Difference between revisions of "Template:LIMSpec/Document management"

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[https://www.law.cornell.edu/cfr/text/7/331 7 CFR Part 331 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/7/part-331 7 CFR Part 331 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/9/121 9 CFR Part 121 (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/21/7 21 CFR Part 7 (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/21/58 21 CFR Part 58 (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/21/211 21 CFR Part 211 (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/21/212 21 CFR Part 212 (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/21/225 21 CFR Part 225 (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/21/226 21 CFR Part 226 (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/21/312 21 CFR Part 312 (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/21/606 21 CFR Part 606 (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/21/810 21 CFR Part 810 (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/21/812 21 CFR Part 812 (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/21/820 21 CFR Part 820 (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/29/1910.134 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/29/1910.1030 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/29/1910.1200 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/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/42/73 42 CFR Part 73 (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/42/493.1200 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/42/493.1232 42 CFR Part 493.1232]<br />
Line 33: Line 36:
[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (j)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1291 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.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.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.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL (throughout)]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual (throughout)]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual (throughout)]<br />
[https://www.astm.org/Standards/E1188.htm ASTM E1188-11 3.5.2]<br />
[https://www.astm.org/e1188-11r17.html ASTM E1188-11 3.5.2]<br />
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.3.3.3 and 4.4.4]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.3.3.3 and 4.4.4]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-1]<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.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://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/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://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<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 (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://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 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 5.5.3]<br />
Line 51: Line 67:
[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 5.5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8]<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 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 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://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2 (throughout)]
[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;" |'''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.
   | style="background-color:white;" |'''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.
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   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331 7 CFR Part 331 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/7/part-331 7 CFR Part 331 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/9/121 9 CFR Part 121 (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/21/7 21 CFR Part 7 (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/21/58 21 CFR Part 58 (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/21/211 21 CFR Part 211 (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/21/212 21 CFR Part 212 (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/21/225 21 CFR Part 225 (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/21/226 21 CFR Part 226 (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/21/312 21 CFR Part 312 (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/21/606 21 CFR Part 606 (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/21/810 21 CFR Part 810 (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/21/812 21 CFR Part 812 (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/21/820 21 CFR Part 820 (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/29/1910.134 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/29/1910.1030 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/29/1910.1200 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/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/42/73 42 CFR Part 73 (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/42/493.1200 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/42/493.1232 42 CFR Part 493.1232]<br />
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[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (j)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1291 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/42/493.1773 42 CFR Part 493.1773 (c–d)]<br />
[https://www.law.cornell.edu/cfr/text/45/part-160.310 45 CFR Part 160.310]<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.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.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.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL (throughout)]<br />
[https://www.astm.org/Standards/E1188.htm ASTM E1188-11 3.5.2]<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.astm.org/Standards/E1492.htm ASTM E1492-11 4.3.3.3 and 4.4.4]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 Appendix H5.8]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-2]<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://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://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/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://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<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 (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://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/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/66912.html ISO/IEC 17025:2017 (throughout)]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8]<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 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 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.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2 (throughout)]
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) (throughout)]<br />
   | style="background-color:white;" |'''7.2''' The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.
[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;" |'''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.
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[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/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.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.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.3]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-3]<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://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/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.2]<br />
Line 119: Line 194:
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<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://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.5]
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.5]
   | style="background-color:white;" |'''7.3''' The system shall be able to clearly provide the most current version of a document and archive prior versions.
   | style="background-color:white;" |'''7.3''' The system shall be able to clearly provide the most current version of a document and archive prior versions.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-4]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-4]
   | style="background-color:white;" |'''7.4''' The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.  
   | style="background-color:white;" |'''7.4''' The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.  
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.21 21 CFR Part 211.21 (c)]<br />
[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/21/212.20 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/21/212.60 21 CFR Part 212.60 (c)]<br />
Line 132: Line 215:
[https://www.law.cornell.edu/cfr/text/21/820.250 21 CFR Part 820.250 (b)]<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.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (c)]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-5]<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://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 6.5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.1.3]<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/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.4]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.14]
[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;" |'''7.5''' The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.
   | style="background-color:white;" |'''7.5''' The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[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/21/212.20 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.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.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.4]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. G-12, -14, and -15]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. G-12, -14, and -15]<br />
[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 5.4.5.4]<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://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 7.2.2.1]<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/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.4]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 4.11]<br />
[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.13]
[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;" |'''7.6''' The system shall provide a means for recording validation information for modified existing or new in-house 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.
   | style="background-color:white;" |'''7.6''' The system shall provide a means for recording validation information for modified existing or new in-house 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.
  |-  
  |-  
Line 156: Line 283:
[https://www.law.cornell.edu/cfr/text/7/331.10 7 CFR Part 331.10]<br />
[https://www.law.cornell.edu/cfr/text/7/331.10 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/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/9/121.10 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/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/21/11.10 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/21/58.29 21 CFR Part 58.29]<br />
Line 170: Line 300:
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (h)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1200 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/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/42/73.10 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/42/73.15 42 CFR Part 73.15]<br />
Line 177: Line 309:
[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
[https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br />
[https://www.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.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. 5.2]<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 Sec. 5.4.2.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 (various parts)]<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 />
[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 4.13.2.12]<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 />
[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 5.2.1.1–3]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 (throughout)]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-5]<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://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-6]<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/Standards/E1578.htm ASTM E1578-18 E-1-6]<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://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<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 7.4]<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. 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://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://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 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 5.1.6]<br />
Line 200: Line 350:
[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 6.2.5]<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 6.2.6]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 1.1.2]<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.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;" |'''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 are able to perform assigned tasks.
   | style="background-color:white;" |'''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 are able to perform assigned tasks.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-7]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-7]
   | style="background-color:white;" |'''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.  
   | style="background-color:white;" |'''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.  
  |-  
  |-  
Line 210: Line 368:
   | style="background-color:white;" |'''7.9''' The system shall support the addition of accurate cross-references and page numbers to new documents.
   | style="background-color:white;" |'''7.9''' The system shall support the addition of accurate cross-references and page numbers to new documents.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.3.4]
   | style="padding:5px; width:500px;" |[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;" |'''7.10''' The system shall be capable of uniquely identifying documents created in and added to the system.
   | style="background-color:white;" |'''7.10''' The system shall be capable of uniquely identifying documents created in and added to the system.
|-
  | 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.
  |-  
  |-  
|}
|}
|}
|}

Latest revision as of 21:28, 4 January 2023

Regulation, Specification, or Guidance Requirement

7 CFR Part 331 (throughout)
9 CFR Part 121 (throughout)
10 CFR Part 20 (throughout)
21 CFR Part 7 (throughout)
21 CFR Part 117 (throughout)
21 CFR Part 58 (throughout)
21 CFR Part 211 (throughout)
21 CFR Part 212 (throughout)
21 CFR Part 225 (throughout)
21 CFR Part 226 (throughout)
21 CFR Part 312 (throughout)
21 CFR Part 606 (throughout)
21 CFR Part 810 (throughout)
21 CFR Part 812 (throughout)
21 CFR Part 820 (throughout)
29 CFR Part 1910.134 (throughout)
29 CFR Part 1910.1030 (throughout)
29 CFR Part 1910.1200 (throughout)
29 CFR Part 1910.1450 (throughout)
40 CFR Part 262.213–14
42 CFR Part 73 (throughout)
42 CFR Part 493.1200
42 CFR Part 493.1232
42 CFR Part 493.1239
42 CFR Part 493.1251
42 CFR Part 493.1291 (j)
45 CFR Part 164 (throughout)
61 FR 38806 (throughout)
A2LA C211 4.3
A2LA C223 4.13
AAFCO QA/QC Guidelines for Feed Laboratories (throughout)
AAVLD Requirements for an AVMDL (throughout)
ABFT Accreditation Manual (throughout)
ASTM E1188-11 3.5.2
ASTM E1492-11 4.3.3.3 and 4.4.4
ASTM E1578-18 D-1-1
BRC GSFS, Issue 8, 3.1.1
BRC GSFS, Issue 8, 3.2.1
BRC GSFS, Issue 8, 5.6.1.1
BRC GSFS, Issue 8, 5.6.2.2
BRC GSFS, Issue 8, 5.6.2.4
CAP Laboratory Accreditation Manual (throughout)
CJIS Security Policy (throughout)
EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)
EPA 815-R-05-004 (throughout)
EPA ERLN Laboratory Requirements (throughout)
EPA QA/G-5 (throughout)
E.U. Commission Directive 2003/94/EC (throughout)
FDA Hazard Analysis Critical Control Point (throughout)
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)
IFS Food 7, Part 2 (throughout)
IFS PACsecure 2, Part 2 (throughout)
ISO 15189:2012 4.3
ISO 15189:2012 5.5.3
ISO 15189:2012 5.9.3
ISO/IEC 17025:2017 5.3
ISO/IEC 17025:2017 5.5
ISO/IEC 17025:2017 8.3.2
ISO/TS 22002-1:2009 (throughout)
ISO/TS 22002-4:2013 (throughout)
ISO/TS 22002-6:2016 (throughout)
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
NYSDOH ELAP Medical Marijuana Microbiology Guidance
NIST 800-53, Rev. 5 (throughout)
OECD GLP Principles 8
OSHA 1910.1200(b)(3)
OSHA 1910.1450(e) and (h)
PFP Human and Animal Food Testing Laboratories Best Practices Manual
Safe Food for Canadians Regulations SOR/2018-108 (throughout)
SQF FSC 9, Food Manufacturing, Part B (throughout)
SQF FSC 9, Pet Food Manufacturing, Part B (throughout)
SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)
TNI EL-V1-2016-Rev.2.1 (throughout)
USDA Administrative Procedures for the PDP (throughout)
USDA Data and Instrumentation for PDP (throughout)
USDA Sample Processing and Analysis Procedures for PDP (throughout)
WHO Technical Report Series, #961, Annex 13 (throughout)
WHO Technical Report Series, #986, Annex 2 (throughout)
WHO Technical Report Series, #996, Annex 5 (throughout)

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.

7 CFR Part 331 (throughout)
9 CFR Part 121 (throughout)
21 CFR Part 1.1152 (c)
21 CFR Part 7 (throughout)
21 CFR Part 58 (throughout)
21 CFR Part 117 (throughout)
21 CFR Part 211 (throughout)
21 CFR Part 212 (throughout)
21 CFR Part 225 (throughout)
21 CFR Part 226 (throughout)
21 CFR Part 312 (throughout)
21 CFR Part 606 (throughout)
21 CFR Part 810 (throughout)
21 CFR Part 812 (throughout)
21 CFR Part 820 (throughout)
29 CFR Part 1910.134 (c)
29 CFR Part 1910.1030 (throughout)
29 CFR Part 1910.1200 (e)
29 CFR Part 1910.1450 (throughout)
40 CFR Part 262.214
42 CFR Part 73 (throughout)
42 CFR Part 93.300–5
42 CFR Part 493.1200
42 CFR Part 493.1232
42 CFR Part 493.1239
42 CFR Part 493.1251
42 CFR Part 493.1291 (j)
42 CFR Part 493.1773 (c–d)
45 CFR Part 160.310
45 CFR Part 164 (throughout)
61 FR 38806 (throughout)
A2LA C211 (throughout)
A2LA C223 (throughout)
AAFCO QA/QC Guidelines for Feed Laboratories (throughout)
AAVLD Requirements for an AVMDL (throughout)
ACMG Technical Standards for Clinical Genetics Laboratories (throughout)
AIHA-LAP Policies 2022 Appendix H5.8
ASTM E1188-11 3.5.2
ASTM E1492-11 4.3.3.3 and 4.4.4
ASTM E1578-18 D-1-2
BRC GSFS, Issue 8, 3.1.2
BRC GSFS, Issue 8, 3.3.1
BRC GSFS, Issue 8, 5.6.2.2
BRC GSFS, Issue 8, 5.6.2.4
CAP Laboratory Accreditation Manual (throughout)
CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)
CJIS Security Policy (throughout)
CLSI QMS22 (throughout)
EPA 815-R-05-004 (throughout)
EPA ERLN Laboratory Requirements (throughout)
EPA QA/G-5 (throughout)
E.U. Commission Directive 2003/94/EC (throughout)
FDA Hazard Analysis Critical Control Point (throughout)
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)
IFS Food 7, Part 2 (throughout)
IFS PACsecure 2, Part 2 (throughout)
ISO 15189:2012 (throughout)
ISO/IEC 17025:2017 (throughout)
ISO/TS 22002-1:2009 (throughout)
ISO/TS 22002-4:2013 (throughout)
ISO/TS 22002-6:2016 (throughout)
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
NYSDOH ELAP Medical Marijuana Microbiology Guidance
NIST 800-53, Rev. 5 (throughout)
OECD GLP Principles 8
OSHA 1910.1020 (throughout)
OSHA 1910.1200(b)(3)
OSHA 1910.1450(h)
PFP Human and Animal Food Testing Laboratories Best Practices Manual
Safe Food for Canadians Regulations SOR/2018-108 (throughout)
SQF FSC 9, Food Manufacturing, Part B (throughout)
SQF FSC 9, Pet Food Manufacturing, Part B (throughout)
SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)
TNI EL-V1-2016-Rev.2.1 (throughout)
USDA Administrative Procedures for the PDP (throughout)
USDA Data and Instrumentation for PDP (throughout)
USDA Hemp Production Program Laboratory Testing Guidelines (throughout)
USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3
USDA Sample Processing and Analysis Procedures for PDP (throughout)
WADA International Standard for Laboratories (ISL) (throughout)
WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)
WHO Technical Report Series, #961, Annex 13 (throughout)
WHO Technical Report Series, #986, Annex 2 (throughout)
WHO Technical Report Series, #996, Annex 5 (throughout)

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.

21 CFR Part 1.1154 (c)
21 CFR Part 820.40 (a)
42 CFR Part 493.1251 (e)
A2LA C211 4.3
AAVLD Requirements for an AVMDL Sec. 4.3
ASTM E1578-18 D-1-3
BRC GSFS, Issue 8, 3.2.1
EPA 815-R-05-004 Chap. III, Sec. 11
EPA ERLN Laboratory Requirements 4.2.4.2
EPA QA/G-5 2.1.9
ISO 15189:2012 4.3
ISO 15189:2012 5.5.3
ISO 15189:2012 5.9.3
ISO/IEC 17025:2017 7.5.2
ISO/IEC 17025:2017 8.3.2
USDA Administrative Procedures for the PDP 5.5
WHO Technical Report Series, #986, Annex 2, 15.5

7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.
ASTM E1578-18 D-1-4 7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.

21 CFR Part 1.1138
21 CFR Part 1.1151
21 CFR Part 1.1152 (e)
21 CFR Part 106.91 (c)
21 CFR Part 111.110
21 CFR Part 111.315
21 CFR Part 111.320
21 CFR Part 129.80 (g)
21 CFR Part 211.160
21 CFR Part 212.20 (c)
21 CFR Part 212.60 (c)
21 CFR Part 226.58 (e)
21 CFR Part 820.250 (b)
42 CFR Part 493.43 (c)
61 FR 38806, 9 CFR Part 310.25
61 FR 38806, 9 CFR Part 381.94
ASTM E1578-18 D-1-5
BRC GSFS, Issue 8, 5.6.1.1
BRC GSFS, Issue 8, 5.6.2.4
Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3
Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3
Codex Alimentarius CXS 234-1999 (throughout)
EPA 815-R-05-004 Chap. IV, Sec. 5
E.U. Commission Reg. No. 2073/2005 Article 5
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1
IFS Food 7, Part 2, 5.5.2
IFS Food 7, Part 2, 5.6.2
IFS PACsecure 2, Part 2, 5.5.2
IFS PACsecure 2, Part 2, 5.6.2
ISO/IEC 17025:2017 6.5
ISO/IEC 17025:2017 7.2.1.3
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
NYSDOH ELAP Medical Marijuana Microbiology Guidance
PFP Human and Animal Food Testing Laboratories Best Practices Manual
SQF FSC 9, Food Manufacturing, Part B, 2.4.4
SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4
TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)
USDA Administrative Procedures for the PDP 8.4
USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2
USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3
WADA International Standard for Laboratories (ISL) 4.2.1
WHO Technical Report Series, #986, Annex 2, 15.14

7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.

21 CFR Part 1.1138
21 CFR Part 1.1151
21 CFR Part 111.110
21 CFR Part 111.320
21 CFR Part 212.20 (c)
21 CFR Part 212.70 (b)
A2LA C211 5.4.5
A2LA C223 5.4
AAVLD Requirements for an AVMDL Sec. 5.4.2.4
ABFT Accreditation Manual Sec. G-12, -14, and -15
ACMG Technical Standards for Clinical Genetics Laboratories C10
ACMG Technical Standards for Clinical Genetics Laboratories F7.3
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4
Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3
Codex Alimentarius CXS 234-1999 (throughout)
EPA QA/G-5 2.2.4
E.U. Commission Reg. No. 2073/2005 Article 5
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1
ISO/IEC 17025:2017 6.2.6
ISO/IEC 17025:2017 7.2.2.1
ISO/IEC 17025:2017 7.2.2.4
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
NYSDOH ELAP Medical Marijuana Microbiology Guidance
PFP Human and Animal Food Testing Laboratories Best Practices Manual
TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)
USDA Administrative Procedures for the PDP 8.4
USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b
WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6
WHO Technical Report Series, #961, Annex 13, 10.1
WHO Technical Report Series, #986, Annex 2, 4.11
WHO Technical Report Series, #986, Annex 2, 15.13

7.6 The system shall provide a means for recording validation information for modified existing or new in-house 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.

7 CFR Part 331.10
7 CFR Part 331.15
9 CFR Part 2.32
9 CFR Part 121.10
9 CFR Part 121.15
10 CFR Part 30.34 (j-3)
21 CFR Part 1.1150
21 CFR Part 11.10 (i)
21 CFR Part 58.29
21 CFR Part 211.25
21 CFR Part 225.10
21 CFR Part 226.10
21 CFR Part 226.40
21 CFR Part 820.25
29 CFR Part 1910.134 (c)
29 CFR Part 1910.1030 (g-2)
29 CFR Part 1910.1030 (h-2)
29 CFR Part 1910.1200 (h)
29 CFR Part 1910.1450 (f)
40 CFR Part 262.207
40 CFR Part 262.210–12
42 CFR Part 73.10
42 CFR Part 73.15
42 CFR Part 493.43 (c)
42 CFR Part 493.1235
42 CFR Part 493.1251
45 CFR Part 164.308
45 CFR Part 164.530
61 FR 38806, 9 CFR Part 417.5
A2LA C211 5.2
A2LA C223 5.2
A2LA C223 5.7
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6
AAVLD Requirements for an AVMDL Sec. 5.2
AAVLD Requirements for an AVMDL Sec. 5.4.2.2
AAVLD Requirements for an AVMDL Appendix 1
ABFT Accreditation Manual Sec. B
ACMG Technical Standards for Clinical Genetics Laboratories B3–B5
ACMG Technical Standards for Clinical Genetics Laboratories C6.4
AIHA-LAP Policies 2022 (throughout)
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3
ASTM E1578-18 C-3-5
ASTM E1578-18 D-1-6
ASTM E1578-18 E-1-6
BRC GSFS, Issue 8, 5.6.2.3–4
BRC GSFS, Issue 8, 7.1.x
BRC GSFS, Issue 8, 9.3.4
CAP Laboratory Accreditation Manual
CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition
CLSI QMS22 (throughout)
E.U. Annex 11-2
E.U. Commission Directive 2003/94/EC Article 7.4
EPA 815-R-05-004 Chap. III, Sec. 10 and 17
EPA 815-R-05-004 Chap. IV, Sec. 1
EPA QA/G-5 2.1.8
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1
GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7
IFS Food 7, Part 2, 3.1
IFS Food 7, Part 2, 3.3
IFS PACsecure 2, Part 2, 3.1
IFS PACsecure 2, Part 2, 3.3
ISO 15189:2012 4.1.2.1
ISO 15189:2012 5.1.6
ISO 15189:2012 5.1.9
ISO/IEC 17025:2017 6.2.2
ISO/IEC 17025:2017 6.2.3
ISO/IEC 17025:2017 6.2.5
ISO/IEC 17025:2017 6.2.6
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
NYSDOH ELAP Medical Marijuana Microbiology Guidance
OECD GLP Principles 1.1.2
PFP Human and Animal Food Testing Laboratories Best Practices Manual
SQF FSC 9, Food Manufacturing, Part B, 2.9
SQF FSC 9, Pet Food Manufacturing, Part B, 2.9
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9
TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)
USDA Administrative Procedures for the PDP 6.1
WADA International Standard for Laboratories (ISL) 5.2.2

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 are able to perform assigned tasks.
ASTM E1578-18 D-1-7 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.
AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5
EPA ERLN Laboratory Requirements 4.10.6
7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.
AAVLD Requirements for an AVMDL Sec. 4.3.4
ISO/IEC 17025:2017 8.3.2
7.10 The system shall be capable of uniquely identifying documents created in and added to the system.
APHL 2019 LIS Project Management Guidebook
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.