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Introduction

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

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. The standard describes the characteristics that make up quality software requirement development, including aspects such as:

• 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.

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. While this reasonable mix of requirements has served informatics software developers well, 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 third revision taps into the following sources:

Table 1. Regulations, standards, guidance, and other documents guiding LIMSpec development. * indicates added, updated, or revised for 2022 update. Regulation, Specification, or Guidance Familiar Name and/or Responsible Entity 5 CFR Part 930.301 Office of Personnel Management > Civil Service Regulations > Programs for Specific Positions and Examinations (Miscellaneous) > Information Security Responsibilities for Employees who Manage or Use Federal Information Systems > Information systems security awareness training program 7 CFR Part 91* Agricultural Marketing Service (Standards, Inspections, Marketing Practices), Department of Agriculture > Commodity Laboratory Testing Programs > Services and General Information 7 CFR Part 331 Animal and Plant Health Inspection Service, Department of Agriculture > Possession, Use, and Transfer of Select Agents and Toxins 9 CFR Part 2* Animal and Plant Health Inspection Service, Department of Agriculture > Animal Welfare > Regulations 9 CFR Part 121 Animal and Plant Health Inspection Service, Department of Agriculture > Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors > Possession, Use, and Transfer of Select Agents and Toxins 10 CFR Part 20 Nuclear Regulatory Commission > Standards for Protection Against Radiation 10 CFR Part 30* Nuclear Regulatory Commission > Rules of General Applicability to Domestic Licensing of Byproduct Material 21 CFR Part 7 Food and Drug Administration, Department of Health and Human Services > General > Enforcement Policy 21 CFR Part 11 Food and Drug Administration, Department of Health and Human Services > General > Electronic Records; Electronic Signatures 21 CFR Part 58 Food and Drug Administration, Department of Health and Human Services > General > Good Laboratory Practice for Nonclinical Laboratory Studies 21 CFR Part 211 Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR Part 212 Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Positron Emission Tomography Drugs 21 CFR Part 225 Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Medicated Feeds 21 CFR Part 226 Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Type A Medicated Articles 21 CFR Part 312 Food and Drug Administration, Department of Health and Human Services > Drugs for Human Use > Investigational New Drug Application 21 CFR Part 606 Food and Drug Administration, Department of Health and Human Services > Biologics > Current Good Manufacturing Practice for Blood and Blood Components 21 CFR Part 810 Food and Drug Administration, Department of Health and Human Services > Medical Devices > Medical Device Recall Authority 21 CFR Part 812 Food and Drug Administration, Department of Health and Human Services > Medical Devices > Investigational Device Exemptions 21 CFR Part 820 Food and Drug Administration, Department of Health and Human Services > Medical Devices > Quality System Regulation 29 CFR Part 1910.120 Occupational Safety and Health Standards > Hazardous Materials > Hazardous waste operations and emergency response 29 CFR Part 1910.134 Occupational Safety and Health Standards > Personal Protective Equipment > Respiratory protection 29 CFR Part 1910.1030 Occupational Safety and Health Standards > Toxic and Hazardous Substances > Bloodborne pathogens 29 CFR Part 1910.1096 Occupational Safety and Health Standards > Toxic and Hazardous Substances > Ionizing radiation 29 CFR Part 1910.1200 Occupational Safety and Health Standards > Toxic and Hazardous Substances > Hazard communication 29 CFR Part 1910.1450 Occupational Safety and Health Standards > Toxic and Hazardous Substances > Occupational exposure to hazardous chemicals in laboratories 40 CFR Part 3 Environmental Protection Agency > General > Cross-media Electronic Reporting 40 CFR Part 60 Environmental Protection Agency > Air Programs > Standards of Performance for New Stationary Sources 40 CFR Part 62 Environmental Protection Agency > Air Programs > Approval and Promulgation of State Plans for Designated Facilities and Pollutants 40 CFR Part 63 Environmental Protection Agency > Air Programs > National Emission Standards for Hazardous Air Pollutants for Source Categories 40 CFR Part 141 Environmental Protection Agency > Water Programs > National Primary Drinking Water Regulations 40 CFR Part 262* Environmental Protection Agency > Solid Wastes > Standards Applicable to Generators of Hazardous Waste 40 CFR Part 370 Environmental Protection Agency > Superfund, Emergency Planning, and Community Right-to-know Programs > Hazardous Chemical Reporting: Community Right-to-know 40 CFR Part 372 Environmental Protection Agency > Superfund, Emergency Planning, and Community Right-to-know Programs > Toxic Chemical Release Reporting: Community Right-to-know 40 CFR Part 704 Environmental Protection Agency > Toxic Substances Control Act > Reporting and Recordkeeping Requirements 40 CFR Part 717 Environmental Protection Agency > Toxic Substances Control Act > Records and Reports of Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment 40 CFR Part 720 Environmental Protection Agency > Toxic Substances Control Act > Premanufacture Notification 42 CFR Part 73 Public Health Service, Department of Health and Human Services > Quarantine, Inspection, Licensing > Select Agents and Toxins 42 CFR Part 93* Public Health Service, Department of Health and Human Services > Health Assessments and Health Effects Studies of Hazardous Substances Releases and Facilities > Public Health Service Policies on Research Misconduct 42 CFR Part 493 Centers for Medicare & Medicaid Services, Department of Health and Human Services > Standards and Certification > Laboratory Requirements 45 CFR Part 160 Department of Health and Human Services > Administrative Data Standards and Related Requirements > General Administrative Requirements 45 CFR Part 162 Department of Health and Human Services > Administrative Data Standards and Related Requirements > Administrative Requirements 45 CFR Part 164 Department of Health and Human Services > Administrative Data Standards and Related Requirements > Security and Privacy 45 CFR Part 170 Department of Health and Human Services > Health Information Technology > Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology A2LA C211, Specific Checklist, Combined ISO/IEC 17025 and Veterinary Laboratory Accreditation Program* American Association for Laboratory Accreditation A2LA C223, Specific Checklist, Forensic Examination Accreditation Program-Testing* American Association for Laboratory Accreditation AAFCO QA/QC Guidelines for Feed Laboratories Association of American Feed Control Officials AAVLD Requirements for an AVMDL American Association of Veterinary Laboratory Diagnosticians ABFT Accreditation Manual American Board of Forensic Toxicology ACMG Technical Standards for Clinical Genetics Laboratories* American College of Medical Genetics and Genomics AIHA-LAP Policies 2022* American Industrial Hygiene Association Laboratory Accreditation Programs APHL 2019 LIS Project Management Guidebook* Association of Public Health Laboratories ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories American Society of Crime Laboratory Directors/Laboratory Accreditation Board; note that ASCLD/LAB merged with ANAB (ANSI National Accreditation Board) in 2016, and their requirements for Forensic Service Provider Accreditation are not made public. As such, this serves as a proxy for ANAB. ASTM E1188-11 ASTM E1188-11(2017) Standard Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator ASTM E1459-13 ASTM E1459-13(2018) Standard Guide for Physical Evidence Labeling and Related Documentation ASTM E1492-11 ASTM E1492-11(2017) Standard Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory ASTM E1578-18 ASTM E1578-18 Standard Guide for Laboratory Informatics CAP Laboratory Accreditation Manual* College of American Pathologists CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL)* U.S. Centers for Disease Control and Prevention CDC PHIN Messaging System U.S. Centers for Disease Control and Prevention CJIS Security Policy Federal Bureau of Investigation, Criminal Justice Information Services CLSI AUTO15* Clinical and Laboratory Standards Institute CLSI AUTO16* Clinical and Laboratory Standards Institute CLSI QMS22* Clinical and Laboratory Standards Institute DoD General Data Validation Guidelines* U.S. Department of Defense E.U. Annex 11 European Union, European Commission E.U. Commission Directive 2003/94/EC European Union, European Commission EMA Guidance on good manufacturing practice and good distribution practice* E.U. European Medicines Agency EPA 815-R-05-004 + supplements* U.S. Environmental Protection Agency EPA ERLN Laboratory Requirements v1.6 U.S. Environmental Protection Agency, Environmental Response Laboratory Network EPA Metadata Technical Specification U.S. Environmental Protection Agency EPA QA/G-5 U.S. Environmental Protection Agency Guidance for Quality Assurance Project Plans EPA SEDD Specification and Data Element Dictionary v5.2 U.S. Environmental Protection Agency Staged Electronic Data Deliverable FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program* U.S. Food and Drug Administration FDA Hazard Analysis Critical Control Point (HACCP) U.S. Food and Drug Administration ICAR 15 Data Exchange International Committee for Animal Recording ICH GCP* International Council for Harmonisation Good Clinical Practice ISO 15189:2012 ISO 15189:2012 Medical laboratories — Requirements for quality and competence ISO/IEC 17025:2017 ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories NAHLN HL7 Messaging Quick User Guide National Animal Health Laboratory Network NAHLN Information Technology System National Animal Health Laboratory Network NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards* New York State Department of Health Clinical Laboratory Evaluation Program NYSDOH ELAP Medical Marijuana Microbiology Guidance* New York State Department of Health Environmental Laboratory Approval Program NIST 800-53, Rev. 5* National Institute of Standards and Technology OECD GLP Principles Organisation for Economic Co-operation and Development Good Laboratory Practice ONC United States Core Data for Interoperability (USCDI)* Office of the National Coordinator for Health Information Technology OSHA 1910.1020* Occupational Safety and Health Administration 1910.1020 - Access to employee exposure and medical records OSHA 1910.1200* Occupational Safety and Health Administration 1910.1200 - Hazard Communication OSHA 1910.1450* Occupational Safety and Health Administration 1910.1450 - Occupational exposure to hazardous chemicals in laboratories PFP Human and Animal Food Testing Laboratories Best Practices Manual* Partnership for Food Protection TNI EL-V1-2016-Rev.2.1* The NELAC Institute Management and Technical Requirements for Laboratories Performing Environmental Analysis, Volume 1 USDA Administrative Procedures for the Pesticide Data Program (PDP) U.S. Department of Agriculture USDA Data and Instrumentation for Pesticide Data Program U.S. Department of Agriculture USDA Hemp Production Program Laboratory Testing Guidelines* U.S. Department of Agriculture USDA Laboratory Approval Service (LAS) Laboratory Approval Program (LAP) Policies and Procedures* U.S. Department of Agriculture USDA Sample Processing and Analysis Procedures for Pesticide Data Program U.S. Department of Agriculture USDA Sampling Procedures for Pesticide Data Program U.S. Department of Agriculture VeNom Coding Group terminology Veterinary Nomenclature VTSL terminology Veterinary Terminology Services Laboratory at Virginia-Maryland College of Veterinary Medicine VICH GL53 Veterinary International Conference on Harmonization GL53 Electronic Exchange of Documents: Electronic File Format WADA International Standard for Laboratories (ISL)* World Anti-Doping Agency WHO Technical Report Series, #961, Annex 13* World Health Organization TRS, #961, Annex 13 Guidelines for preparing a laboratory information file WHO Technical Report Series, #986, Annex 2 World Health Organization TRS, #986, Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles WHO Technical Report Series, #996, Annex 5* World Health Organization TRS, #996, Annex 5 Guidance on good data and record management practices

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.