Difference between revisions of "LII:LIMSpec/Introduction and methodology"

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This is where the intro goes.
==Introduction==
Over the years, a wide variety companies, consultants, and researchers have compiled public and private specification documents 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. More often than not, those requirements have been represented as a mix of "wishlist" requirements from potential and active clients, as well as regulation-mandated requirements. While this mix 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.
 
==Methodology==
At its core, this LIMSpec—which has seen several iterations over the years—is rooted in [[ASTM E1578|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 first revision taps into the following sources:
 
* [https://www.law.cornell.edu/cfr/text/7/part-331 7 CFR Part 331]
* [https://www.law.cornell.edu/cfr/text/9/part-121 9 CFR Part 121]
* [https://www.law.cornell.edu/cfr/text/21/part-7 21 CFR Part 7]
* [https://www.law.cornell.edu/cfr/text/21/part-11 21 CFR Part 11]
* [https://www.law.cornell.edu/cfr/text/21/part-58 21 CFR Part 58]
* [https://www.law.cornell.edu/cfr/text/21/part-211 21 CFR Part 211]
* [https://www.law.cornell.edu/cfr/text/21/part-212 21 CFR Part 212]
* [https://www.law.cornell.edu/cfr/text/21/part-225 21 CFR Part 225]
* [https://www.law.cornell.edu/cfr/text/21/part-226 21 CFR Part 226]
* [https://www.law.cornell.edu/cfr/text/21/part-312 21 CFR Part 312]
* [https://www.law.cornell.edu/cfr/text/21/part-606 21 CFR Part 606]
* [https://www.law.cornell.edu/cfr/text/21/part-810 21 CFR Part 810]
* [https://www.law.cornell.edu/cfr/text/21/part-812 21 CFR Part 812]
* [https://www.law.cornell.edu/cfr/text/21/part-820 21 CFR Part 820]
* [https://www.law.cornell.edu/cfr/text/29/1910.120 29 CFR Part 1910.120]
* [https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134]
* [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030]
* [https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096]
* [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200]
* [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450]
* [https://www.law.cornell.edu/cfr/text/40/part-3 40 CFR Part 3]
* [https://www.law.cornell.edu/cfr/text/40/part-60 40 CFR Part 60]
* [https://www.law.cornell.edu/cfr/text/40/part-62 40 CFR Part 62]
* [https://www.law.cornell.edu/cfr/text/40/part-63 40 CFR Part 63]
* [https://www.law.cornell.edu/cfr/text/40/part-141 40 CFR Part 141]
* [https://www.law.cornell.edu/cfr/text/40/part-370 40 CFR Part 370]
* [https://www.law.cornell.edu/cfr/text/40/part-372 40 CFR Part 372]
* [https://www.law.cornell.edu/cfr/text/40/part-704 40 CFR Part 704]
* [https://www.law.cornell.edu/cfr/text/40/part-717 40 CFR Part 717]
* [https://www.law.cornell.edu/cfr/text/40/part-720 40 CFR Part 720]
* [https://www.law.cornell.edu/cfr/text/42/part-73 42 CFR Part 73]
* [https://www.law.cornell.edu/cfr/text/42/part-493 42 CFR Part 493]
* [https://www.law.cornell.edu/cfr/text/45/part-160 45 CFR Part 160]
* [https://www.law.cornell.edu/cfr/text/45/part-162 45 CFR Part 162]
* [https://www.law.cornell.edu/cfr/text/45/part-164 45 CFR Part 164]
* [https://www.law.cornell.edu/cfr/text/45/part-170 45 CFR Part 170]
* [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories]
* [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL]
* [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual]
* [https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018]
* [http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf  ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories]
* [https://www.astm.org/Standards/E1188.htm ASTM E1188-11]
* [https://www.astm.org/Standards/E1459.htm ASTM E1459-13]
* [https://www.astm.org/Standards/E1492.htm ASTM E1492-11]
* [https://www.astm.org/Standards/E1578.htm ASTM E1578-18]
* [https://www.cdc.gov/phin/tools/phinms/index.html CDC PHIN Messaging System]
* [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy]
* [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11]
* [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC]
* [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004]
* [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements v1.6]
* [https://www.epa.gov/geospatial/epa-metadata-technical-specification EPA Metadata Technical Specification]
* [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5]
* [https://www.epa.gov/sites/production/files/2015-07/documents/sedd52_specification.pdf EPA SEDD Specification and Data Element Dictionary v5.2]
* [https://elexnet.fda.gov/elex/documents/eLEXNET_DX_Brochure_Aug_2011.pdf FDA eLEXNET Data Exchange Program]
* [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (HACCP)]
* [https://www.icar.org/Guidelines/15-Data-Exchange.pdf ICAR 15 Data Exchange]
* [https://www.iso.org/standard/56115.html ISO 15189:2012]
* [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017]
* [https://www.aphis.usda.gov/animal_health/nahln/downloads/MessagingQuickGuide.pdf NAHLN HL7 Messaging Quick User Guide]
* [https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/lab-info-services/nahln/ct_nahln_it NAHLN Information Technology System]
* [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles]
* [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the Pesticide Data Program (PDP)]
* [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP]
* [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP]
* [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP]
* [http://venomcoding.org/ VeNom Coding Group terminology]
* [https://vtsl.vetmed.vt.edu/ Veterinary Terminology Services Laboratory terminology]
* [https://vichsec.org/en/guidelines/general VICH GL53]
* [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2 ]

Revision as of 00:23, 20 September 2019

Introduction

Over the years, a wide variety companies, consultants, and researchers have compiled public and private specification documents 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. More often than not, those requirements have been represented as a mix of "wishlist" requirements from potential and active clients, as well as regulation-mandated requirements. While this mix 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.

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 first revision taps into the following sources:

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