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[[File:Systems Requirement Analysis.jpg|700px|right]]Merriam-Webster defines a "specification" as "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=27 April 2022}}</ref> In other words, an existing or theoretical product, concept, or idea is presented in detail for a particular audience. In a broad sense, detailing the specifics about a project, concept, or idea to others is just common sense. This applies just as well to the world of software development, where a software requirements specification is essential for preventing the second most commonly cited reason for project failure: poor requirements management.<ref name="BiegRequire14">{{cite web |url=https://www.pmi.org/-/media/pmi/documents/public/pdf/learning/thought-leadership/pulse/requirements-management.pdf |format=PDF |title=Introduction |work=Requirements Management: A Core Competency for Project and Program Success |author=Bieg, D.P. |publisher=Project Management Institute |page=3 |date=August 2014 |accessdate=27 April 2022}}</ref>
<div class="nonumtoc">__TOC__</div>
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| text      = This is sublevel8 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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In fact, the ISO/IEC/IEEE 29148:2018 standard (a conglomeration of what was formerly IEEE 830 and other standards) is in place to help specify "the required processes implemented in the engineering activities that result in requirements for systems and software products" and provides guidelines for how to apply those requirements.<ref name="ISO29148">{{cite web |url=https://www.iso.org/standard/72089.html |title=ISO/IEC/IEEE 29148:2018 |publisher=International Organization for Standardization |date=November 2018 |accessdate=27 April 2022}}</ref> The standard describes the characteristics that make up quality software requirement development, including aspects such as<ref name="SeibertHowDoYou11">{{cite web |url=https://hubtechinsider.wordpress.com/2011/07/28/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement/ |title=How do you write software requirements? What are software requirements? What is a software requirement? |work=HubTechInsider |author=Seibert, P. |date=28 July 2011 |accessdate=27 April 2022}}</ref>:
==Sandbox begins below==
[[File:Battery Manufacturing Lab (50954228316).jpg|right|500px]]


* correctly describing system behavior;
'''Title''': ''LIMS Selection Guide for Manufacturing Quality Control''
* effectively removing ambiguity from the language used;
* completely covering the system behavior and features;
* accurately prioritizing and ranking the requirements; and
* unequivocally ensuring the requirements are testable, modifiable, and traceable.


A requirement typically comes in the form of a statement that begins with "the system/user/vendor shall/should ..." and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level) or specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered. An example of a functional software requirement could be "the user shall be able to query either all of the initial set of databases or select a subset from it." This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state "the system's query tool shall conform to the ABC 123-2014 standard." The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.<ref name="MemonSoftware10">{{cite web |url=https://www.cs.umd.edu/~atif/Teaching/Spring2010/Slides/3.pdf |format=PDF |title=Software Requirements: Descriptions and specifications of a system |author=Memon, A. |publisher=University of Maryland |date=Spring 2010 |accessdate=27 April 2022}}</ref>
'''Edition''': First Edition


Over the years, a wide variety of companies, consultants, and researchers have compiled public and private software requirements specifications for [[laboratory informatics]] systems. These compiled lists of requirements for how a given laboratory informatics solution should be developed, delivered, and maintained have changed as technology and user demand have evolved. Often times, these requirements documents turn into a mix of "wishlist" requirements from potential and active clients, as well as regulation-mandated requirements. The wishlist items aren't necessarily ignored by developers, but they do in fact have to be prioritized as "nice to have" or "essential to system operation," or something in between.<ref name="AasemAnalysis10">{{cite journal |title=Analysis and optimization of software requirements prioritization techniques |author=Aasem, M.; Ramzan, M.; Jaffar, A. |journal=Proceedings from the 2010 International Conference on Information and Emerging Technologies |pages=1–6 |year=2010 |doi=10.1109/ICIET.2010.5625687}}</ref><ref name="Hirsch10Steps13">{{cite web |url=https://www.phase2technology.com/blog/successful-requirements-gathering |title=10 Steps To Successful Requirements Gathering |author=Hirsch, J. |publisher=Phase2 Technology, LLC |date=22 November 2013 |accessdate=27 April 2022}}</ref><ref name="BurrissSoftware07">{{cite web |url=http://sce2.umkc.edu/BIT/burrise/pl/requirements/ |archiveurl=https://web.archive.org/web/20190724173601/http://sce2.umkc.edu/BIT/burrise/pl/requirements/ |title=Requirements Specification |work=CS451R, University of Missouri–Kansas City |author=Burris, E. |publisher=University of Missouri–Kansas City |date=2007 |archivedate=24 July 2019 |accessdate=27 April 2022}}</ref> While this reasonable mix of requirements has served informatics software developers well<ref name="HofmannRequire01">{{cite journal |title=Requirements engineering as a success factor in software projects |author=Hofmann, H.F.; Lehner, F. |journal=IEEE Software |volume=18 |issue=4 |pages=58–66 |year=2001 |doi=10.1109/MS.2001.936219}}</ref>, sometimes a fresh approach is required.
'''Author for citation''': Shawn E. Douglas


What follows is an attempt to look less at the wishlists of laboratories and more directly at what requirements current regulatory schemes, industry standards, and organizational guidelines place on the ever-evolving array of laboratory informatics systems being developed today. What does the United States' [[21 CFR Part 11]] have to say about how your [[laboratory information management system]] (LIMS), [[laboratory information system]] (LIS), [[electronic laboratory notebook]] (ELN), and other systems operate? What does the European Union's Annex 11 dictate in those same regards? The following five chapters list those requirements, supported by one or more regulations, standards, and guidelines. The final chapter discusses how to best put this requirements specification to use.
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]


==References==
'''Publication date''': To be determined
{{Reflist|colwidth=30em}}
 
 
To be written...
 
The table of contents for ''LIMS Selection Guide for Manufacturing Quality Control'' is as follows:
 
 
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Introduction to manufacturing laboratories|1. Introduction to manufacturing laboratories]]//-->
:[[User:Shawndouglas/sandbox/sublevel9|1. Introduction to manufacturing laboratories]]
::1.1 Manufacturing labs, then and now
::1.2 Laboratory roles and testing in the industry
:::1.2.1 R&D roles and testing
:::1.2.2 Pre-manufacturing and manufacturing roles and testing
:::1.2.3 Post-production regulation and security roles and testing
:::1.2.4 Tangential laboratory work
::1.3 Safety and quality in the manufacturing industry
 
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Standards and regulations affecting manufacturing labs|2. Standards and regulations affecting manufacturing labs]]//-->
:[[User:Shawndouglas/sandbox/sublevel10|2. Standards and regulations affecting manufacturing labs]]
::2.1 Globally recognized manufacturing standards
:::2.1.1 Food and beverage
:::2.1.2 Materials
:::2.1.3 Pharmaceutical and medical devices
:::2.1.4 Other industries
::2.2 Regulations and laws around the world
:::2.2.1 Food and beverage
:::2.2.2 Materials
:::2.2.3 Pharmaceutical and medical devices
:::2.3.4 Other industries
::2.3 Other influencing factors
:::2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)
:::2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)
 
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Choosing laboratory informatics software for your manufacturing lab|3. Choosing laboratory informatics software for your manufacturing lab]]//-->
:[[User:Shawndouglas/sandbox/sublevel11|3. Choosing laboratory informatics software for your manufacturing lab]]
::3.1 Evaluation and selection
:::3.1.1 Technology considerations
::::3.1.1.1 Laboratory informatics options
:::3.1.2 Features and functions
::::3.1.2.1 Base features
::::3.1.2.2 Specialty features
:::3.1.3 Cybersecurity considerations
:::3.1.4 Regulatory compliance considerations
:::3.1.5 System flexibility
:::3.1.6 Cost considerations
::3.2 Implementation
:::3.2.1 Internal and external integrations
::3.3 MSW, updates, and other contracted services
::3.4 How a user requirements specification fits into the entire process (LIMSpec)
 
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Resources for selecting and implementing informatics solutions|4. Resources for selecting and implementing informatics solutions]]//-->
:[[User:Shawndouglas/sandbox/sublevel12|4. Resources for selecting and implementing informatics solutions]]
::4.1 LIMS vendors
::4.2 Consultants
::4.3 Professional
:::4.3.1 Trade organizations
:::4.3.2 Conferences and trade shows
::4.4 LIMSpec
 
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Taking the next step|5. Taking the next step]]//-->
:[[User:Shawndouglas/sandbox/sublevel13|5. Taking the next step]]
::5.1 Conduct initial research into a specification document tailored to your lab's needs
::5.2 Issue some of the specification as part of a request for information (RFI)
::5.3 Respond to or open dialogue with vendors
:::5.3.1 The value of demonstrations
::5.4 Finalize the requirements specification and choose a vendor
 
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Closing remarks|6. Closing remarks]]//-->
:[[User:Shawndouglas/sandbox/sublevel14|6. Closing remarks]]
 
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Blank LIMSpec template for manufacturing labs|Appendix 1. Blank LIMSpec template for manufacturing labs]]//-->
:[[User:Shawndouglas/sandbox/sublevel15|Appendix 1. Blank LIMSpec template for manufacturing labs]]
::A1. Introduction and methodology
::A2. Primary laboratory workflow
::A3. Maintaining laboratory workflow and operations
::A4. Specialty laboratory functions
::A5. Technology and performance improvements
::A6. Security and integrity of systems and operations
::A7. Putting those requirements to practical use and caveats
::A8. LIMSpec in Microsoft Word format
 
<!---Place all category tags here-->

Revision as of 21:44, 21 March 2023

This is sublevel8 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead.

Sandbox begins below

Battery Manufacturing Lab (50954228316).jpg

Title: LIMS Selection Guide for Manufacturing Quality Control

Edition: First Edition

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: To be determined


To be written...

The table of contents for LIMS Selection Guide for Manufacturing Quality Control is as follows:


1. Introduction to manufacturing laboratories
1.1 Manufacturing labs, then and now
1.2 Laboratory roles and testing in the industry
1.2.1 R&D roles and testing
1.2.2 Pre-manufacturing and manufacturing roles and testing
1.2.3 Post-production regulation and security roles and testing
1.2.4 Tangential laboratory work
1.3 Safety and quality in the manufacturing industry
2. Standards and regulations affecting manufacturing labs
2.1 Globally recognized manufacturing standards
2.1.1 Food and beverage
2.1.2 Materials
2.1.3 Pharmaceutical and medical devices
2.1.4 Other industries
2.2 Regulations and laws around the world
2.2.1 Food and beverage
2.2.2 Materials
2.2.3 Pharmaceutical and medical devices
2.3.4 Other industries
2.3 Other influencing factors
2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)
2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)
3. Choosing laboratory informatics software for your manufacturing lab
3.1 Evaluation and selection
3.1.1 Technology considerations
3.1.1.1 Laboratory informatics options
3.1.2 Features and functions
3.1.2.1 Base features
3.1.2.2 Specialty features
3.1.3 Cybersecurity considerations
3.1.4 Regulatory compliance considerations
3.1.5 System flexibility
3.1.6 Cost considerations
3.2 Implementation
3.2.1 Internal and external integrations
3.3 MSW, updates, and other contracted services
3.4 How a user requirements specification fits into the entire process (LIMSpec)
4. Resources for selecting and implementing informatics solutions
4.1 LIMS vendors
4.2 Consultants
4.3 Professional
4.3.1 Trade organizations
4.3.2 Conferences and trade shows
4.4 LIMSpec
5. Taking the next step
5.1 Conduct initial research into a specification document tailored to your lab's needs
5.2 Issue some of the specification as part of a request for information (RFI)
5.3 Respond to or open dialogue with vendors
5.3.1 The value of demonstrations
5.4 Finalize the requirements specification and choose a vendor
6. Closing remarks
Appendix 1. Blank LIMSpec template for manufacturing labs
A1. Introduction and methodology
A2. Primary laboratory workflow
A3. Maintaining laboratory workflow and operations
A4. Specialty laboratory functions
A5. Technology and performance improvements
A6. Security and integrity of systems and operations
A7. Putting those requirements to practical use and caveats
A8. LIMSpec in Microsoft Word format


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