View source for LIMSpec for Cannabis Testing/Maintaining laboratory workflow and operations/Document 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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▪ [https://www.law.cornell.edu/cfr/text/7/part-331 7 CFR Part 331 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/part-121 9 CFR Part 121 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/10/part-20 10 CFR Part 20 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-7 21 CFR Part 7 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-117 21 CFR Part 117 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-58 21 CFR Part 58 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-211 21 CFR Part 211 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-212 21 CFR Part 212 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-225 21 CFR Part 225 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-226 21 CFR Part 226 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-312 21 CFR Part 312 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-606 21 CFR Part 606 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-810 21 CFR Part 810 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-812 21 CFR Part 812 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-820 21 CFR Part 820 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/40/262.214 40 CFR Part 262.213–14]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/part-73 42 CFR Part 73 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1200 42 CFR Part 493.1200]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1239 42 CFR Part 493.1239]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (j)]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/part-164 45 CFR Part 164 (throughout)]<br />
▪ [https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806 (throughout)]<br />
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.3]<br />
▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 4.13]<br />
▪ [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories (throughout)]<br />
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL (throughout)]<br />
▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual (throughout)]<br />
▪ [https://www.astm.org/e1188-11r17.html ASTM E1188-11 3.5.2]<br />
▪ [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.3.3.3 and 4.4.4]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-1]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.1.1]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.2.1]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.1]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.2]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.4]<br />
▪ [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual (throughout)]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy (throughout)]<br />
▪ [https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)]<br />
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 (throughout)]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements (throughout)]<br />
▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<br />
▪ [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC (throughout)]<br />
▪ [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (throughout)]<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 (throughout)]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2 (throughout)]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2 (throughout)]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 4.3]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.3]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.3]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 5.3]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 5.5]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<br />
▪ [https://www.iso.org/standard/44001.html ISO/TS 22002-1:2009 (throughout)]<br />
▪ [https://www.iso.org/standard/60969.html ISO/TS 22002-4:2013 (throughout)]<br />
▪ [https://www.iso.org/standard/66126.html ISO/TS 22002-6:2016 (throughout)]<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 (throughout)]<br />
▪ [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8]<br />
▪ [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1200 OSHA 1910.1200(b)(3)]<br />
▪ [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450 OSHA 1910.1450(e) and (h)]<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://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html Safe Food for Canadians Regulations SOR/2018-108 (throughout)]<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 (throughout)]<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 (throughout)]<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 (throughout)]<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/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP (throughout)]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13 (throughout)]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2 (throughout)]<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 (throughout)]
  | style="background-color:white; vertical-align: text-top;" |'''7.1''' The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/7/part-331 7 CFR Part 331 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/part-121 9 CFR Part 121 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-7 21 CFR Part 7 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-58 21 CFR Part 58 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-117 21 CFR Part 117 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-211 21 CFR Part 211 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-212 21 CFR Part 212 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-225 21 CFR Part 225 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-226 21 CFR Part 226 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-312 21 CFR Part 312 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-606 21 CFR Part 606 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-810 21 CFR Part 810 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-812 21 CFR Part 812 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-820 21 CFR Part 820 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (e)]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/40/262.214 40 CFR Part 262.214]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/part-73 42 CFR Part 73 (throughout)]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/93.300 42 CFR Part 93.300–5]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1200 42 CFR Part 493.1200]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1239 42 CFR Part 493.1239]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (j)]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1773 42 CFR Part 493.1773 (c–d)]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/160.310 45 CFR Part 160.310]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/part-164 45 CFR Part 164 (throughout)]<br />
▪ [https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806 (throughout)]<br />
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 (throughout)]<br />
▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 (throughout)]<br />
▪ [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories (throughout)]<br />
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL (throughout)]<br />
▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories (throughout)]<br />
▪ [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 Appendix H5.8]<br />
▪ [https://www.astm.org/e1188-11r17.html ASTM E1188-11 3.5.2]<br />
▪ [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.3.3.3 and 4.4.4]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-2]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.1.2]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.3.1]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.2]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.4]<br />
▪ [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual (throughout)]<br />
▪ [https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy (throughout)]<br />
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 (throughout)]<br />
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 (throughout)]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements (throughout)]<br />
▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<br />
▪ [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC (throughout)]<br />
▪ [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (throughout)]<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 (throughout)]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2 (throughout)]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2 (throughout)]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 (throughout)]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 (throughout)]<br />
▪ [https://www.iso.org/standard/44001.html ISO/TS 22002-1:2009 (throughout)]<br />
▪ [https://www.iso.org/standard/60969.html ISO/TS 22002-4:2013 (throughout)]<br />
▪ [https://www.iso.org/standard/66126.html ISO/TS 22002-6:2016 (throughout)]<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 (throughout)]<br />
▪ [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8]<br />
▪ [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1020 OSHA 1910.1020 (throughout)]<br />
▪ [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1200 OSHA 1910.1200(b)(3)]<br />
▪ [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450 OSHA 1910.1450(h)]<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://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html Safe Food for Canadians Regulations SOR/2018-108 (throughout)]<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 (throughout)]<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 (throughout)]<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 (throughout)]<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/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP (throughout)]<br />
▪ [https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines (throughout)]<br />
▪ [https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br />
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) (throughout)]<br />
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-protection-privacy-and-personal WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13 (throughout)]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2 (throughout)]<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 (throughout)]
  | style="background-color:white; vertical-align: text-top;" |'''7.2''' The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.<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-1 21 CFR Part 1.1154 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/820.40 21 CFR Part 820.40 (a)]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (e)]<br />
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.3]<br />
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.3]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-3]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.2.1]<br />
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 11]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.2]<br />
▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 4.3]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.3]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.3]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.5.2]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.5]
  | style="background-color:white; vertical-align: text-top;" |'''7.3''' The system shall be able to clearly provide the most current version of a document and archive prior versions.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
 |- 
  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-4]
  | style="background-color:white; vertical-align: text-top;" |'''7.4''' The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
 |- 
  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1138]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1151]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (e)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.91 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.110]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.315]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.320]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-129 21 CFR Part 129.80 (g)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/212.20 21 CFR Part 212.20 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58 (e)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/820.250 21 CFR Part 820.250 (b)]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (c)]<br />
▪ [https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 310.25]<br />
▪ [https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 381.94]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-5]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.1]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.4]<br />
▪ [https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3]<br />
▪ [https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3]<br />
▪ [https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf Codex Alimentarius CXS 234-1999 (throughout)]<br />
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 5]<br />
▪ [https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02005R2073-20200308 E.U. Commission Reg. No. 2073/2005 Article 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 19.1]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.5.2]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.6.2]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.5.2]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.6.2]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.5]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.1.3]<br />
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
▪ [https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<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, 2.4.4]<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, 2.4.4]<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, 2.4.4]<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 5.4)]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.4]<br />
▪ [https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2]<br />
▪ [https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3]<br />
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 4.2.1]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.14]
  | style="background-color:white; vertical-align: text-top;" |'''7.5''' The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
 |- 
  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1138]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1151]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.110]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.320]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/212.20 21 CFR Part 212.20 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/212.70 21 CFR Part 212.70 (b)]<br />
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4.5]<br />
▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.4]<br />
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.4]<br />
▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. G-12, -14, and -15]<br />
▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C10]<br />
▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories F7.3]<br />
▪ [https://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 5.4.5.4]<br />
▪ [https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3]<br />
▪ [https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf Codex Alimentarius CXS 234-1999 (throughout)]<br />
▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.4]<br />
▪ [https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02005R2073-20200308 E.U. Commission Reg. No. 2073/2005 Article 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 19.1]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.6]<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 7.2.2.4]<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://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 4.13.2.3)]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.4]<br />
▪ [https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b]<br />
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13, 10.1]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 4.11]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.13]
  | style="background-color:white; vertical-align: text-top;" |'''7.6''' The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
 |- 
  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |
▪ [https://www.law.cornell.edu/cfr/text/7/331.10 7 CFR Part 331.10]<br />
▪ [https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/2.32 9 CFR Part 2.32]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/121.10 9 CFR Part 121.10 ]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15 ]<br />
▪ [https://www.law.cornell.edu/cfr/text/10/30.34 10 CFR Part 30.34 (j-3)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1150]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (i)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/58.29 21 CFR Part 58.29]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/225.10 21 CFR Part 225.10]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/226.10 21 CFR Part 226.10]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/226.40 21 CFR Part 226.40]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/820.25 21 CFR Part 820.25]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g-2)]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-2)]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (h)]<br />
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
▪ [https://www.law.cornell.edu/cfr/text/40/262.207 40 CFR Part 262.207]<br />
▪ [https://www.law.cornell.edu/cfr/text/40/262.210 40 CFR Part 262.210–12]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/73.10 42 CFR Part 73.10]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1235 42 CFR Part 493.1235]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br />
▪ [https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.5]<br />
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.2]<br />
▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.2]<br />
▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.7]<br />
▪ [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6]<br />
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.2]<br />
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.2]<br />
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br />
▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories B3–B5]<br />
▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C6.4]<br />
▪ [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 (throughout)]<br />
▪ [https://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 4.13.2.12]<br />
▪ [https://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 5.2.1.1–3]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-5]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-6]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-6]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.3–4]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.1.x]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.4]<br />
▪ [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
▪ [https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition]<br />
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 (throughout)]<br />
▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<br />
▪ [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 7.4]<br />
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 10 and 17]<br />
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 1]<br />
▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1]<br />
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 3.1]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 3.3]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 3.1]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 3.3]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 4.1.2.1]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.6]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.2]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.3]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.5]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.6]<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://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 1.1.2]<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, 2.9]<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, 2.9]<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, 2.9]<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 4.13.3)]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.2]
  | style="background-color:white; vertical-align: text-top;" |'''7.7''' The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel—per state and local regulations—are able to perform assigned tasks.<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 D-1-7]
  | style="background-color:white; vertical-align: text-top;" |'''7.8''' The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<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.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5]<br />▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.6]
  | style="background-color:white; vertical-align: text-top;" |'''7.9''' The system shall support the addition of accurate cross-references and page numbers to new documents.<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.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.3.4]<br />▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]
  | style="background-color:white; vertical-align: text-top;" |'''7.10''' The system shall be capable of uniquely identifying documents created in and added to the system.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding:5px; width:500px;" |▪ [https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
  | style="background-color:white;" |'''7.11''' The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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