Difference between revisions of "Template:LIMSpec/Artificial intelligence and smart systems"

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   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-1]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-1]
   | style="background-color:white;" |'''30.1''' The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.
   | style="background-color:white;" |'''30.1''' The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-2]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-2]
   | style="background-color:white;" |'''30.2''' The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.
   | style="background-color:white;" |'''30.2''' The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-3]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-3]
   | style="background-color:white;" |'''30.3''' The system should support voice data capture and retrieval as smart laboratory assistance functions.
   | style="background-color:white;" |'''30.3''' The system should support voice data capture and retrieval as smart laboratory assistance functions.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-4]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-4]
   | style="background-color:white;" |'''30.4''' The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.
   | style="background-color:white;" |'''30.4''' The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm 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="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-5]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-6(2)]
   | style="background-color:white;" |'''30.5''' The system should support predictive maintenance routines for laboratory instruments and equipment.
   | style="background-color:white;" |'''30.5''' The system should support predictive maintenance routines for laboratory instruments and equipment.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-6]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-6]
   | style="background-color:white;" |'''30.6''' The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.
   | style="background-color:white;" |'''30.6''' The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-7]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-7]
   | style="background-color:white;" |'''30.7''' 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.
   | style="background-color:white;" |'''30.7''' 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.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-8]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SI-4(5) and SI-4(7)]
   | style="padding:5px; width:500px;" |[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;" |'''30.8''' 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.
   | style="background-color:white;" |'''30.8''' 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.
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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 />
[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1]<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/Standards/E1492.htm ASTM E1492-11 4.1.8]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.8]<br />
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.4.2]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.4.2]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-9]<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://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://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, MP-2]<br />
[https://www.iso.org/standard/44001.html ISO/TS 22002-1:2009, 18.2]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, PE-6(1)]<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 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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   | style="background-color:white;" |'''30.9''' 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.
   | style="background-color:white;" |'''30.9''' 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.
  |-   
  |-   
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-10]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]
   | style="padding:5px; width:500px;" |[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;" |'''30.10''' 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.
   | style="background-color:white;" |'''30.10''' 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.
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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 />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-22]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-22]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-11]<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 5.2.6]<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 />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<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;" |'''30.11''' 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.
   | style="background-color:white;" |'''30.11''' 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.

Latest revision as of 23:19, 1 December 2022

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-16-1 30.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.
ASTM E1578-18 E-16-2 30.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.
ASTM E1578-18 E-16-3 30.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.
ASTM E1578-18 E-16-4 30.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.
ASTM E1578-18 E-16-5
NIST 800-53, Rev. 5, MA-6(2)
30.5 The system should support predictive maintenance routines for laboratory instruments and equipment.
ASTM E1578-18 E-16-6 30.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.
ASTM E1578-18 E-16-7 30.7 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.
ASTM E1578-18 E-16-8
CLSI QMS22 2.1.2.1
ISO 15189:2012 5.10.3
NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)
30.8 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.

7 CFR Part 331.11
7 CFR Part 331.17
9 CFR Part 121.11
9 CFR Part 121.17
21 CFR Part 211.28
21 CFR Part 211.46
21 CFR Part 312.58 (b)
21 CFR Part 312.69
42 CFR Part 73.11
42 CFR Part 73.17
45 CFR Part 164.310
A2LA C211 5.3.4
A2LA C211 5.4.7.2
A2LA C223 5.3
AAVLD Requirements for an AVMDL Sec. 5.3.1–2
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1
ASTM E1492-11 4.1.8
ASTM E1492-11 4.4.2
ASTM E1578-18 E-16-9
CJIS Security Policy 5.9.1.6
CLSI QMS22 2.4.2
EPA ERLN Laboratory Requirements 4.1.13
EPA ERLN Laboratory Requirements 4.9.6
ISO 15189:2012 5.10.3
ISO/IEC 17025:2017 6.3.3
ISO/IEC 17025:2017 6.3.4
ISO/TS 22002-1:2009, 18.2
ISO/TS 22002-4:2013, 4.15
NIST 800-53, Rev. 5, MP-2
NIST 800-53, Rev. 5, PE-6(1)
USDA Administrative Procedures for the PDP 5.2.1
USDA Sample Processing and Analysis Procedures for PDP 5.2
WHO Technical Report Series, #986, Annex 2, 9.5
WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18

30.9 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.
42 CFR Part 493.1252
ASTM E1578-18 E-16-10
ISO 15189:2012 5.10.3
30.10 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.

7 CFR Part 331.11
7 CFR Part 331.17
9 CFR Part 121.11
9 CFR Part 121.17
21 CFR Part 820.70 (c)
42 CFR Part 73.11
42 CFR Part 73.17
42 CFR Part 493.1252
42 CFR Part 493.1278
A2LA C211 5.3
A2LA C223 5.3
ACMG Technical Standards for Clinical Genetics Laboratories C1.2
AAVLD Requirements for an AVMDL Sec. 5.3.1–2
ABFT Accreditation Manual Sec. E-22
ASTM E1578-18 E-16-11
CAP Laboratory Accreditation Manual
CLSI QMS22 2.2.3.5
EMA Guidance on Good Manufacturing Practice and Good Distribution Practice
ISO 15189:2012 5.2.6
ISO 15189:2012 5.10.3
ISO/IEC 17025:2017 6.3.3
ISO/IEC 17025:2017 6.3.4
ISO/IEC 17025:2017 7.4.4
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
OECD GLP Principles 10
PFP Human and Animal Food Testing Laboratories Best Practices Manual
SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5
SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5
TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)
USDA Sample Processing and Analysis Procedures for PDP 5.2
WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11
WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16

30.11 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.