View source for LIMSpec for Cannabis Testing/Maintaining laboratory workflow and operations/Investigation and quality management

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  ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62 (b)]<br />▪ [https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (a-3)]
  | style="background-color:white; vertical-align: text-top;" |'''16.1''' The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57 (a)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62 (a)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (a-2) and (b-2)]
  | style="background-color:white; vertical-align: text-top;" |'''16.2''' The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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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/21/211.100 21 CFR Part 211.100]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.111 21 CFR Part 211.111]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<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.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4]<br />
▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-16]<br />
▪ [https://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 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/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 7.2.2.1]<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 8.7]<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.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; vertical-align: text-top;" |'''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.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [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; vertical-align: text-top;" |'''16.4''' The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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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/42/493.1282 42 CFR Part 493.1282]<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://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.12]<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; vertical-align: text-top;" |'''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.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [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/21/225.158 21 CFR Part 225.158]<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/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.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 4.9 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://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://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<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://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; vertical-align: text-top;" |'''16.6''' The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |
▪ [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/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.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 Appendix G.7]<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://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://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, AU-6(1)]<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://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; vertical-align: text-top;" |'''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.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-6]
  | style="background-color:white; vertical-align: text-top;" |'''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.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | 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.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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