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30. Artificial Intelligence and Smart Systems

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 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 ISO 15189:2012 5.10.3 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 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 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 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 AAVLD Requirements for an AVMDL Sec. 5.3.1–2 ABFT Accreditation Manual Sec. E-22 ASTM E1578-18 E-16-11 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 OECD GLP Principles 10 USDA Sample Processing and Analysis Procedures for PDP 5.2 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.

31. Data Integrity

Regulation, Specification, or Guidance Requirement ASTM E1578-18 E-17-1 31.1 System functionality should support ALCOA principles. ASTM E1578-18 E-17-2 EPA 815-R-05-004 Chap. IV, Sec. 8 EPA ERLN Laboratory Requirements 4.8.6 EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7 31.2 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. ASTM E1578-18 E-17-3 21 CFR Part 58.190 EPA 815-R-05-004 Chap. IV, Sec. 8 EPA ERLN Laboratory Requirements 4.3.4.1 EPA ERLN Laboratory Requirements 4.8.6 EPA ERLN Laboratory Requirements 4.8.9 EPA ERLN Laboratory Requirements 4.9.9 OECD GLP Principles 10 USDA Administrative Procedures for the PDP 5.2.1 USDA Data and Instrumentation for PDP 8.1.3 31.3 The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review. 7 CFR Part 331.17 (c) 9 CFR Part 121.17 (c) 21 CFR Part 11.10 (c) 21 CFR Part 58.195 21 CFR Part 211.180 21 CFR Part 212.110 (c) 21 CFR Part 225.42 (b-8) 21 CFR Part 225.58 (c–d) 21 CFR Part 225.102 21 CFR Part 225.110 21 CFR Part 225.158 21 CFR Part 225.202 21 CFR Part 226.42 (a) 21 CFR Part 226.58 (f) 21 CFR Part 226.102 21 CFR Part 226.115 21 CFR Part 312.57 21 CFR Part 312.62 21 CFR Part 606.160 (d) 21 CFR Part 812.140 (d) 21 CFR Part 820.180 (b) 29 CFR Part 1910.1030 (h-2) 40 CFR Part 141.33 40 CFR Part 141.722 40 CFR Part 704 Subpart A 40 CFR Part 717.15 (d) 42 CFR Part 73.17 (c) 42 CFR Part 493.1105 42 CFR Part 493.1283 45 CFR Part 164.105 45 CFR Part 164.316 45 CFR Part 164.530 AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1 AAVLD Requirements for an AVMDL Sec. 4.10.1.2 AAVLD Requirements for an AVMDL Sec. 4.10.2.1 AAVLD Requirements for an AVMDL Sec. 5.4.3.2 ABFT Accreditation Manual Sec. E-33 AIHA-LAP Policies 2018 2A.7.5.1 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7 ASTM E1578-18 E-17-4 CJIS Security Policy 5.3.4 CJIS Security Policy 5.4.6–7 CJIS Security Policy 5.5.2.1 E.U. Annex 11-7.1 E.U. Commission Directive 2003/94/EC Article 9.1 E.U. Commission Directive 2003/94/EC Article 11.4 EPA 815-R-05-004 Chap. III, Sec. 15 EPA 815-R-05-004 Chap. IV, Sec. 8 EPA ERLN Laboratory Requirements 4.9.18 EPA ERLN Laboratory Requirements 4.11.17 EPA QA/G-5 2.1.9 ISO 15189:2012 4.3 ISO/IEC 17025:2017 8.4.2 OECD GLP Principles 10 USDA Administrative Procedures for the PDP 5.4 USDA Sampling Procedures for PDP 6.5 WHO Technical Report Series, #986, Annex 2, 15.8–9 31.4 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. ASTM E1578-18 E-17-6 CJIS Security Policy 5.4.4 31.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps. ASTM E1578-18 E-17-7 CJIS Security Policy 5.6.1 31.6 The system shall require each and every user to be assigned a unique user ID. ASTM E1578-18 E-17-8 21 CFR Part 11.10 (e) CJIS Security Policy 5.4.5 E.U. Annex 11-9 31.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts. CJIS Security Policy 5.4.2 31.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.