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Regulation, Specification, or Guidance
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Requirement
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▪ 21 CFR Part 312.62 (b) ▪ 21 CFR Part 812.140 (a-3)
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16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.
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▪ 21 CFR Part 312.57 (a)
▪ 21 CFR Part 312.62 (a)
▪ 21 CFR Part 606.165
▪ 21 CFR Part 812.140 (a-2) and (b-2)
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16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.
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▪ 21 CFR Part 58.81 (a)
▪ 21 CFR Part 211.100
▪ 21 CFR Part 211.111
▪ 21 CFR Part 211.192
▪ 21 CFR Part 211.194
▪ 21 CFR Part 606.171
▪ 42 CFR Part 493.1253 (b-2)
▪ ABFT Accreditation Manual C-16
▪ ABFT Accreditation Manual F-2
▪ ABFT Accreditation Manual J-3
▪ ASTM E1578-18 E-9-1
▪ EPA ERLN Laboratory Requirements 3.3
▪ EPA QA/G-5 2.2.4
▪ ISO/IEC 17025:2017 7.2.1.7
▪ ISO/IEC 17025:2017 7.2.2.1
▪ ISO/IEC 17025:2017 7.10.2
▪ ISO/IEC 17025:2017 8.7.1
▪ OECD GLP Principles 7.3
▪ USDA Administrative Procedures for the PDP 8.2.2
▪ WHO Technical Report Series, #986, Annex 2, 16.3
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16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
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▪ 42 CFR Part 493.1282 ▪ ASTM E1578-18 E-9-2
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16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.
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▪ 21 CFR Part 606.100 (c)
▪ 42 CFR Part 493.1282
▪ ASTM E1578-18 E-9-3
▪ EPA QA/G-5 2.2.10
▪ WHO Technical Report Series, #986, Annex 2, 17.12
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16.5 The system should trigger an alert or notification when an OOS/OOT status is found, prompting a documented investigation to identify the root cause.
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▪ 21 CFR Part 225.58 (d)
▪ 21 CFR Part 225.158
▪ 21 CFR Part 606.100 (c)
▪ 21 CFR Part 820.100
▪ 42 CFR Part 493.1282
▪ ASTM E1578-18 E-9-4
▪ E.U. Commission Directive 2003/94/EC Article 13
▪ FDA Hazard Analysis Critical Control Point Principle 5
▪ New York Department of Health ELAP Microbiology Protocol
▪ NIST 800-53, Rev. 4, IR-5
▪ WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)
▪ WHO Technical Report Series, #986, Annex 2, 5.0
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16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
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▪ 21 CFR Part 225.58 (d)
▪ 21 CFR Part 225.158
▪ 42 CFR Part 493.1282
▪ 42 CFR Part 493.1289
▪ ASTM E1578-18 E-9-5
▪ CJIS Security Policy 5.3.4
▪ CJIS Security Policy Appendix G.7
▪ E.U. Commission Directive 2003/94/EC Article 13
▪ FDA Hazard Analysis Critical Control Point Principle 5
▪ New York Department of Health ELAP Microbiology Protocol
▪ NIST 800-53, Rev. 4, AU-6(1)
▪ NIST 800-53, Rev. 4, IR-4(1) and IR-5
▪ NIST 800-53, Rev. 4, SI-2 and SI-4
▪ WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)
▪ WHO Technical Report Series, #986, Annex 2, 5.0
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16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.
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▪ ASTM E1578-18 E-9-6
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16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.
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