Template:LIMSpec/Artificial intelligence and smart systems - Revision history

Shawndouglas: Updated for food and bev update

2022-12-01T23:19:09Z

Updated for food and bev update

← Older revision		Revision as of 23:19, 1 December 2022
Line 59:		Line 59:
	[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://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, 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://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, PE-6(1)]<br />
Line 97:		Line 99:
	[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<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.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://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 />

Shawndouglas: Updated for 2022.

2022-05-05T20:43:16Z

Updated for 2022.

Show changes

Shawndouglas: Fixed broken URLs

2021-01-27T21:31:21Z

Fixed broken URLs

← Older revision		Revision as of 21:31, 27 January 2021
Line 59:		Line 59:
	[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 />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ 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, 9.5]<br />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18]		[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;" \|'''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.
	\|-		\|-
Line 86:		Line 86:
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />		[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<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://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ 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.
	\|-		\|-
	\|}		\|}
	\|}		\|}

Shawndouglas: Added NIST 800-53 to various items

2019-11-14T17:58:42Z

Added NIST 800-53 to various items

Shawndouglas: Created as needed.

2019-09-19T23:20:07Z

Created as needed.

New page

{|
| 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/Standards/E1578.htm 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="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm 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="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm 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="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm 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="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-5]
| 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="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="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] [https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]
| 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="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11] 
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17] 
[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11] 
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17] 
[https://www.law.cornell.edu/cfr/text/21/211.28 21 CFR Part 211.28] 
[https://www.law.cornell.edu/cfr/text/21/211.46 21 CFR Part 211.46] 
[https://www.law.cornell.edu/cfr/text/21/312.58 21 CFR Part 312.58 (b)] 
[https://www.law.cornell.edu/cfr/text/21/312.69 21 CFR Part 312.69] 
[https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11] 
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17] 
[https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310] 
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.3.1–2] 
[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] 
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.1.8] 
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.4.2] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-9] 
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.9.1.6] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.13] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.6] 
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.3] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.4] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.2] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 9.5] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18]
| 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] [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-10] [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="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11] 
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17] 
[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11] 
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17] 
[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (c)] 
[https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11] 
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17] 
[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252] 
[https://www.law.cornell.edu/cfr/text/42/493.1278 42 CFR Part 493.1278] 
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.3.1–2] 
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-22] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-11] 
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.2.6] 
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.3] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.4] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.4] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.2] 
[https://extranet.who.int/prequal/content/who-technical-report-series 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.
|-
|}
|}

← Older revision		Revision as of 17:58, 14 November 2019
Line 20:		Line 20:
	\| 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]		\| 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="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.
	\|-		\|-
Line 29:		Line 29:
	\| 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]		\| 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="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.
	\|-		\|-
Line 55:		Line 55:
	[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://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, 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 />