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| | text = This is sublevel22 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p>
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| }}
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| ==Sandbox begins below==
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| {|
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| | STYLE="vertical-align:top;"|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
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| |-
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [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-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.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://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://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.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://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;" |'''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="padding:5px; width:500px;" |
| |
| [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-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-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.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://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://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.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://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;" |'''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;" |
| |
| [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://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;" |'''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/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="padding:5px; width:500px;" |
| |
| [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.astm.org/e1578-18.html ASTM E1578-18 D-1-5]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 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.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 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;" |'''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;" |
| |
| [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.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.4]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1]<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;" |'''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="padding:5px; width:500px;" |
| |
| [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/21/11.10 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.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://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://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://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;" |'''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/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="padding:5px; width:500px;" |[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;" |'''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="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.
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/9/2.32 9 CFR Part 2.32]<br />
| |
| [https://www.law.cornell.edu/cfr/text/10/20.2103 10 CFR Part 20.2103]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.120 29 CFR Part 1910.120]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (m)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-1)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (j)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/40/262.207 40 CFR Part 262.207]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.13.2.3]<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.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.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<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.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-3 and -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.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) and (h)]<br />
| |
| [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450 OSHA 1910.1450 (throughout)]<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 5.2)]<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 Sampling Procedures for PDP 6.1.2.8 and 6.1.3]<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]<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, 8.1]
| |
| | style="background-color:white;" |'''8.1''' The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/820.198 21 CFR Part 820.198]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1233 42 CFR Part 493.1233]<br />
| |
| [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<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 4.8)]<br />
| |
| [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.10]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (j)]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
| |
| | style="background-color:white;" |'''8.2''' The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br />
| |
| [https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
| |
| [https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<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/42/73.15 42 CFR Part 73.15]<br />
| |
| [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.2]<br />
| |
| [https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<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 5.9.3.3]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-1]<br />
| |
| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.1]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
| |
| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-2 and AT-3]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-3]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-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://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 5.2)]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2–3]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10]
| |
| | style="background-color:white;" |'''8.3''' The system shall allow training sessions and reviews to be scheduled for personnel.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
| |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<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 5.2.7]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-2]<br />
| |
| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
| |
| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]
| |
| | style="background-color:white;" |'''8.4''' The system should provide access to relevant training materials to personnel attending training sessions.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<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://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 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 C6.3]<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 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://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 5.2.6.2]<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 5.9.3.3 and 5.9.3.5]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-3]<br />
| |
| [https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition]<br />
| |
| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
| |
| [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 7.4]<br />
| |
| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-2–AT-4]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-3]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-2]<br />
| |
| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<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 5.2)]<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/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]<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]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (e)]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 9.4]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10]
| |
| | style="background-color:white;" |'''8.5''' The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-4]
| |
| | style="background-color:white;" |'''8.6''' The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-5]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-2 and AT-3]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-3]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-2]<br />
| |
| | style="background-color:white;" |'''8.7''' The system should be able to produce a training matrix of personnel.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<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/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/29/1910.1030 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 (e)]<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/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://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.2]<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.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 (various parts)]<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://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<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://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.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 1.1.2]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
| |
| | style="background-color:white;" |'''8.8''' The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
| |
| [https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17 ]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-7]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-1]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-9]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
| |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]
| |
| | style="background-color:white;" |'''9.1''' The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
| |
| [https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-2]<br />
| |
| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
| |
| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.5]<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]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-9]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-12.4]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
| |
| [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-2 and AU-3]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-5(1)]<br />
| |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
| |
| [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
| |
| [https://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://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]<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;" |'''9.2''' The system shall document in the audit trail any event—including administrative and privileged functions—that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<br />
| |
| [https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-3]<br />
| |
| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
| |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.2]<br />
| |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.3]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-12.4]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
| |
| [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-3 and AU-8]<br />
| |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.4]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
| |
| | style="background-color:white;" |'''9.3''' The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
| |
| [https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-4]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
| |
| [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
| |
| [https://ichgcp.net/ ICH GCP 4.9.0 and 4.9.3]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-3]<br />
| |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
| |
| | style="background-color:white;" |'''9.4''' The system's audit trail shall document the previous and current value of a modified field.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-5]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
| |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]
| |
| | style="background-color:white;" |'''9.5''' The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]
| |
| | style="background-color:white;" |'''9.6''' The system shall prevent a user from copying and pasting the electronic signature of another user.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (d)]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-9]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-6 and AU-12]<br />
| |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]
| |
| | style="background-color:white;" |'''9.7''' The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-1]
| |
| | style="background-color:white;" |'''10.1''' The system should provide a means for tracking usage of laboratory equipment and instruments.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-2]
| |
| | style="background-color:white;" |'''10.2''' The system shall provide a means for planning the use of and reserving equipment and instruments.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-3]
| |
| | style="background-color:white;" |'''10.3''' The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-4]
| |
| | style="background-color:white;" |'''10.4''' The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-5]
| |
| | style="background-color:white;" |'''10.5''' The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-6]
| |
| | style="background-color:white;" |'''10.6''' The system shall be able to group instruments together in specific ways, including by type and laboratory location.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.67 21 CFR Part 211.67–68]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.30 21 CFR Part 212.30 (b)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.30 21 CFR Part 225.30 (b-4)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606.60 21 CFR Part 606.60]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (g)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (b-3)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.5.2]<br />
| |
| [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.5]<br />
| |
| [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
| |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20]<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 C1.5]<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 5.6.1.1]<br />
| |
| [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2C.3.7–2C.3.10]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-7]<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://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.6.1]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.7]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2 and MA-2(2)]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.2]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6]<br />
| |
| [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.4]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.5]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
| |
| | style="background-color:white;" |'''10.7''' The system shall allow for the configuration of calibration and maintenance frequency and time frames for—as well as the manual and automatic scheduling of calibration or maintenance of—equipment, instruments, and systems. Available intervals should be include days, weeks, months, and years.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/225.30 21 CFR Part 225.30 (b-4)]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.9]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-8]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
| |
| | style="background-color:white;" |'''10.8''' The system shall provide clear alerts or notifications when an instrument nears its calibration due date.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.5.7]<br />
| |
| [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.6]<br />
| |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-21]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-9]<br />
| |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2.1]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.5]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.9]<br />
| |
| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<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 5.5.7)]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.10]
| |
| | style="background-color:white;" |'''10.9''' The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72 (b-2)]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-10]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
| |
| | style="background-color:white;" |'''10.10''' The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72 (b-1)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.6.2.1]<br />
| |
| [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.6]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.6.1–2]<br />
| |
| [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.5]<br />
| |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.2]<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 5.6.2.1 and 5.6.4.1)]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6.1]
| |
| | style="background-color:white;" |'''10.11''' The system shall be able to link a calibration activity to certified reference material or designated measurement processes.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-11]
| |
| | style="background-color:white;" |'''10.12''' The system shall support the use of predefined intervals when calculating instrument event dates.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.105 21 CFR Part 211.105 (b)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.5.4 and 5.5.5]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.4–5]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-12]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.7]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.13]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-8]<br />
| |
| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<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 5.5)]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.2]<br />
| |
| [https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j]<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 5.2.4]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13, 6.1]
| |
| | style="background-color:white;" |'''10.13''' The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information—such as manufacturer, model number, serial number, and calibration and maintenance history—within the system.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-13]
| |
| | style="background-color:white;" |'''10.14''' The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/10/20.2103 10 CFR Part 20.2103]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/58.63 21 CFR Part 58.63]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.67 21 CFR Part 211.67–68]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.182 21 CFR Part 211.182]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.30 21 CFR Part 212.30 (b)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (g)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1254 42 CFR Part 493.1254]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.13.2.1]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.5.2]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.10.4]<br />
| |
| [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
| |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20 and -23]<br />
| |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. F-1 and I-1]<br />
| |
| [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2C.3.7–2C.3.10]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-14]<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://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.1]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.4]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-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.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.2]<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 5.5)]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4]<br />
| |
| [https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c]<br />
| |
| [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.4]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.46]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
| |
| | style="background-color:white;" |'''10.15''' The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (a)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-1]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]<br />
| |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]
| |
| | style="background-color:white;" |'''11.1''' The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-2]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]
| |
| | style="background-color:white;" |'''11.2''' The system shall maintain the links between component parts of a batch and track the batch throughout the system.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.65 21 CFR Part 820.65]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-3]
| |
| | style="background-color:white;" |'''11.3''' The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-4]
| |
| | style="background-color:white;" |'''11.4''' The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-15]
| |
| | style="background-color:white;" |'''11.5''' The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-1]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.6–7]<br />
| |
| | style="background-color:white;" |'''12.1''' The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61 (a)]<br />[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166 (b)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-2]
| |
| | style="background-color:white;" |'''12.2''' The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-3]
| |
| | style="background-color:white;" |'''12.3''' The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-4]
| |
| | style="background-color:white;" |'''12.4''' The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-5]
| |
| | style="background-color:white;" |'''12.5''' The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-1]
| |
| | style="background-color:white;" |'''13.1''' The system shall be able to trigger an instrument event after a definable number of uses of that instrument.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-2]
| |
| | style="background-color:white;" |'''13.2''' The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-3]
| |
| | style="background-color:white;" |'''13.3''' The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-4]
| |
| | style="background-color:white;" |'''13.4''' The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-5]
| |
| | style="background-color:white;" |'''13.5''' The system should be able to accept the results uploaded from an interfaced instrument.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-6]
| |
| | style="background-color:white;" |'''13.6''' The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-7]
| |
| | style="background-color:white;" |'''13.7''' The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP/IP, and USB.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-8]
| |
| | style="background-color:white;" |'''13.8''' The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/58.83 21 CFR Part 58.83]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (g)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (h)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (c)]<br />
| |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-17]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-1]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4–5]<br />
| |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.4]
| |
| | style="background-color:white;" |'''14.1''' The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/7/331.3 7 CFR Part 331.3]<br />
| |
| [https://www.law.cornell.edu/cfr/text/9/121.3 9 CFR Part 121.3]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/312.58 21 CFR Part 312.58 (b)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/73.3 42 CFR Part 73.3–4 (c)]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-2]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.12]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 12.20]
| |
| | style="background-color:white;" |'''14.2''' The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and/or chemical stability.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-3]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4]
| |
| | style="background-color:white;" |'''14.3''' The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-4]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4]
| |
| | style="background-color:white;" |'''14.4''' The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-5]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4]
| |
| | style="background-color:white;" |'''14.5''' The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-1]<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.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]
| |
| | style="background-color:white;" |'''15.1''' The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (d)]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-2]<br />
| |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2]<br />
| |
| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]
| |
| | style="background-color:white;" |'''15.2''' The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.101 21 CFR Part 211.101]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e-6)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (f-6) and (f-10)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/40/262.206 40 CFR Part 262.206]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-3]<br />
| |
| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
| |
| [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1200 OSHA 1910.1200(b)(3) and (f)]<br />
| |
| [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450 OSHA 1910.1450(h)]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.10–12]
| |
| | style="background-color:white;" |'''15.3''' The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.50 21 CFR Part 820.50]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.6]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-4]<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 4.6.4)]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.1]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.8]
| |
| | style="background-color:white;" |'''15.4''' The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.196 21 CFR Part 211.196]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.90 21 CFR Part 212.90]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.110 21 CFR Part 225.110]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 Appendix A (I)]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.6]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-5]<br />
| |
| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<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 4.6.2)]<br />
| |
| [https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5]
| |
| | style="background-color:white;" |'''15.5''' The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.82 21 CFR Part 211.82 (b)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (a)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.142 21 CFR Part 211.142 (a)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-6]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 12.18]
| |
| | style="background-color:white;" |'''15.6''' The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-7]
| |
| | style="background-color:white;" |'''15.7''' The system should allow authorized personnel to retire faulty or poor quality materials from use.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-8]
| |
| | style="background-color:white;" |'''15.8''' The system shall clearly designate a standard or reagent as being disposed or consumed.
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62 (b)]<br />[https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (a-3)]
| |
| | style="background-color:white;" |'''16.1''' The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57 (a)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62 (a)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (a-2) and (b-2)]
| |
| | style="background-color:white;" |'''16.2''' The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/58.81 21 CFR Part 58.81 (a)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.111 21 CFR Part 211.111]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606.171 21 CFR Part 606.171]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1253 42 CFR Part 493.1253 (b-2)]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4]<br />
| |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-16]<br />
| |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual F-2]<br />
| |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual J-3]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-1]<br />
| |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.4]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.1.7]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.10.2]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.7.1]<br />
| |
| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
| |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 7.3]<br />
| |
| [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
| |
| [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.2.2]<br />
| |
| [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.6]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.3]
| |
| | style="background-color:white;" |'''16.3''' The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-2]
| |
| | style="background-color:white;" |'''16.4''' The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/606.100 21 CFR Part 606.100 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-3]<br />
| |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2.1]<br />
| |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.3]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.12]<br />
| |
| [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 11.12]
| |
| | style="background-color:white;" |'''16.5''' The system should trigger an alert or notification when an OOS/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/10/30.34 10 CFR Part 30.34 (g)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606.100 21 CFR Part 606.100 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.100 21 CFR Part 820.100]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.9 and 4.11]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-4]<br />
| |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.6.4]<br />
| |
| [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />
| |
| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
| |
| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
| |
| [https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-5]<br />
| |
| [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
| |
| [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (throughout)]<br />
| |
| [https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h]<br />
| |
| [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.9]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13, 11.1]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]<br />
| |
| [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 11.12]
| |
| | style="background-color:white;" |'''16.6''' The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1289 42 CFR Part 493.1289]<br />
| |
| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.8 and 4.11]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-5]<br />
| |
| [https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition]<br />
| |
| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.4]<br />
| |
| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.7]<br />
| |
| [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />
| |
| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
| |
| [https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-6(1)]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-4(1) and IR-5]<br />
| |
| [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-2 and SI-4]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
| |
| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
| |
| | style="background-color:white;" |'''16.7''' The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-6]
| |
| | style="background-color:white;" |'''16.8''' The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/9/2.35 9 CFR Part 2.35]
| |
| | style="background-color:white;" |'''16.9''' The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag/tattoo number of the animal, the animal's description, etc.
| |
| |-
| |
| |}
| |
| |}
| |
