View source for LIMSpec for Cannabis Testing/Technology and performance improvements/Artificial intelligence and smart systems

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  ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-1]
  | style="background-color:white; vertical-align: text-top;" |'''21.1''' The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-2]
  | style="background-color:white; vertical-align: text-top;" |'''21.2''' The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-3]
  | style="background-color:white; vertical-align: text-top;" |'''21.3''' The system should support voice data capture and retrieval as smart laboratory assistance functions.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-4]
  | style="background-color:white; vertical-align: text-top;" |'''21.4''' The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-5]<br />▪ [https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, MA-6(2)]
  | style="background-color:white; vertical-align: text-top;" |'''21.5''' The system should support predictive maintenance routines for laboratory instruments and equipment.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-6]
  | style="background-color:white; vertical-align: text-top;" |'''21.6''' The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-7]
  | 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 />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [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 />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.28 21 CFR Part 211.28]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.46 21 CFR Part 211.46]<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/21/312.69 21 CFR Part 312.69]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<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.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://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/e1492-11r17.html ASTM E1492-11 4.1.8]<br />
▪ [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.4.2]<br />
▪ [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://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 4.9.6]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<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/44001.html ISO/TS 22002-1:2009, 18.2]<br />
▪ [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 Sample Processing and Analysis Procedures for PDP 5.2]<br />
▪ [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 9.5]<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 12.18]
  | style="background-color:white; vertical-align: text-top;" |'''21.9''' The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252]<br />▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-10]<br />▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]
  | style="background-color:white; vertical-align: text-top;" |'''21.10''' The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |
▪ [https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1278 42 CFR Part 493.1278]<br />
▪ [https://www.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.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-22]<br />
▪ [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 5.10.3]<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 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.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]
  | 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 />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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