management.

As part of this discovery process, many questions may arise. Chief among them may be how to best match the laboratory's goals with one or more informatics solutions. Does the laboratory envision a small investment and modest goals, taking in a slow but steady flow of analytical requests, or do they envision expansive growth, expanding into multiple testing domains? If the lab is starting small but is confidently expecting to grow, technological investments early on may want to take into account future technologies that may shape data management and security processes. The lab will also want to account for how potential changes in standards and regulations may affect future expansion and technology needs.

Second, ask what kind of work will the lab be doing, and what regulatory responsibilities will guide hardware and software investment at the lab. If your lab will be conducting extractable and leachable testing, you'll be considering chromatography and spectroscopy instruments and software systems, as well as requirements for retaining analytical results for regulators. Those labs accredited to standards such as ISO/IEC 17025 will have additional needs for instruments and software systems; such labs' data management system will likely need to be sufficiently robust to meet the needs of the standard. For those labs in more regulated spaces, the system will even need to interface to government systems, or at a minimum report in the regulatory body's specific format. These and other considerations will need to be made.

Third, your laboratory's budget is always important. Does the budget allow for on-site hardware and software systems, with the personnel to maintain them? Is it easier to pay up-front or find a vendor willing to work with you on leasing or rental terms? Is their more value to be had from a slightly more expensive system able to provide the functionality that makes regulatory compliance more painless for the lab?

Finally, will the lab have someone on-site or on-call to resolve technology issues, including set-up and maintenance of software systems? If your lab will have little in the way of available tech help locally, you'll want to consider the distribution model you want to use for any installed software, i.e., you may want to consider software as a service (SaaS). An increasing number of software services are hosted using cloud computing, which when done well is an increasingly reliable option.[14] Having someone else host the software for you typically means the hosting provider will carry a non-trivial portion of responsibility for technology maintenance and security.

Speaking of security, you'll also want to consider the cybersecurity of not only your software solution but also your overall laboratory operations. Does your organization have a cybersecurity plan already in place, or has the decision to make one been postponed? What extra investment is required to ensure your sensitive data is secure? How do your cybersecurity goals compare to the demands of standards like ISO/IEC 17025? Remember that how you rank your cybersecurity preparedness and implement a cybersecurity plan will also guide your technology investment decisions.[15]

3.2 Functionality considerations

Technology aside, the lab will also want to consider the functionality of the various laboratory informatics solutions offered by vendors. Some laboratorians may already be familiar with the LIMS or ELN and understand what it is capable of doing for the lab. However, others may have little familiarity with such systems and have only vague concepts of how they function. Either way, it's useful for the lab to gain a clearer understanding of what such solutions can do. There are several ways to go about this, from reading through examples of user requirements documents to participating in demonstrations of software from various vendors. In fact, both methods remain useful, and a standard approach to acquisition will usually include both. In the end, the question for any prospective vendor to answer is "how can your solution meet our laboratory's requirements?" This is where functionality comes in.

The follow sections will look at functionality considerations first by introducing the user requirements specification (URS) as a means of learning more about system functionality. From there we'll look specifically at a LIMS and what its core and ancillary features look like, before finally re-addressing the URS from the perspective of how it can be implemented to full effect.

3.2.1 The user requirements specification as a functionality guide

A specification is "a detailed precise presentation of something or of a plan or proposal for something."[16] This concept of a specification as a presentation is critical to the laboratory seeking to find laboratory informatics software that fulfills their needs; they "present" their use case with the help of a requirements specification, and the vendor "presents" their ability (or inability) to comply through documentation and demonstration. However, even the most seasoned of presenters at conferences and the like still require quality preparation before the presentation. Similarly, your lab has work to do beforehand. This is where initial specification research comes into play for the lab.

Your lab's requirements specification document will eventually be a critical component for effectively selecting a laboratory informatics solution. For those labs with limited knowledge of what such a solution is capable of doing, building a URS can be especially useful. There are numerous ways to approach the overall development of a URS. But why re-invent the wheel when others have already gone down that road? Sure, you could search for examples of such documents on the internet and customize them to your needs, or you and your team could brainstorm how a laboratory informatics solution should help your lab accomplish its goals. Or you could turn to a robust URS like LIMSpec 2022.

LIMSpec is a robust laboratory informatics requirements specification document that has evolved significantly over the years, and any lab can turn to LIMSpec to better visualize what the critical requirements of a LIMS (or other laboratory informatics solution) are. With the current version of LIMSpec having at its core standards such as ASTM E1578-18 Standard Guide for Laboratory Informatics[17] and ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories[18], the LIMSpec makes for a durable URS that, when used to acquire an informatics solution, can better help a laboratory choose appropriate functionality based upon current standards, regulations, guidance, and more.

LIMSpec is divided into five distinct sections, with numerous subsections in each. These sections and subsections should be able to address most any requirement you have for your system. Of course, if something isn't covered by LIMSpec, you can always add additional requirements. More importantly, if you have little concept of what functionality systems such as a LIMS or SDMS should have, reviewing this URS can give you a leg up, as can participating in vendor demonstrations. Of course, the base LIMSpec can be used to develop your lab's custom URS to present to potential vendors. (More on that in a bit.)

3.2.2 Core functions and features

While laboratory, scientific, and clinical informatics vendors may provide a similar core set of functionality in their solutions, there's still a lot of room for variance. Some vendors may try to make a one-size-fits-all solution, while others may focus on certain specialties or uses. In the end, despite the different approaches, a certain set of core functionality becomes apparent. This guide will focus on the LIMS/LIS and its functionality. You should expect the following functionality to be demonstrated in a mature and professional LIMS/LIS offering:

Test, experiment, and entity management

  • sample/specimen log-in and management, with support for unique IDs
  • batching support
  • barcode and RFID support
  • sample/specimen tracking
  • pre-defined and configurable industry-specific test and method management
  • pre-defined and configurable industry-specific workflows
  • clinical decision support (for clinical)
  • event and instrument scheduling
  • templates, forms, and data fields that are configurable
  • analytical tools, including data visualization, trend analysis, and data mining features
  • data import and export
  • robust query tools
  • document and image management, with support for unique document numbers
  • project and experiment management
  • case management (for clinical and forensic)
  • supplier/vendor/customer/patient management
  • storage management and monitoring


Quality, security, and compliance

  • quality assurance / quality control mechanisms
  • changed, amended, or re-issued report management
  • data normalization and validation
  • results review and approval
  • trend and control charting for statistical analysis and measurement of uncertainty
  • version control
  • user qualification, performance, and training management
  • audit trails and chain of custody support
  • configurable and granular role-based security
  • configurable system access and use (log-in requirements, account usage rules, account locking, etc.)
  • electronic signature support
  • configurable alarms and alerts
  • data encryption and secure communication protocols
  • data archiving and retention support
  • configurable data backups
  • environmental monitoring and control
  • incident and non-conformance notification, tracking, and management
  • instrument lock-out


Operations management and reporting

  • configurable dashboards
  • customizable rich-text reporting, with multiple supported output formats
  • custom and industry-specific reporting, including certificates of analysis (CoAs)
  • synoptic reporting (for clinical)
  • industry-compliant labeling
  • email integration
  • internal messaging system
  • revenue management
  • instrument interfacing and data management
  • instrument calibration and maintenance tracking
  • inventory and reagent management
  • third-party software and database interfacing
  • data import and export
  • mobile device support
  • voice recognition capability
  • results portal for external parties
  • integrated (or online) system help
  • configurable language

3.2.3 Additional useful features

The following features are examples of additional LIMS/LIS functionality beyond the core functions a laboratory may seek (it is not meant to be a complete list):

  • audit management
  • clinical research support
  • complaint management
  • customer relationship management
  • electronic laboratory notebook support
  • ERP and accounting interfaces
  • inventory reconciliation
  • invoicing and quotation support
  • product specification management
  • project management
  • recipe management
  • reflex testing support
  • safety tracking and compliance
  • single sign-on support
  • stability testing management

3.3 System flexibility

Laboratorio de Paleoetnobotánica y Paleoambiente, área de microscopia.jpg

Before selecting a solution, your laboratory should also have internal discussions about how diversified its offered services are, as well as what the future may bring to the lab. If, for example, your lab is currently configured for one type of testing, does your existing laboratory informatics system—or the ones you may be considering—have the flexibility to add other types of testing, protocols, and workflows? Will you be doing the footwork to add them, or will the vendor of your system support you in that effort? If you're a start-up, will your lab be focusing solely on a specific type of testing and expand into other types of analytical work later, or will your test menu need to be much broader right from the start? In most of these cases, you'll desire software that is flexible enough to allow for not only running the specific tests you need now, but also sufficiently expandable for any future testing services your lab may conduct in the mid- and long-term. Having the ability to create and customize sample registration screens, test protocols, labels, reports, specification limit sets, measurement units, and substrates/matrices while being able to interface with practically most any instrument and software system required will go a long way towards making your expanding test menu and workflows integrates as smoothly as possible.

Such a system will typically be marketed as being highly user-configurable, giving labs a relatively painless means to adapt to rapid changes in test volume and type over time. However, once you've internally addressed current and anticipated future growth, your lab will want to learn what explicitly makes any given vendor's system user-configurable. How easy is it to configure the system to new tests? Add custom reports? What knowledge or skills will be required of your lab in order to make the necessary changes, i.e., will your staff require programming skills, or are the administrator and advanced user functions robust enough to make changes without hard-coding? These and other such questions should be fully addressed by the vendor in order to set your mind at ease towards a system's stated flexibility. Ultimately, you want the system to be flexible enough to change with the laboratory—and industry—itself, while minimizing overall costs and reducing the time required to make any necessary modifications.

3.4 Regulatory compliance considerations

When considering their laboratory informatics solutions, labs will also want to take regulatory- and standard-based compliance into consideration. In regards to regulatory compliance in particular, it may be helpful to approach the topic from the standpoint of adopting standards. Consider first that the risks and consequences of performing a task poorly drives regulation and, more preferably[19][20], standardization, which in turn moves the "goalposts" of quality and security among organizations. In the case of regulations, those organization that get caught not conforming to the necessary regulations tend to suffer negative consequences, providing some incentive for them to improve organizational processes and procedures.

One of the downsides of regulations is that they can at times be "imprecise" or "disconnected"[20] from what actually occurs within the organization and its information systems. Rather than focusing heavily on regulatory conformance, well-designed standards may, when adopted, provide a clearer path of opportunity for organizations to improve their operational culture and outcomes, particularly since standards are usually developed with a broader consensus of interested individuals with expertise in a given field.[19] In turn, the organizations that adopt well-designed standards (e.g., ISO/IEC 17025) likely have a better chance of conforming to the regulations they must, and they'll likely have more interest in maintaining and improving the goalposts of quality and security in the lab.

Additionally, reputable software developers of laboratory informatics software will not only adopt their own industry standards for software development but also understand how regulations, standards, and LIMS requirements intersect. Given that understanding, the developed software should meet regulations and standards, help the laboratory comply with its regulations and standards, and be of reliably good quality.

If you're a potential buyer of a laboratory informatics solution, it may be that you know a bit about your laboratory's workflow and have at least a remedial understanding of how certain regulations and standards influence how that workflow is conducted, but you're not entirely informed about all the details of how a LIMS can help your lab better conform. Turning to a URS such as LIMSpec—which was developed around laboratory regulations and standards, including ISO/IEC 17025—and reviewing the various statements contained within may be necessary to help further inform you. Additionally, as you investigate various informatics options, you can then use the requirements in the URS as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the base URS. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query. And since your URS is based off the standards and regulations affecting your lab, you can feel more confident in your acquisition and its integration into your laboratory workflow.

3.5 Putting a URS to work for your lab

As stated prior, building a URS specific to your lab can easily start by examining an existing URS like LIMSpec, which covers most functionality a laboratory could need out of their informatics solution. However, LIMSpec is extensive in what it covers. During the initial research put towards your URS, know that you likely don't want to send the full, comprehensive URS to vendors, at least not in the initial discovery stages. Most vendors appreciate a more inviting approach that doesn't initially overwhelm. Early on you're better off to go with a limited yet practical set of requirements carefully chosen because they matter to you and your laboratory the most. For a food and beverage laboratory, support for molecular biology workflows, stability studies, and production management could be critical. In the case of a lab seeking a solution to help them better comply with ISO/IEC 17025, the lab might want to focus on requirements related to complying with the standard.

However you choose to approach URS development and presentation, you'll likely want to wait until after participating in several vendors' software demonstrations before even considering your URS to be complete. The demo offers a unique and valuable opportunity to see in-person how data and information is added, edited, deleted, tracked, and protected within the context of the application; you can ask about how a function works and see it right then and there. Equally, it is an excellent time to compare notes with the vendor, particularly in regard to requirements your lab deems being critical. You can ask the vendor in real-time to answer questions about how a specific task is achieved, or how the system addresses specialized needs, and the vendor can ask you about your lab's system and workflow requirements and how you best envision them being implemented in the system.

Again, be careful about falling for the temptation of presenting a full URS or other specification document to the vendor during the demonstration. You'll want to wait until after participating in several software demonstrations to consider presenting your full specification document to the vendor, and that's assuming that you've grown enamored with their solution. By waiting to finalize your lab's URS until after the demos, a common error is avoided: too often labs think the first thing they must do is create a requirements list, then sit back and let the informatics vendors tell them how they meet it. Remember that even though most labs thoroughly understand their processes, they likely don't have as strong a grasp on the informatics portion of their processes and workflows. Participating in a demo before finalizing your list of specified requirements—or having only a minimal yet flexible requirements list during the demo—is a great way to later crosscheck the software features you have seen demonstrated to your lab's processes and any initial requirements specification you've made.[21] After all, how can you effectively require specific functions of your laboratory informatics software if you don't fully know what such a system is capable of? After the demonstrations, you may end up adding several requirements to your final specifications document, which you later pass on to your potential vendors of choice for final confirmation.

In some cases, rather than approaching vendors, a lab may want to take a different exploratory route by issuing a request for information (RFI) or something similar. An RFI is an ideal means for learning more about a potential solution and how it can solve your problems, or for when you're not even sure how to solve your problem yet. However, like when approaching a vendor directly, the RFI should not be unduly long and tedious to complete for prospective vendors; it should be concise, direct, and honest. This means not only presenting a clear and humble vision of your own organization and its goals, but also asking just the right amount of questions to allow potential vendors to demonstrate their expertise and provide a clearer picture of who they are. Some take a technical approach to an RFI, using dense language and complicated spreadsheets for fact finding. However, as previously noted, you will want to limit the specified requirements in your RFI to those carefully chosen because they matter to you and your lab the most.[22]

Remember, an RFI is not meant to answer all of your questions. The RFI is meant as a means to help narrow down your search to a few quality candidates offering functionality that meets your needs, while also learning more about each other.[22] Once the pool of potential software vendors is narrowed down, and you then participate in their demonstrations, you then can broadly add more requirements to the original collection of critical requirements from the RFI to ensure those vendors can meet all or most of your needs. That said, be cognizant that there may be no vendor that can meet each and every need of your lab. Your lab will have to make important decisions about which requirements are non-negotiable and which are more flexible. The vendors you engage with may be able to provide realistic advice in this regard, based upon your lab's requirements and their past experience with labs. As such, those vendors with real-world experience meeting the needs of laboratories like your may have a strong leg up on other vendors.

Ultimately, your URS may look similar to LIMSpec, or it may have a slightly different format. Many prospective buyers will develop a requirement specification in Microsoft Excel, but that has a few minor disadvantages. Regardless of format, you'll want to give plenty of space for vendors to submit a response to each requirement. With a more complete URS in hand, and your vendor list narrowed down to a few possibilities, you're ready to submit the full URS to those vendors. Other considerations come into play afterwards, depending how those vendors' respond to you URS. How well did the vendors respond to your laboratory's unique set of needs? Were there critical areas that one vendor could address with their off-the-shelf solution but another vendor would have to address with custom coding? Did any of the vendors meet your budget expectations? Have you followed up on any references and customer experiences the vendors provided to you?


4. What other considerations should I make, and how much will it cost?

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Hopefully, once all the due diligence is done, and with a little luck, you've found a vendor that fits your technology and functionality needs, even if a few minor compromises had to be made along the way. However, there's obviously more than technology and system functionality to consider! What are some implementation considerations? How is the vendor's solution offered: in the cloud or locally? What kind of licensing is used? What are the specifics of the maintenance, warranty, and support plans? And of course, what sort of cost (better to think of it in terms of "investment") is involved? This next section addresses these questions and more.

4.1 Implementation

If you've ever worked through a system implementation process with a vendor, it was hopefully a smooth process. However, there are plenty of horror stories out there, highlighting the need of the laboratory to discuss in detail how a potential vendor will handle installation, validation, and training for the informatics solution. Does the vendor truly understand the industry and your needs? Does the vendor assign a project manager who will work with you, from planning to go-live and beyond? Can they offer you references of other labs who have gone through implementation so you can compare notes with those labs? How much attention does the potential vendor give to related issues such as data integrity of migrated data? Do they have the means to properly handle your legacy data? And are they able to work with your schedule, even if it means implementing software at off-peak work hours?[23][24]

As you finally get down to the ultimate decision on which vendor to work with, you may wish to start setting up an implementation checklist as part of your early project planning. Do you receive a help desk account as part of the implementation process, and if so, what information is included? If not, you'll need to keep track of specific details such as business associate agreement (BAA), sales agreement, scope documents, welcome letters, documentation, and approved staff who can utilize the vendor's support. You'll likely need to share other configuration details with the vendor, including time zone requirements, DNS and URL requirements, up-time monitors, and administrative account requirements. Finally, you'll want to ensure you and the vendor are on the same page concerning any additional customization, integration, and system validation requirements, ensuring the roll-out period is pain-free and efficient.

4.1.1 Internal and external integrations

Laboratories acquire data management software for many reasons, including improving accuracy and quality, saving time, increasing productivity, and adding capabilities. One way of doing all of those activities is to integrate or interface your systems, databases, and instruments so that human error is greatly reduced or eliminated, workflows are automated and sped up, and each component's capabilities are brought into play in the most efficient and effective ways possible. As such, you'll want to inquire with the vendor about its solution's hardware and software integration capabilities. Is it designed to interface with every laboratory instrument or software that can output any readable electronic file? Or are integrations limited to certain instruments and systems? How does it connect, i.e., what protocols does the software depend on to connect with other systems? Does the system allow a user to map their own file imports and exports? Can system processes be set to detect new instances of file outputs at regular intervals? Ask these and other questions to make sure the vendor clearly describes what internal and external integrations are supported with their application.

In many cases, a vendor's LIMS solution will have instrument integration capability built into the software, but occasionally such interfaces are separate from the main software. Today's instrument interfaces are generally built on standardized communication protocols such as RS-232, RS-422, IEEE-488 (GPIB), USB, Ethernet, and more.[25] The LIMS that can support such instrument integrations is increasingly vital to the ISO/IEC 17025 laboratory. Such labs may also want their laboratory informatics solution to be able to communicate with other software and databases. This is often done using application programming interfaces (APIs) that depend on web services implementation protocols such as REST and SOAP.[26][27][28] These messaging protocols actually allow for the creation of an API that receives communication requests and sends responses between two software systems. A more practical example is wanting your laboratory informatics solution to communicate with an enterprise resource planning (ERP) application or a QMS. Perhaps rather than housing quality management documents exclusively in the LIMS, the lab has had a dedicated electronic QMS for years, and they'd like to be able to interface that with the LIMS. APIs and communication protocols make this happen.[27]

4.2 MSW, updates, and other contracted services

The maintenance, support, and warranty (MSW) offered with the vendor's solution is almost as important as the solution itself. The laboratory informatics solution you acquire is more than than the software you operate: it's mission-critical and deserves having a reliable and responsive team with the necessary resources to ensure it remains operational. Downtime can negatively affect both immediate customer satisfaction and your reputation. As such, it's imperative you ask the vendor about the details of its MSW, making sure you understand what is and isn't covered, as well as how much it will cost (discussed in the next section). Cost-wise, industry norms are anywhere from 15% to 25% of either the license fee or total contract, levied annually to provide this coverage.[29] Alternatively, it may simply be included with your subscription. The MSW will include a specified number of support and maintenance hours or guarantees. The actual warranty should be unlimited for as long as the MSW or subscription is kept current.

Maintenance includes any and all work necessary to keep your system working as designed. It should include updates, patches, or fixes, and most if not all upgrades. (Note, however, a major upgrade to a totally new edition may not be covered, but it may come at a negotiable, significantly lower cost.[30]) The support aspect of MSW generally consists of a specified number of hours dedicated more to helping you with the operation of the system rather than "fixing" anything. Support includes guidance on training, password or login support, and more. Finally, with any professional application you also expect to have a warranty. The warranty should cover anything that doesn't work that otherwise should for the designated period of time.[30] That includes any standard features and functions, as well as any additional ones that were delivered and signed off on, and any other work performed by the vendor or its representatives. However, a typical warranty does not cover anything that was working fine, but upon being manipulated in a way beyond normal operation the functionality ceased. In these cases, you'll probably have to pay to get it fixed.

Beyond the MSW, additional updates and services related to the system may also be required. No matter how well it is pre-configured, any professional laboratory informatics solution will require some amount of standard setup to reflect your particular lab. This includes adding lab branding and demographics for reports and certificates; entering users, their roles, and access permissions; adding and/or modifying tests and workflows; renaming fields; adding or hiding fields; setting up a web portal; and implementing interfaces. Equally indispensable is proper training for both users and administrators. And of course you may later find that you would like additional features or functions. These and other services may prove particularly useful to the laboratory with little in the way of IT and systems expertise. As such, the vendor may provide one or more of the following as a billable service for the laboratory:

  • initial implementation meeting (e.g., initial planning, identify delta, set schedule)
  • project management
  • requirements gathering and documentation
  • initial setup
  • user and administrator training
  • configuration and customization
  • interface development and implementation
  • custom screen and field development
  • custom functionality development
  • custom reports and labels
  • custom triggers and alerts
  • validation or acceptance testing (to a third-party standard or certification, or to agreed manufacturer specs)

4.3 Cost considerations

Dollar symbol.jpg

First, you'll want to be clear on what will be included in the sales agreement. Whether through an estimate or statement of work (SOW), it is important it includes exactly what is expected, being as specific as possible, since this will be the entire contractual obligation for both you the buyer and them the vendor. Note that line items may differ slightly from system to system, according to what features and functions are included by default with each vendor's solution and which, if any, are additional. Also keep in mind that any hourly amount in the the estimate or SOW is usually a best estimate; however, if sufficient attention to detailed requirements has been given, then it should be quite accurate, and in fact the final cost may even be below the quoted cost if you prioritize your own obligations so that the vendor's hours are used sparingly and efficiently.

The estimate or SOW should optimally include:

  • licensing or subscription rates;
  • required core items to meet federal, state, and local regulations;
  • additional optional items and totals; and
  • required services (implementation, maintenance and support, optional add-ons).

There are two primary ways to price a laboratory informatics solution: a one-time license fee or a subscription rate (cloud-hosted SaaS). If you have your own dedicated IT department and staff, you may prefer the former (although many system administrators are just as happy to let it be hosted elsewhere rather than add to their workload). Otherwise, a SaaS subscription may well be the better and more cost-effective way to go (since the primary IT cost is simply internet access). This item will be part of your up-front cost and, in the case of subscription, it will also figure into your first year and ongoing costs; otherwise only associated MSW will figure in. Typically, your first year's subscription costs will be due at signing. More often, the vendor may require three months or even the first year up front, so be prepared to factor that into up-front costs. However, it still is almost always less expensive at the outset (and over time, if you factor in IT costs and annual MSW) than paying for a license fee.

In addition to the two types of software pricing, there are also sub-types. Generally these are based on the number of users (or, in some cases, "nodes," which are simply any entities that access the informatics system, including other systems, instruments, etc.). How these are counted can vary.

  • Named users: This method bases pricing on the actual individual users of the system, even if they only log in sporadically. Users may not use each other's logins (this is a no-no regardless of pricing structure, for good laboratory practice and other regulatory reasons).
  • Concurrent users: This bases pricing on the maximum number of users who will be logged in at any given time. You can define an unlimited number of named users in the system, each with their own login credentials. However, only the number of concurrent users specified in the license or subscription may be logged in at any one time. For example, you may have 10 staff, but due to work processes, shifts, etc., only up to six might ever be logged in simultaneously. Whereas this would require a named user license for 10, it would only require a concurrent user license for six.
  • Unlimited users: In the case of very large labs (typically 30 to 50 and up), the license or subscription may simply be a flat fee that allows any number of users.

The line items in the estimate or SOW should reflect these nuances, as well as whether the listed costs are monthly or annual (for subscription services), hourly (typically for support and training), or a fixed one-time cost. Additionally, be cautious with fixed costs, as they typically represent one of two possible scenarios:

  1. Final fixed cost: In this case, the cost has been figured by the vendor so as to cover their worst-case hourly labor total. If a line item (e.g., an interface) is not "worst case," then you are overpaying.
  2. "Expandable" fixed cost: This is as bad as final fixed cost, and maybe even worse because it's almost a case of "bait-and-switch," popping up as a surprise. The initial "fixed cost" number is low, and additional hourly services are needed to actually deliver the item. This will have been provided for somewhere in the small print.

The bottom line is that everything in a laboratory informatics solution is really either licensing or hourly services. Just be careful if they are portrayed as anything else.

It is important to be clear which category each line item falls under when figuring costs: up-front (due upon signing), annual, or ongoing (e.g., SaaS subscription). It is useful to clearly lay out each and compute initial costs, as well as first-year and subsequent years' costings. For example, your initial obligation may be as little as your first year's subscription plus the first 40 hours of services. Different vendors have different policies, however, and you may be required to pay for your first full year's subscription and all services, or some other combination. Normally, though, any instrument interface or other service charges aren't due until the they are implemented, which may be a few weeks or even a month down the road. This may depend on your budget, complexity of the SOW, and urgency. Your first year's expenses will include everything, including initial license fees; all setup and training; any interfaces and additional configurations or customization; and first annual MSW. (If this isn't included in the SaaS subscription, then it usually commences on full system delivery). Afterwards, your subscription and MSW will be the only ongoing expenses (included as one in this example), unless you choose to have additional interfaces or other services performed at any time.


5. Commercial vendors with public pricing

Among many other functions, LIMSwiki hosts information about commercial LIMS vendors (that can be found on the internet) and their offerings. Sometimes public-facing pricing can be found for those vendors, and it's added to the vendor record. The following tables represent those vendors who make publicly available some form of pricing information that can thusly be cited. Should it be discovered that a vendor removed pricing, no longer makes it public (including putting it behind a registration wall), or had a public-facing contract with pricing expire (as with the U.S. General Services Adminstration or GSA), it will be removed from these vendor listings. See the description for each table for further details.

To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.

 


Website and submitted pricing

These vendors either post most of their pricing information for their solutions on their website or have submitted their pricing to the wiki admin directly. In all cases, be sure to contact the vendor to verify pricing, as it may change with little notice. Vendors are sorted by number of public videos demonstrating how their products work.

Vendor Pricing Has cloud or
SaaS offering?
# of demo
videos
LIMS? LIS? ELN? CDS
and/or
SDMS?
Additional notes
Research Innovations Limited Link Yes 90+ No No Yes No
LabKey Corporation Link Yes 86 Yes No Yes Yes
Biomatters Ltd. Link No 68 Yes No No No
Creliant Software Pvt. Ltd. Link Yes 60 No Yes No No
LabArchives, LLC Link Yes 56 No No Yes No All but Enterprise pricing listed.
Labii, Inc. Link Yes 56 Yes No Yes No Product is combination LIMS and ELN
SLCLAB Informática SL Link Yes 38 Yes Yes No No
Labstep Ltd. Link Yes 28 No No Yes No
Terra Systems OÜ Link No 17 No Yes No No Pricing only available for MiniLIS, not other products.
MEDEORA GmbH Link Yes 16 Yes No No No
HealthScion Technologies Pvt. Ltd. Link Yes 15 Yes No No No LIMS is part of a larger overall platform.
LabLynx, Inc. Link Yes 15 Yes Yes Yes Yes Pricing supplied directly by company.
Labforward GmbH Link Yes 14 No No Yes No
Mestrelab Research S.L. Link Yes 14 No No Yes No
Autoscribe Informatics, Inc. Link Yes 13 Yes No No No Pricing supplied directly by company.
CloudLIMS.com, LLC Link Yes 11 Yes No No No
AgileBio Link No 9 Yes No Yes No
INTEGRIS LIMS GmbH Link No 9 Yes No No No Pricing available for "Small lab solution"; videos in German
Aiderbotics Corporation Link No 7 No No Yes No
WebPathLab, Inc. Link Yes 6 No Yes No No Pay-per-report pricing made public
Forney, LP Link Yes 4 Yes No No No
LabSmart Healthcare Technologies Link Yes 4 No Yes No No
Simploud Limited Link No 4 Yes No No No
Mci IT Pty. Ltd. Link Yes 3 Yes No No No
The Edge Software Consultancy Ltd. Link Yes 3 Yes No Yes No
Third Wave Analytics, Inc. Link Yes 3 Yes No No No
BioInfoRx, Inc. Link Yes 2 Yes No No No
Biomed Systems Ltd. Link Yes 2 Yes No No No LIMS available with ELN as add-on.
Broughton Software Ltd. Link Yes 2 Yes No No No Pricing supplied directly by company.
ML Consulting Technologies, LLC Link Yes 2 Yes No No No Free quality control LIMS for small laboratories
Revol Software Solutions, LLC Link Yes 2 Yes No No No
AINZ Corp. Link Yes 1 Yes No No No Former product was PharmWare.
Blaze Systems Corporation Link No 1 Yes No No No Pricing supplied directly by company.
Bureau Conseils et Services SCRL Link Yes 1 Yes No No No Starting prices listed
Bytewize AB Link Yes 1 Yes No No No Pricing only available for O3 LimsXpress.
TeselaGen Biotechnology, Inc. Link Yes 1 Yes No No No Pricing only available for Community and Starter editions.
Apex HealthWare, LLC Link Yes 0 No Yes No No Pricing only available for cloud-based POL version.
BiochemLab Solutions Link No 0 No No Yes No Free ad-based and paid ad-free versions of ELN exist.
ChemBytes Link No 0 No No Yes No Its successor to its free basic Espresso ELN will be Phoenix ELN,
yet to be released as free, open-source software.
Dorays Technologies Pvt. Ltd. Link Yes 0 No Yes No No
General LIMS, Inc. Link No 0 Yes No No No
Genetic Technologies, Inc. Link No 0 Yes No No No
J Street Technology, Inc. Link No 0 Yes No No No
LabLite, LLC Link No 0 Yes No No No Pricing supplied directly by company.
Labstudio (Pty) Ltd. Link Yes 0 Yes No No No
Microcline Projects Link Yes 0 Yes No No No
Minerva Data Link Yes 0 No Yes No No
Progeny Genetics, LLC Link Yes 0 Yes No No No
Wolfe Information Systems, Inc. Link No 0 Yes No No No

Free, minimally featured version, but no other public pricing

These vendors provide minimal pricing information, stating they have a free, minimally featured version of their software but not revealing any other pricing information for other versions of the same software. These are usually vendors offering a tiered solution, with the lowest tier being the free tier. Vendors are sorted by number of public videos demonstrating how their products work.

Vendor Pricing Has cloud or
SaaS offering?
# of demo
videos
LIMS? LIS? ELN? CDS
and/or
SDMS?
Additional notes
Benchling, Inc. Link Yes 36 No No Yes No Academic pricing is free, but rest of pricing was removed.
LabSpace, LLC Link Yes 0 No No Yes No Academic pricing is free, but rest of pricing was removed.

GSA pricing

These are vendors who have a publically viewable contract with the U.S. General Services Administration (GSA), and that contract displays prices for their solutions. As these are GSA prices, be aware they represent the lowest possible negotiated price. These prices aren't available to any entity outside of the Federal Government, and thus prices for non-government entities will be higher. If anything, they represent the lowest possible negotiated price. Vendors are sorted by number of public videos demonstrating how their products work.

Vendor Pricing Has cloud or
SaaS offering?
# of demo
videos
LIMS? LIS? ELN? CDS
and/or
SDMS?
Additional notes
Vendor:Waters Corporation Link No 33 Yes No Yes Yes
LabLynx, Inc. Link Yes 15 Yes Yes Yes Yes
STARLIMS Corporation Link Yes 8 Yes No Yes Yes
Vendor:LabVantage Solutions, Inc. Link Yes 6 Yes No Yes No
LabWare, Inc. Link Yes 6 Yes Yes Yes No
Promium, LLC Link Yes 2 Yes No No No
Xybion Corporation Link Yes 2 Yes No No No
Bentley Systems, Inc. Link No 0 Yes No No No
JusticeTrax, Inc. Link No 0 Yes No No No


6. Additional resources and help

LIMSforum

Formerly a LinkedIn-associated group, LIMSforum is a web portal for those interested in laboratory, scientific, and health informatics.

LIMSpec

LIMSpec is a user requirements specification built upon more than 100 regulatory, standard-based, and guideline-based resources, with ASTM E1578-18 Standard Guide for Laboratory Informatics and its own requirements list chief among them. LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained.

LIMSwiki guides and research

A variety of laboratory, scientific, and clinical informatics rsearch materials have been posted to LIMSwiki over the years.

LIMSwiki FAQ articles

A relatively new endeavor called "LIMS FAQ" has been started on LIMSwiki. The general idea is to take one question related to an industry, lab type, standard, etc. and concisely answer it, in brief.

LIMSwiki informatics resource portal

The informatics resource portal here at LIMSwiki features a collection of as many useful online scientific and health informatics-related materials and research tools as possible, including books, journals, blogs, web portals, education programs, conferences, and more.

References

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