Book:LIMS Selection Guide for Food Safety and Quality/Choosing laboratory informatics software for your food and beverage lab/Evaluation and selection

From LIMSWiki
Jump to navigationJump to search
-----Return to the beginning of this guide-----

3. Choosing laboratory informatics software for your food and beverage lab

FDA Center for Food Safety & Applied Nutrition (CFSAN) 6536.jpg

Computers in the laboratory are not a recent phenomenon. The mid-1960s saw laboratory computerization become increasingly popular[1][2][3][4][5], though that enthusiasm was often based on the potential of the computers themselves rather than their actual capabilities.[1] Laboratorians imagined potentials such as automatic sample label generation, daily log and report management, instrument interfacing and data processing, results comparisons, and time management tools. However, it would take time for some of those potentials to be realized.[1]

In 1970, Temple University's Marion Ball, M.A., an assistant professor in the Department of Medical Physics, conducted a survey of pathology directors in clinical laboratories that were using computers. Asking their opinions about the advantages and disadvantages of computerized systems in the lab, she received responses from directors in 15 U.S. states, as well as from three other countries. Responses included[6]:

The ability to rapidly prepare cumulative records and then to inspect them for possible errors through analysis trends has been proven to be of tremendous advantage in a number of laboratories. We can prevent errors in our analytical systems, but we are not prepared to prevent errors in the collecting of the sample, the mislabeling of the sample, or the accidental use of an incorrect sample. Thus, the ability to inspect data trends presents the only real tool that we currently have to pick out these kinds of errors. - Max E. Chilcote, Ph.D, Meyer Memorial Hospital Division

There is little argument about whether an operating computer system can be an advantage in a laboratory, but the most critical time is the installation and transition from a "manual" to a "computer" oriented laboratory. - Robert L. Habig, Duke University Medical Center

Reading about these potentials and opinions today, some 50 years later, we see both clear similarities and definite advances. For example, Habig's statement about transitioning from manual to more automated processes still rings true today: it can be nerve wracking and critical to get the transition right. Conversely, while the systems of decades past weren't able to "prevent errors in the collecting of the sample, the mislabeling of the sample, or the accidental use of an incorrect sample," modern laboratory informatics systems provide many assurances to sample management in the lab. In many cases, activities such as label generation, reporting, results analysis, workflow control, test ordering, and broad interoperability are commonplace in modern systems.[7] And those systems continue to advance, with machine learning now finding its way into a few laboratory data management and analysis workflows.[8][9]

We've come a long way since the 1960s, to a point where the question is no longer "can a computerized system help my food and beverage lab?" but rather "how do I choose and implement an informatics system to help my food and beverage lab?" As the previous chapter highlighted, a wide variety of standards and regulations further drive the narrative of "not if but when" for informatics systems acquisition. What follows is information to help you with this necessary acquisition, while considering the technology, features, security, cost, implementation, and vendor guarantees that come with such a system.

3.1 Evaluation and selection

What exactly is a laboratory information management system (LIMS) anyway? Do I need one? What options are available and how do I compare them? What about a request for information (RFI), request for proposal (RFP), or request for quotation (RFQ)? These are questions laboratory professionals typically ponder upon finding themselves charged with the mission of finding software for their food and beverage lab. For many the task can be a daunting proposition.

You may know the workflow-related needs of your laboratory, but perhaps you don't know much about data management solutions like LIMS, leaving you 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 very important factors. But these systems vary in numerous ways, and other important factors exist. Price should certainly be considered, 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 not only accomplish workflow tasks but also remain regulatory compliant?

These and other questions are addressed in this chapter.

3.1.1 Technology considerations

FDA Center for Food Safety & Applied Nutrition (CFSAN) 6496 (8756119526).jpg

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. The allergen, calorie, and nutrition testing lab, for example, may depend less on instrument integration than the stability, cycle, and challenge testing lab, with its microbiological workflows. As such, look at your laboratory's short- and long-term goals, budget, workflow, and regulatory requirements to gain a better understanding of what technology will be involved.

First, what are the laboratory's goals? Does the third-party laboratory owner envision a small investment, taking in a slow but steady flow of formulation requests, or do they envision expansive growth, expanding into multiple food and beverage 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. Second, 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, as well as requirements for retaining analytical results for regulators. The Laboratory Accreditation for Analyses of Foods (LAAF)-accredited testing lab will likely have many more instruments to cover all its testing needs, and its data management system will likely need to be able to interface to U.S. Food and Drug Administration (FDA) systems, or at a minimum report in their specific format. 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? (We talk about other cost considerations a bit later.)

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.[10] 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 (addressed later) 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? Remember that how you rank your cybersecurity preparedness and implement a cybersecurity plan will also guide your technology investment decisions.[11] Laboratory informatics options

Keeping the above in mind, what are the common software solutions used within a food and beverage laboratory? One of the more commonly discussed options is the LIMS, a laboratory informatics solution designed to assist laboratories with managing testing workflows, data, and other aspects of their operations.

The use of LIMS in food production facilities and labs is not a new concept.[12] However, little information can be found as to the percentage of today's food and beverage laboratories using a LIMS in their workflow. Several surveys from 2020, however, hint that LIMS are important to these types of labs. A survey of 135 professionals—nine percent of them from the food and beverage industry—from laboratory consultancy Astrix Technology found that more than 77 percent of respondents had at least one LIMS implemented in their organization.[13] A separate survey from Lab Manager about analytical instrument use among readers found that more than 16 percent of them were using instruments for food and beverage analysis.[14] Given the importance of integrating instrumentation and produced data in a food and beverage production and testing environment[15][16][17], a LIMS or other informatics solution appears to be increasingly critical to eliminating manual processes, improving sample management, increasing productivity, and improving regulatory conformance.[13] This, of course, lends to the food and beverage lab's focus on safety, quality, and compliance.

A LIMS can improve laboratory workflows and workloads while enhancing safety, quality, and compliance in a number of ways. A fragmented mix of paper-based and electronic information sources can be a detriment to the traceability of or rapid accessibility to ingredients, additives, quality control samples, standard operating procedures (SOPs), environmental monitoring data, chain of custody data, and other vital aspects of food and beverage production. A well-implemented LIMS can reduce the silos of information and data, while at the same time make that information and data more secure and readily accessible. Given the regulatory demands for providing rapid proof of traceable product movement and relevant quality control data, the LIMS acts as the central integrator and audit trail for that information.[15][18][19] 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, food and beverage producers can more rapidly act on insights gained from those real-time dashboards.[15] This also means that the food and beverage testing lab can react more rapidly to issues that compromise compliance with certification to the ISO 17025 standard or the FDA's Food Safety Modernization Act (FSMA) requirements.[16][20][21][22] Finally, many modern LIMS tailored to the food and beverage industry come pre-configured out of the box with analytical and quality control workflow support tools that can be further optimized to a lab's unique workflow.[23]

However, the LIMS is not the sole information management solution for food and beverage producers and laboratories. Software-based information management solutions are being marketed to food and beverage labs in other ways. Some vendors have taken to marketing the somewhat related laboratory execution system (LES), which tends to focus more on laboratory test method execution at the process level while integrating other R&D functionalities found in, for example, electronic laboratory notebooks (ELNs).[24][25] Other vendors have moved away from the "LIMS" and "LES" moniker completely, referring to their software as simply "food safety software." These offerings appear to focus on helping a producer do more than manage laboratory testing output by addressing other organizational needs such as developing regulatory-driven safety plans, generating schedules for environmental testing, improving communication and compliance, improving reaction time to non-conformances, improving audit readiness and reporting, ensuring greater compliance, and identifying trends across the entire enterprise.[26][27][28][29][30] In comparison, some LIMS may or may not address these issues; this functionality will be discussed further in the next subsection.

3.1.2 Features and functions

Given the above, it's clear LIMS adoption and use is important to the continued success of food and beverage labs. However, in most cases, a generic LIMS won't do; it's imperative the lab find a solution that meets all or most of its workflow requirements. This more often than not requires a configurable solution that enables trained users to quickly make the changes they need, if those changes make sense within the overall data structure of the LIMS. It also requires a solution that has been thoughtfully developed and continues to be carefully maintained to address the ever-shifting standard- and regulation-based requirements of the food and beverage laboratory. The following examines both the base features and specialty requirements of a food and beverage LIMS. Base features

What follows is a list of system functionality important to most any food and beverage laboratory, with a majority of that functionality found in many vendor software solutions.[15][16][18][19][23][24][31]

Test, sample, and result management

  • Sample log-in and management, with support for unique IDs
  • Sample batching
  • Barcode and RFID support
  • End-to-end sample and inventory tracking
  • Pre-defined and configurable industry-specific test and method management, including for bacteria (i.e., microbiology), heavy metals (i.e., chemistry), drug residues (i.e., pharmaceutical chemistry), and other substances
  • Pre-defined and configurable industry-specific workflows
  • Configurable screens and data fields
  • Specification management
  • Test, sampling, instrument, etc. scheduling and assignment
  • Test requesting
  • Data import and export
  • Robust query tools
  • Analytical tools, including data visualization, statistical analysis, and data mining tools
  • Document and image management
  • Version control
  • Project management
  • Method and protocol management
  • Investigation management
  • Facility and sampling site management
  • Storage management and monitoring

Quality, security, and compliance

  • Quality assurance / quality control mechanisms
  • Mechanisms for compliance with ISO 17025 and HACCP, including support for critical control point (CCP) specifications and limits
  • Result, method, protocol, batch, and material validation, review, and release
  • Data validation
  • Trend and control charting for statistical analysis and measurement of uncertainty
  • User qualification, performance, and training management
  • Audit trails and chain of custody support
  • Configurable and granular role-based security
  • Configurable system access and use (i.e., authentication requirements, account usage rules, account locking, etc.)
  • Electronic signature support
  • Data encryption and secure communication protocols
  • Archiving and retention of data and information
  • Configurable data backups
  • Status updates and alerts
  • Environmental monitoring support
  • Incident and non-conformance notification, tracking, and management

Operations management and reporting

  • Configurable dashboards for monitoring, by product, process, facility, etc.
  • Customizable rich-text reporting, with multiple supported output formats
  • Custom and industry-specific reporting, including certificates of analysis (CoAs)
  • Industry-compliant labeling
  • Email integration
  • Instrument interfacing and data management
  • Third-party software interfacing (e.g., LES, scientific data management system [SDMS], other database)
  • Data import, export, and archiving
  • Instrument calibration and maintenance tracking
  • Inventory and material management
  • Supplier/vendor/customer management
  • Integrated (or online) system help Specialty features

As noted previously, some software vendors are addressing food and beverage processor needs beyond the basic laboratory through their food safety software. A standard LIMS tailored for the food and beverage industry may already contribute to some of these wider organizational functions, as well as more advanced laboratory workflow requirements, but many may not, or may vary in what additional functionality they provide. In that regard, a food and beverage LIMS vendor may also include specialized functionality that helps the food and beverage producer and its laboratory[24][26][27][28][30][31][32][33][34][35][36][37]:

  • Manage stability studies: Just as with the pharmaceutical industry, stability studies play an important role in food and beverage safety. These studies require careful statistical analysis, predictive modelling, sensory analysis, quantitative descriptive testing, discrimination testing, microbiology testing, and more. This translates to a need for a wide variety of analytical and visualization tools, as well as LIMS support for a wide variety of test methods and limits. A robust LIMS should have these abilities, but not all do.
  • Manage recipes, as well as master and batch production records: This functionality is more in the domain of the LES or manufacturing execution system (MES). However, a few LIMS vendors may extend their LIMS to provide these features. Given that the HACCP rules, in particular, mandate the creation and management of batch production and in-process manufacturing material records, some food and beverage facilities testing batches and manufacturing materials may appreciate support in this regard.
  • Support molecular biology workflows: Molecular biology is an important tool in the research of improving foods, beverages, and their ingredients. However, not all LIMS are ideally equipped to handle related workflow aspects such as nucleic acid extraction, protein and cell isolation, and genotyping. A lab using such techniques may have to do extra due diligence in finding a food and beverage LIMS that also supports these workflow tasks.
  • Take advantage of ELN functionality: Given the level of R&D to be found in a food and beverage facility, the ELN is a familiar companion to other informatics systems. A few LIMS vendors may have a built-in ELN with their LIMS or offer an ELN that comes readily integrated with the LIMS. Some elements of ELN functionality may even be found in a few solutions. At a minimum—and nodded to in the base functionality above—the LIMS should support ELN functionality through its ability to effectively connect to a third-party ELN.
  • Develop regulatory-driven safety plans: The Hazard Analysis and Critical Control Points (HACCP) quality control method is recommended or required for food and testing labs (and is an influence on ISO 17025). Some LIMS vendors have recognized this and integrated support for building HACCP steps into laboratory workflows. In some cases this may be as sophisticated as allowing the user to diagram HACCP in their lab or facility as a visualization tool.
  • Generate schedules for environmental testing: While a LIMS can help assign and schedule a variety of laboratory tasks, broader organizational goals of testing the production environment on a scheduled, reportable basis may not be so straightforward, particularly without facility and sampling site management functionality that allows for highlighting specific test points in the facility. Even offsite or randomized testing may not be fully supported by a generic LIMS, requiring a LIMS flexible enough to compensate for the need for broader scheduled and randomized testing and retesting.
  • Improve reaction time to non-conformances: Many LIMS will have some basic form of non-conformance and incident management tools, but the robustness and extensibility of that functionality may be lacking. Can it send an SMS or email to the appropriate supplier in real-time when a pre-defined set of circumstances concerning that supplier's ingredients occurs? Can it re-prioritize or pause other related activities that are scheduled due to the identified non-conformance or incident? This is a useful area of functionality for the potential LIMS buyer to confirm with a vendor.
  • Improve audit readiness and reporting: A LIMS worth its weight will have a robust audit trail, to be sure. But can your LIMS help you audit your suppliers? Can it capture internal audit data on-demand and directly from the facility floor via mobile-friendly forms? Can HACCP- and audit-related data be flagged as such to make retrieval more efficient for audit purposes? These and other considerations may be important to a food and beverage facility, and not all food and beverage LIMS can provide.

3.1.3 Cybersecurity considerations

Measuring cybersecurity.png

From law firms[38] to automotive manufacturers[39], the need to address cybersecurity is increasingly apparent. In 2018, the Center for Strategic & International Studies estimated that cybercrime causes close to $600 billion in damages to the global economy every year[40], though due to underreporting of crimes, that number may be much higher. That number also likely doesn't take into account lost business, fines, litigation, and intangible losses[41] In the end, businesses of all sizes average about $200,000 in losses due to a cybersecurity incident[42], and nearly 60 percent of small and midsize businesses go bankrupt within six months because of it.[43]

Food and beverage laboratories are no exception, regardless of business size. Even tiny labs whose primary digital footprint is a WordPress website advertising their lab are at risk, as hackers could still spread malware, steal user data, add the website to a bot network, hack the site for the learning experience, or even hack it just for fun.[44][45][46] Even more importantly are those labs performing digital data management tasks that handle sensitive proprietary manufacturer data, requiring additional cybersecurity considerations.

A food and beverage manufacturer and its associated laboratories can integrate cybersecurity thinking into its laboratory informatics product selection in several ways. First, the organization should have a cybersecurity plan in place, or if not, it should be on the radar. This is a good resource to tap into in regards to deciding what cybersecurity considerations should be made for the software. Can the software help your organization meet your cybersecurity goals? What regulatory requirements for your lab are or are not covered by the software?[11] Another tool to consider—which may have been used in any prior cybersecurity planning efforts—is a cybersecurity framework. Many, but not all, cybersecurity frameworks include a catalog of security controls. Each control is "a safeguard or countermeasure prescribed for an information system or an organization designed to protect the confidentiality, integrity, and availability of its information and to meet a set of defined security requirements."[47] These controls give the implementing organization a concrete set of configurable goals to apply to their overall cybersecurity strategy. Other frameworks may be less oriented to security controls and more program-based or risk-based. Choosing the best frameworks will likely depend on multiple factors, including the organization's industry type, the amount of technical expertise within the organization, the budget, the organizational goals, the amount of buy-in from key organizational stakeholders, and those stakeholders' preferred approach.[11]

Finally, having an organizational cybersecurity plan that incorporates one or more cybersecurity frameworks gives the laboratory ample opportunity to apply stated goals and chosen security controls to the evaluation and selection process for its informatics software. In particular, a user requirements specification (URS) that incorporates cybersecurity considerations will certainly help a laboratory with meeting regulatory requirements while also protecting its data systems. A USR that is pre-built with cybersecurity controls in mind—such as LIMSpec, discussed later—makes the evaluation process even easier.

3.1.4 Regulatory compliance considerations

Without a doubt, it's vital that food and beverage laboratories operate within the bounds of a regulatory atmosphere, not only to better ensure the best consumer satisfaction outcomes but also to ensure the quality of test results, the safety of end users, and the promise of maintaining traceability across the utilized food chain. Maintaining regulatory compliance requires deliberate approaches to developing and enforcing processes and procedures, quality training, consistent communication, and knowledgeable personnel. It also requires a top-down appreciation and commitment to a culture of quality. From ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing and Codex Alimentarius CXS 234-1999 Recommended Methods of Analysis and Sampling to 21 CFR Part 120 (concerning hazard analysis and critical control point [HACCP] systems) and Safe Food for Canadians Regulations SOR/2018-108, laboratories have much to consider in regards to what standards and regulations impact them.

That said, consider approaching the question of regulatory compliance from the standpoint of adopting standards. Consider first that the risks and consequences of performing a task poorly drives regulation and, more preferably[48][49], 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"[49] 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.[48] In turn, the organizations that adopt well-designed standards 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 the standards and regulations that affect food and beverage laboratories. In turn, 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 a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed about all the regulations and standards that affect your lab. Turning to a URS such as LIMSpec—which was developed around laboratory regulations and standards—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.

3.1.5 System flexibility

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 food authenticity and adulteration testing, does your existing laboratory informatics system—or the ones you may be considering—have the flexibility to add other types of food and beverage 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 food 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 a LIMS 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.

3.1.6 Cost considerations

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 maintenance, support, and warranty (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.


  1. 1.0 1.1 1.2 Krieg, A.F. (1974). "Chapter 30: Clinical Laboratory Computerization". In Davidsohn, I.; Henry, J.B.. Clinical Diagnosis by Laboratory Methods. W.B. Saunders Company. pp. 1340–58. ISBN 0721629229. 
  2. Flynn, F.V. (1965). "Computer-assisted processing of bio-chemical test data". In Atkins, H.J.B.. Progress in Medical Computing. Blackwell Science Ltd. p. 46. ISBN 0632001801. 
  3. Williams, G.Z. (1964). "The Use of Data Processing and Automation in Clinical Pathology". Military Medicine 129 (6): 502–9. doi:10.1093/milmed/129.6.502. 
  4. Hicks, G.P.; Gieschen, M.M.; Slack, W.V. et al. (1966). "Routine Use of a Small Digital Computer in the Clinical Laboratory". JAMA 196 (11): 973–78. doi:10.1001/jama.1966.03100240107021. 
  5. Straumfjord, J.V.; Spraberry, M.N.; Biggs, H.G.; Noto, T.A. (1967). "Electronic Data Processing System for Clinical Laboratories: A System Used for All Laboratory Sections". American Journal of Clinical Pathology 47 (5_ts): 661–76. doi:10.1093/ajcp/47.5_ts.661. 
  6. Ball, M.J. (1970). "A Survey of Field Experience in Clinical Laboratory Computerization". Laboratory Medicine 1 (11): 25–27, 49–51. doi:10.1093/labmed/1.11.25. 
  7. Jones, R.G.; Johnson, O.A.; Batstone, G. (2014). "Informatics and the Clinical Laboratory". The Clinical Biochemist Reviews 35 (3): 177–92. PMC PMC4204239. PMID 25336763. 
  8. Burton, R. (19 July 2018). "NHS Laboratories Need Data Science". Towards Data Science. Retrieved 07 December 2022. 
  9. Cuff, J. (18 June 2018). "Augmenting Pathology Labs with Big Data and Machine Learning". The Next Platform. Retrieved 07 December 2022. 
  10. Izrailevsky, Y.; Bell, C. (2018). "Cloud Reliability". IEEE Cloud Computing 5 (3): 39–44. doi:10.1109/MCC.2018.032591615. 
  11. 11.0 11.1 11.2 Douglas, S.E. (July 2020). "Comprehensive Guide to Developing and Implementing a Cybersecurity Plan". LIMSwiki. 
  12. Çağındı, Özlem; Ötleş, Semih (1 December 2004). "Importance of laboratory information management systems (LIMS) software for food processing factories" (in en). Journal of Food Engineering 65 (4): 565–568. doi:10.1016/j.jfoodeng.2004.02.021. 
  13. 13.0 13.1 "Astrix 2020 LIMS Market Research Survey Report" (PDF). Astrix Technology, LLC. March 2021. Retrieved 07 December 2022. 
  14. Crawford-Brown, C. (25 March 2020). "Results from the Lab Manager Analytical Instrument Survey". Lab Manager. Retrieved 07 December 2022. 
  15. 15.0 15.1 15.2 15.3 Smith, K. (2 July 2019). "Integrated Informatics: Optimizing Food Quality and Safety by Building Regulatory Compliance into the Supply Chain". Food Safety Tech. Retrieved 07 December 2022. 
  16. 16.0 16.1 16.2 Apte, A. (20 October 2020). "Is Your Food Testing Lab Prepping for an ISO/IEC 17025 Audit?". Food Safety Tech. Retrieved 07 December 2022. 
  17. "Food & Beverage Process Automation and Instrumentation" (PDF). Siemens Industry, Inc. 2022. Retrieved 07 December 2022. 
  18. 18.0 18.1 McDermott, P. (31 July 2018). "How Digital Solutions Support Supply Chain Transparency and Traceability". Food Safety Tech. Retrieved 07 December 2022. 
  19. 19.0 19.1 Evans, K. (15 November 2019). "The Digital Transformation of Global Food Security". Food Safety Tech. Retrieved 07 December 2022. 
  20. Paszko, C. (19 August 2015). "Traceability: Leveraging Automation to Satisfy FSMA Requirements". Food Safety Tech. Retrieved 07 December 2022. 
  21. Paszko, C. (26 October 2015). "How LIMS Facilitates ISO 17025 Certification in Food Testing Labs". Food Safety Tech. Retrieved 07 December 2022. 
  22. Daniels, T. (22 March 2017). "Using LIMS to Get In Shape for FDA’s Visit". Food Safety Tech. Retrieved 07 December 2022. 
  23. 23.0 23.1 Ingalls, E. (6 August 2020). "How Advanced LIMS Brings Control, Consistency and Compliance to Food Safety". Food Safety Tech. Retrieved 07 December 2022. 
  24. 24.0 24.1 24.2 "iLES Food & Beverages Lab Execution". iVention BV. Retrieved 07 December 2022. 
  25. LabVantage Solutions (16 April 2020). "How LIMS can Improve your Food and Beverage Testing Lab". News Medical. Retrieved 07 December 2022. 
  26. 26.0 26.1 "What Is a Food Intelligence Platform? LIMS vs. Food Safety Software". 9 May 2019. Retrieved 07 December 2022. 
  27. 27.0 27.1 "Safety & Quality Management". FoodLogiQ. Retrieved 07 December 2022. 
  28. 28.0 28.1 "Food Safety Software". SafetyChain Software, Inc. Retrieved 07 December 2022. 
  29. "Best Food Safety Software For Quality Management Of Food". Folio3 Software, Inc. Retrieved 07 December 2022. 
  30. 30.0 30.1 "FoodDocs: AI-Powered Food Safety System with a HACCP builder". FoodDocs. Retrieved 07 December 2022. 
  31. 31.0 31.1 "STARLIMS Food and Beverage Industry LIMS Specification Document" (PDF). STARLIMS Corporation. November 2021. Retrieved 07 December 2022. 
  32. Douglas, S.E. (May 2022). "17. Production management". LIMSpec 2022 R2. Retrieved 07 December 2022. 
  33. Chen, Xinyu; Voigt, Tobias (1 August 2020). "Implementation of the Manufacturing Execution System in the food and beverage industry" (in en). Journal of Food Engineering 278: 109932. doi:10.1016/j.jfoodeng.2020.109932. 
  34. Kilcast, David; Subramaniam, Persis, eds. (2011). Food and beverage stability and shelf life. Woodhead Publishing series in food science, technology and nutrition. Oxford: WP, Woodhead Publ. ISBN 978-0-85709-254-0. OCLC 838321011. 
  35. Wolinsky, Howard; Husted, Kristofor (1 March 2015). "Science for food: Molecular biology contributes to the production and preparation of food" (in en). EMBO reports 16 (3): 272–275. doi:10.15252/embr.201540128. ISSN 1469-221X. PMC PMC4364866. PMID 25691389. 
  36. Jayashree, B; Reddy, Praveen T; Leeladevi, Y; Crouch, Jonathan H; Mahalakshmi, V; Buhariwalla, Hutokshi K; Eshwar, Ke; Mace, Emma et al. (1 December 2006). "Laboratory Information Management Software for genotyping workflows: applications in high throughput crop genotyping" (in en). BMC Bioinformatics 7 (1): 383. doi:10.1186/1471-2105-7-383. ISSN 1471-2105. PMC PMC1559653. PMID 16914063. 
  37. "Nucleic Acid Extraction For Food And Beverage Testing". Thermo Fisher Scientific. Retrieved 07 December 2022. 
  38. Sobowale, J. (1 March 2017). "Law firms must manage cybersecurity risks". ABA Journal. American Bar Association. Retrieved 07 December 2022. 
  39. Watney, C.; Draffin, C. (November 2017). "Addressing new challenges in automotive cybersecurity" (PDF). R Street Policy Study No. 118. R Street Institute. Retrieved 07 December 2022. 
  40. Lewis, J.A. (21 February 2018). "Economic Impact of Cybercrime". Center for Strategic & International Studies. Retrieved 07 December 2022. 
  41. "BLOG: Cost of Cyber Crime to Small Businesses". Virginia SBDC Blog. Virginia SBDC. 30 May 2017. Archived from the original on 05 July 2020. Retrieved 07 December 2022. 
  42. "Hiscox Cyber Readiness Report 2019" (PDF). Hiscox Ltd. April 2019. Retrieved 07 December 2022. 
  43. Galvin, J. (7 May 2018). "60 Percent of Small Businesses Fold Within 6 Months of a Cyber Attack. Here's How to Protect Yourself". Retrieved 07 December 2022. 
  44. Grima, M. (15 June 2022). "Top reasons why WordPress websites get hacked (and how you can stop it)". WP White Security. Retrieved 07 December 2022. 
  45. Moen, D. (19 April 2016). "What Hackers Do With Compromised WordPress Sites". Wordfence Blog. Defiant, Inc. Retrieved 07 December 2022. 
  46. Talaleve, A. (22 February 2022). "Website Hacking Statistics You Should Know in 2022". Patchstack. Retrieved 07 December 2022. 
  47. "security control". Computer Security Resource Center. National Institute of Standards and Technology. 2019. Retrieved 07 December 2022. 
  48. 48.0 48.1 Ciocoui, C.N.; Dobrea, R.C. (2010). "Chapter 1. The Role of Standardization in Improving the Effectiveness of Integrated Risk Management". In Nota, G.. Advances in Risk Management. IntechOpen. doi:10.5772/9893. ISBN 9789535159469. 
  49. 49.0 49.1 "Data Standardization: A Call to Action" (PDF). JPMorgan Chase & Co. May 2018. Retrieved 07 December 2022.