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| Regulation, Specification, or Guidance
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Requirement
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| ASTM E1578-18 E-16-1
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30.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.
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| ASTM E1578-18 E-16-2
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30.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.
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| ASTM E1578-18 E-16-3
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30.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.
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| ASTM E1578-18 E-16-4
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30.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.
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ASTM E1578-18 E-16-5
NIST 800-53, Rev. 5, MA-6(2)
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30.5 The system should support predictive maintenance routines for laboratory instruments and equipment.
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| ASTM E1578-18 E-16-6
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30.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.
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| ASTM E1578-18 E-16-7
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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.
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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)
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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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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
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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.
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42 CFR Part 493.1252
ASTM E1578-18 E-16-10
ISO 15189:2012 5.10.3
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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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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
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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.
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