Difference between revisions of "Template:LIMSpec for Cannabis Testing/Artificial intelligence and smart systems"
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Shawndouglas (talk | contribs) (Updated for 2023.) |
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! style="color:brown; background-color:#ffffee; width: | ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance | ||
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ||
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| style="background-color:white; vertical-align: text-top;" |'''21.7''' The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''21.7''' The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-8]<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 5.10.3]<br /> | |||
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)] | |||
| style="background-color:white; vertical-align: text-top;" |'''21.8''' The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''21.8''' The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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▪ [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310]<br /> | ||
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.3.4]<br /> | |||
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4.7.2]<br /> | |||
▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.3]<br /> | |||
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.3.1–2]<br /> | ▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.3.1–2]<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 5.3.4.1]<br /> | ||
▪ [https://www.astm.org/ | ▪ [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.8]<br /> | ||
▪ [https://www.astm.org/ | ▪ [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.4.2]<br /> | ||
▪ [https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-9]<br /> | ||
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.9.1.6]<br /> | ▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.9.1.6]<br /> | ||
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.2]<br /> | |||
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.13]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.13]<br /> | ||
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.6]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.6]<br /> | ||
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▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.3]<br /> | ▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.3]<br /> | ||
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.4]<br /> | ▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.4]<br /> | ||
▪ [https:// | ▪ [https://www.iso.org/standard/44001.html ISO/TS 22002-1:2009, 18.2]<br /> | ||
▪ [https:// | ▪ [https://www.iso.org/standard/60969.html ISO/TS 22002-4:2013, 4.15]<br /> | ||
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MP-2]<br /> | |||
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, PE-6(1)]<br /> | |||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br /> | ▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br /> | ||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.2]<br /> | ▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.2]<br /> | ||
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▪ [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/42/493.1278 42 CFR Part 493.1278]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1278 42 CFR Part 493.1278]<br /> | ||
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.3]<br /> | |||
▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.3]<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 C1.2]<br /> | |||
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.3.1–2]<br /> | ▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.3.1–2]<br /> | ||
▪ [ | ▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-22]<br /> | ||
▪ [https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-11]<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 2.2.3.5]<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.iso.org/standard/56115.html ISO 15189:2012 5.2.6]<br /> | ▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.2.6]<br /> | ||
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br /> | ▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br /> | ||
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▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.4]<br /> | ▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.4]<br /> | ||
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.4]<br /> | ▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.4]<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 10]<br /> | |||
▪ [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5]<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 5.8.4)]<br /> | |||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.2]<br /> | ▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.2]<br /> | ||
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11]<br /> | |||
▪ [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16] | ▪ [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16] | ||
| style="background-color:white; vertical-align: text-top;" |'''21.11''' The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''21.11''' The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> |
Revision as of 23:16, 22 June 2023
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