|
|
| (35 intermediate revisions by the same user not shown) |
| Line 7: |
Line 7: |
|
| |
|
| ==Sandbox begins below== | | ==Sandbox begins below== |
|
| |
| ==29. Artificial Intelligence and Smart Systems==
| |
| {|
| |
| | 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;" |'''29.1''' 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;" |'''29.2''' 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;" |'''29.3''' 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;" |'''29.4''' 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;" |'''29.5''' 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;" |'''29.6''' 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;" |'''29.7''' 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="background-color:white;" |'''29.8''' 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]<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.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://www.astm.org/Standards/E1492.htm 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/Standards/E1578.htm 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.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.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://extranet.who.int/prequal/content/who-technical-report-series 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]
| |
| | style="background-color:white;" |'''29.9''' 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="background-color:white;" |'''29.10''' 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]<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.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.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-11]<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 />
| |
| [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://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;" |'''29.11''' 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.
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| ==30. Data Integrity==
| |
| {|
| |
| | 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-17-1]
| |
| | style="background-color:white;" |'''30.1''' System functionality should support ALCOA principles.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-2]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]
| |
| | style="background-color:white;" |'''30.2''' The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-3]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]<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 Administrative Procedures for the PDP 5.2.1]<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;" |'''30.3''' The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
|
| |
| [https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/58.195 21 CFR Part 58.195]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.180 21 CFR Part 211.180]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 212.110 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.42 21 CFR Part 225.42 (b-8)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (c–d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.110 21 CFR Part 225.110]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.202 21 CFR Part 225.202]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.42 21 CFR Part 226.42 (a)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58 (f)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.115 21 CFR Part 226.115]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.180 21 CFR Part 820.180 (b)]<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/40/141.33 40 CFR Part 141.33]<br />
| |
| [https://www.law.cornell.edu/cfr/text/40/141.722 40 CFR Part 141.722]<br />
| |
| [https://www.law.cornell.edu/cfr/text/40/part-704/subpart-A 40 CFR Part 704 Subpart A]<br />
| |
| [https://www.law.cornell.edu/cfr/text/40/717.15 40 CFR Part 717.15 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1105 42 CFR Part 493.1105]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br />
| |
| [https://www.law.cornell.edu/cfr/text/45/164.105 45 CFR Part 164.105]<br />
| |
| [https://www.law.cornell.edu/cfr/text/45/164.316 45 CFR Part 164.316]<br />
| |
| [https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br />
| |
| [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.1.2]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.2.1]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.3.2]<br />
| |
| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-33]<br />
| |
| [https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.5.1]<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 4.14.1.2 and 4.15.1.2]<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 5.9.3.6 and 5.9.7]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-4]<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 5.4.6–7]<br />
| |
| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2.1]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-7.1]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 9.1]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 11.4]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 15]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.18]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.17]<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/66912.html ISO/IEC 17025:2017 8.4.2]<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 Administrative Procedures for the PDP 5.4]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.5]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.8–9]
| |
| | style="background-color:white;" |'''30.4''' The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.
| |
| |-
| |
| |}
| |
| |}
| |
