Difference between revisions of "Template:LIMSpec/Investigation and quality management"

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[https://www.law.cornell.edu/cfr/text/21/part-117 21 CFR Part 1.1152 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.81 21 CFR Part 58.81 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.81 21 CFR Part 58.81 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
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[https://www.law.cornell.edu/cfr/text/21/606.171 21 CFR Part 606.171]<br />
[https://www.law.cornell.edu/cfr/text/21/606.171 21 CFR Part 606.171]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1253 42 CFR Part 493.1253 (b-2)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1253 42 CFR Part 493.1253 (b-2)]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-16]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual F-2]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-16]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual J-3]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual F-2]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-1]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual J-3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-1]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.3]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.4]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.4]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.4]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.1.7]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.1.7]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.10.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.10.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.7.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.7]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 7.3]<br />
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 7.3]<br />
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.2.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.2.2]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.3]
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.6]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.3]
   | style="background-color:white;" |'''16.3''' The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
   | style="background-color:white;" |'''16.3''' The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-2]
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-2]<br />[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02005R2073-20200308 E.U. Commission Reg. No. 2073/2005 Article 9]
   | style="background-color:white;" |'''16.4''' The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.
   | style="background-color:white;" |'''16.4''' The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.
  |-  
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[https://www.law.cornell.edu/cfr/text/21/606.100 21 CFR Part 606.100 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/606.100 21 CFR Part 606.100 (c)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-3]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2.1]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.3]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.12]
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.12]<br />
   | style="background-color:white;" |'''16.5''' The system should trigger an alert or notification when an OOS/OOT status is found, prompting a documented investigation to identify the root cause.
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 11.12]
   | style="background-color:white;" |'''16.5''' The system should trigger an alert or notification when an OOS/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.
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   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/10/30.34 10 CFR Part 30.34 (g)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-112 21 CFR Part 112.147]<br />
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />
[https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />
Line 58: Line 73:
[https://www.law.cornell.edu/cfr/text/21/820.100 21 CFR Part 820.100]<br />
[https://www.law.cornell.edu/cfr/text/21/820.100 21 CFR Part 820.100]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-4]<br />
[https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.3]<br />
[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 Article 13]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.9 and 4.11]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-4]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.4.3]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.2]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.5]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.6.4]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-5]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-5]<br />
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.5.3]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (throughout)]<br />
[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.9]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13, 11.1]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]<br />
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 11.12]
   | style="background-color:white;" |'''16.6''' The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
   | style="background-color:white;" |'''16.6''' The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
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Line 71: Line 104:
[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1289 42 CFR Part 493.1289]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1289 42 CFR Part 493.1289]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-5]<br />
[https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.3]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.8 and 4.11]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-5]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.4.3]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.2]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.5]<br />
[https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.4]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.4]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.7]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.7]<br />
[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 Article 13]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-6(1)]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-4(1) and IR-5]<br />
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SI-2 and SI-4]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-6(1)]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-4(1) and IR-5]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-2 and SI-4]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.5.3]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
   | style="background-color:white;" |'''16.7''' The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.
   | style="background-color:white;" |'''16.7''' The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-6]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-6]
   | style="background-color:white;" |'''16.8''' The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.
   | style="background-color:white;" |'''16.8''' The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.
|-
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/9/2.35 9 CFR Part 2.35]
  | style="background-color:white;" |'''16.9''' The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag/tattoo number of the animal, the animal's description, etc.
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|}
|}
|}
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Latest revision as of 23:44, 14 December 2022

Regulation, Specification, or Guidance Requirement
21 CFR Part 312.62 (b)
21 CFR Part 812.140 (a-3)
16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.

21 CFR Part 312.57 (a)
21 CFR Part 312.62 (a)
21 CFR Part 606.165
21 CFR Part 812.140 (a-2) and (b-2)

16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.

21 CFR Part 1.1152 (c)
21 CFR Part 58.81 (a)
21 CFR Part 211.100
21 CFR Part 211.111
21 CFR Part 211.192
21 CFR Part 211.194
21 CFR Part 606.171
42 CFR Part 493.1253 (b-2)
A2LA C211 5.4
ABFT Accreditation Manual C-16
ABFT Accreditation Manual F-2
ABFT Accreditation Manual J-3
ASTM E1578-18 E-9-1
BRC GSFS, Issue 8, 5.6.2.3
BRC GSFS, Issue 8, 9.3.4
CLSI QMS22 2.2.2.2
EPA ERLN Laboratory Requirements 3.3
EPA QA/G-5 2.2.4
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1
ISO/IEC 17025:2017 7.2.1.7
ISO/IEC 17025:2017 7.2.2.1
ISO/IEC 17025:2017 7.10.2
ISO/IEC 17025:2017 8.7
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
OECD GLP Principles 7.3
PFP Human and Animal Food Testing Laboratories Best Practices Manual
TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)
USDA Administrative Procedures for the PDP 8.2.2
WADA International Standard for Laboratories (ISL) 5.3.6
WHO Technical Report Series, #986, Annex 2, 16.3

16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
42 CFR Part 493.1282
ASTM E1578-18 E-9-2
E.U. Commission Reg. No. 2073/2005 Article 9
16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.

21 CFR Part 606.100 (c)
42 CFR Part 493.1282
ASTM E1578-18 E-9-3
CLSI QMS22 2.1.2.1
CLSI QMS22 2.2.2.3
EPA QA/G-5 2.2.10
WHO Technical Report Series, #986, Annex 2, 17.12
WHO Technical Report Series, #996, Annex 5, 11.12

16.5 The system should trigger an alert or notification when an OOS/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.

10 CFR Part 30.34 (g)
21 CFR Part 112.147
21 CFR Part 225.58 (d)
21 CFR Part 225.158
21 CFR Part 606.100 (c)
21 CFR Part 820.100
42 CFR Part 493.1282
61 FR 38806, 9 CFR Part 417.3
A2LA C211 4.9 and 4.11
ASTM E1578-18 E-9-4
BRC GSFS, Issue 8, 3.4.3
BRC GSFS, Issue 8, 5.6.1.2
BRC GSFS, Issue 8, 9.3.5
CLSI QMS22 2.6.4
E.U. Commission Directive 2003/94/EC Article 13
FDA Hazard Analysis Critical Control Point Principle 5
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
NYSDOH ELAP Medical Marijuana Microbiology Guidance
NIST 800-53, Rev. 5, IR-5
PFP Human and Animal Food Testing Laboratories Best Practices Manual
SQF FSC 9, Food Manufacturing, Part B, 2.5.3
SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3
TNI EL-V1-2016-Rev.2.1 (throughout)
USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h
WADA International Standard for Laboratories (ISL) 5.3.9
WHO Technical Report Series, #961, Annex 13, 11.1
WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)
WHO Technical Report Series, #986, Annex 2, 5.0
WHO Technical Report Series, #996, Annex 5, 11.12

16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.

21 CFR Part 225.58 (d)
21 CFR Part 225.158
42 CFR Part 493.1282
42 CFR Part 493.1289
61 FR 38806, 9 CFR Part 417.3
A2LA C211 4.8 and 4.11
ASTM E1578-18 E-9-5
BRC GSFS, Issue 8, 3.4.3
BRC GSFS, Issue 8, 5.6.1.2
BRC GSFS, Issue 8, 9.3.5
CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition
CJIS Security Policy 5.3.4
CJIS Security Policy Appendix G.7
E.U. Commission Directive 2003/94/EC Article 13
FDA Hazard Analysis Critical Control Point Principle 5
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22
NYSDOH ELAP Medical Marijuana Microbiology Guidance
NIST 800-53, Rev. 5, AU-6(1)
NIST 800-53, Rev. 5, IR-4(1) and IR-5
NIST 800-53, Rev. 5, SI-2 and SI-4
SQF FSC 9, Food Manufacturing, Part B, 2.5.3
SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3
WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)
WHO Technical Report Series, #986, Annex 2, 5.0

16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.
ASTM E1578-18 E-9-6 16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.
9 CFR Part 2.35 16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag/tattoo number of the animal, the animal's description, etc.