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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 1.1152 (c)
▪ 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)
▪ A2LA C211 5.4
▪ ABFT Accreditation Manual C-16
▪ ABFT Accreditation Manual F-2
▪ ABFT Accreditation Manual J-3
▪ ASTM E1578-18 E-9-1
▪ BRC GSFS, Issue 8, 5.6.2.3
▪ BRC GSFS, Issue 8, 9.3.4
▪ CLSI QMS22 2.2.2.2
▪ EPA ERLN Laboratory Requirements 3.3
▪ EPA QA/G-5 2.2.4
▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1
▪ 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
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ OECD GLP Principles 7.3
▪ PFP Human and Animal Food Testing Laboratories Best Practices Manual
▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)
▪ USDA Administrative Procedures for the PDP 8.2.2
▪ WADA International Standard for Laboratories (ISL) 5.3.6
▪ 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
▪ E.U. Commission Reg. No. 2073/2005 Article 9
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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
▪ CLSI QMS22 2.1.2.1
▪ CLSI QMS22 2.2.2.3
▪ EPA QA/G-5 2.2.10
▪ WHO Technical Report Series, #986, Annex 2, 17.12
▪ WHO Technical Report Series, #996, Annex 5, 11.12
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16.5 The system should trigger an alert or notification when an OOS/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.
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▪ 10 CFR Part 30.34 (g)
▪ 21 CFR Part 112.147
▪ 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
▪ 61 FR 38806, 9 CFR Part 417.3
▪ A2LA C211 4.9 and 4.11
▪ ASTM E1578-18 E-9-4
▪ BRC GSFS, Issue 8, 3.4.3
▪ BRC GSFS, Issue 8, 5.6.1.2
▪ BRC GSFS, Issue 8, 9.3.5
▪ CLSI QMS22 2.6.4
▪ E.U. Commission Directive 2003/94/EC Article 13
▪ FDA Hazard Analysis Critical Control Point Principle 5
▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ NYSDOH ELAP Medical Marijuana Microbiology Guidance
▪ NIST 800-53, Rev. 5, IR-5
▪ PFP Human and Animal Food Testing Laboratories Best Practices Manual
▪ SQF FSC 9, Food Manufacturing, Part B, 2.5.3
▪ SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3
▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3
▪ TNI EL-V1-2016-Rev.2.1 (throughout)
▪ USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h
▪ WADA International Standard for Laboratories (ISL) 5.3.9
▪ WHO Technical Report Series, #961, Annex 13, 11.1
▪ WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)
▪ WHO Technical Report Series, #986, Annex 2, 5.0
▪ WHO Technical Report Series, #996, Annex 5, 11.12
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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
▪ 61 FR 38806, 9 CFR Part 417.3
▪ A2LA C211 4.8 and 4.11
▪ ASTM E1578-18 E-9-5
▪ BRC GSFS, Issue 8, 3.4.3
▪ BRC GSFS, Issue 8, 5.6.1.2
▪ BRC GSFS, Issue 8, 9.3.5
▪ CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition
▪ 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
▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22
▪ NYSDOH ELAP Medical Marijuana Microbiology Guidance
▪ NIST 800-53, Rev. 5, AU-6(1)
▪ NIST 800-53, Rev. 5, IR-4(1) and IR-5
▪ NIST 800-53, Rev. 5, SI-2 and SI-4
▪ SQF FSC 9, Food Manufacturing, Part B, 2.5.3
▪ SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3
▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3
▪ 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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| ▪ 9 CFR Part 2.35
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16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag/tattoo number of the animal, the animal's description, etc.
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