Difference between revisions of "User:Shawndouglas/sandbox/sublevel20"

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Each requirement statement has at least one linked regulation, standard, or guidance item. In some cases, the standards covered are proprietary. In those cases, the standard was either purchased for review or heavily researched using supporting documentation, and the link goes to the acquisition page for the standard. In other cases, some sources have been intentionally omitted. For example, the AOAC International ''Official Methods of Analysis'' and ''Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals'' are both proprietary and more or less prohibitively expensive. In other cases such as the U.S. Food Emergency Response Network and Laboratory Response Network, they simply don't make their standardized procedures open to the public.
Each requirement statement has at least one linked regulation, standard, or guidance item. In some cases, the standards covered are proprietary. In those cases, the standard was either purchased for review or heavily researched using supporting documentation, and the link goes to the acquisition page for the standard. In other cases, some sources have been intentionally omitted. For example, the AOAC International ''Official Methods of Analysis'' and ''Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals'' are both proprietary and more or less prohibitively expensive. In other cases such as the U.S. Food Emergency Response Network and Laboratory Response Network, they simply don't make their standardized procedures open to the public.
CHANGES: FDA's eLEXNET was retired in September 2020 in favor of the Office of Regulatory Affairs (ORA) Partners Portal (ORAPP).
* https://www.fda.gov/media/136254/download
* https://orapartners.fda.gov/webcenter/portal/ORAPARTNERS
* https://orapartners.fda.gov/webcenter/portal/ORAPARTNERS/pages_dataexchangeoverview
Added 7 CFR Part 91.
Added 42 CFR Part 93.
Added A2LA C211, Specific Checklist, Combined ISO/IEC 17025 and Veterinary Laboratory Accreditation Program.
Added A2LA C223, Specific Checklist, Forensic Examination Accreditation Program-Testing.
Added CAP Laboratory Accreditation Manual.
Added DoD General Data Validation Guidelines.
Added New York Department of Health Clinical Laboratory Standards of Practice, General Systems Standards.
Added OSHA 1910.1020, OSHA 1910.1200, and OSHA 1910.1450.
Added ICH GCP.
Added NIST 800-53, Rev. 4 updated to Rev. 5.
Added PFP Human and Animal Food Testing Laboratories Best Practices Manual.
Added TNI EL-V1-2016-Rev.2.1.
Added WHO Technical Report Series, #961, Annex 13.
Added WHO Technical Report Series, #996, Annex 5.
Added ONC United States Core Data for Interoperability (USCDI) standard (also see https://www.cdc.gov/coronavirus/2019-ncov/downloads/lab/hhs-laboratory-reporting-guidance-508.pdf)

Revision as of 18:02, 26 April 2022

This is sublevel20 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

Introduction

Systems Requirement Analysis.jpg

Merriam-Webster defines a "specification" as "a detailed precise presentation of something or of a plan or proposal for something."[1] 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.[2]

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 provide guidelines for how to apply those requirements.[3] The standard describes the characteristics that make up quality software requirement development, including aspects such as[4]:

  • correctly describing system behavior;
  • 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.[5]

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 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.[6][7][8] While this reasonable mix of requirements has served informatics software developers well[9], sometimes a fresh approach is required.

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.

Methodology

At its core, this LIMSpec—which has seen several iterations over the years—is rooted in ASTM E1578-18 Standard Guide for Laboratory Informatics. With the latest version released in 2018, an updated Laboratory Informatics Functional Requirements checklist is included in the appendix, which "covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide." It goes on to state that the checklist "is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system," though it is certainly "not meant to be exhaustive."

This 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. However, this should definitely be considered a work in progress, with more to be added with additional public and private comment on missing sources.

That said, this second revision taps into the following sources:

Each requirement statement has at least one linked regulation, standard, or guidance item. In some cases, the standards covered are proprietary. In those cases, the standard was either purchased for review or heavily researched using supporting documentation, and the link goes to the acquisition page for the standard. In other cases, some sources have been intentionally omitted. For example, the AOAC International Official Methods of Analysis and Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals are both proprietary and more or less prohibitively expensive. In other cases such as the U.S. Food Emergency Response Network and Laboratory Response Network, they simply don't make their standardized procedures open to the public.

  1. ↑ "specification". Merriam-Webster. Merriam-Webster, Inc. https://www.merriam-webster.com/dictionary/specification. Retrieved 20 September 2019. 
  2. ↑ Bieg, D.P. (August 2014). "Introduction" (PDF). Requirements Management: A Core Competency for Project and Program Success. Project Management Institute. p. 3. https://www.pmi.org/-/media/pmi/documents/public/pdf/learning/thought-leadership/pulse/requirements-management.pdf. Retrieved 20 September 2019. 
  3. ↑ "ISO/IEC/IEEE 29148:2018". International Organization for Standardization. November 2018. https://www.iso.org/standard/72089.html. Retrieved 20 September 2019. 
  4. ↑ Seibert, P. (28 July 2011). "How do you write software requirements? What are software requirements? What is a software requirement?". HubTechInsider. https://hubtechinsider.wordpress.com/2011/07/28/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement/. Retrieved 20 September 2019. 
  5. ↑ Memon, A. (Spring 2010). "Software Requirements: Descriptions and specifications of a system" (PDF). University of Maryland. https://www.cs.umd.edu/~atif/Teaching/Spring2010/Slides/3.pdf. Retrieved 20 September 2019. 
  6. ↑ Aasem, M.; Ramzan, M.; Jaffar, A. (2010). "Analysis and optimization of software requirements prioritization techniques". Proceedings from the 2010 International Conference on Information and Emerging Technologies: 1–6. doi:10.1109/ICIET.2010.5625687. 
  7. ↑ Hirsch, J. (22 November 2013). "10 Steps To Successful Requirements Gathering". Phase2 Technology, LLC. https://www.phase2technology.com/blog/successful-requirements-gathering. Retrieved 20 September 2019. 
  8. ↑ Burris, E. (2007). "Requirements Specification". CS451R, University of Missouri–Kansas City. University of Missouri–Kansas City. Archived from the original on 24 July 2019. https://web.archive.org/web/20190724173601/http://sce2.umkc.edu/BIT/burrise/pl/requirements/. Retrieved 02 February 2020. 
  9. ↑ Hofmann, H.F.; Lehner, F. (2001). "Requirements engineering as a success factor in software projects". IEEE Software 18 (4): 58–66. doi:10.1109/MS.2001.936219. 
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