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Regulation, Specification, or Guidance
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Requirement
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▪ 21 CFR Part 211.68 (b)
▪ 42 CFR Part 493.1241
▪ ASTM E1578-18 C-4-1
▪ BRC GSFS, Issue 8, 5.6.2.4
▪ CAP Laboratory Accreditation Manual
▪ CLSI QMS22 2.2.1.2
▪ EPA ERLN Laboratory Requirements 4.9.11
▪ EPA QA/G-5 2.4.1
▪ ISO 15189:2012 5.5.1.4
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ WHO Technical Report Series, #996, Annex 5, Appendix 1
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4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
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▪ ASTM E1578-18 C-4-2
▪ CLSI AUTO15 1.2
▪ EPA ERLN Laboratory Requirements 4.9.2
▪ EPA ERLN Laboratory Requirements 4.9.11
▪ EPA QA/G-5 2.4.1
▪ ISO 15189:2012 5.9.2
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
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4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.
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▪ 21 CFR Part 211.68
▪ 21 CFR Part 211.100
▪ 21 CFR Part 211.160 (a)
▪ 21 CFR Part 211.188
▪ 21 CFR Part 211.194
▪ 45 CFR Part 170.315 (d)
▪ ASTM E1578-18 C-4-3
▪ CAP Laboratory Accreditation Manual
▪ CJIS Security Policy 5.4.1.1
▪ CLSI QMS22 2.2.2.2
▪ EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
▪ E.U. Commission Directive 2003/94/EC Article 9.2
▪ ICH GCP 4.9.0 and 4.9.3
▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)
▪ WADA International Standard for Laboratories (ISL) 5.2.3.5
▪ WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9
▪ WHO Technical Report Series, #996, Annex 5, 4.12
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4.3 The system shall accurately maintain a full audit trail for modified results.
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▪ 21 CFR Part 1.1152 (c)
▪ 21 CFR Part 111.110
▪ 21 CFR Part 211.68 (b)
▪ A2LA C211 5.9.1
▪ A2LA C223 4.13
▪ ABFT Accreditation Manual Sec. E-28–29
▪ ACMG Technical Standards for Clinical Genetics Laboratories G15.1
▪ AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3
▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12
▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4–5
▪ ASTM E1578-18 C-4-4
▪ BRC GSFS, Issue 8, 5.6.2.4
▪ CAP Laboratory Accreditation Manual
▪ CLSI QMS22 2.2.2.2
▪ EPA ERLN Laboratory Requirements 3.2.6
▪ EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11
▪ EPA ERLN Laboratory Requirements 4.11.4
▪ EPA QA/G-5 2.2.10
▪ EPA QA/G-5 2.4.1
▪ E.U. Annex 11-6
▪ IFS Food 7, Part 2, 5.6.4
▪ IFS PACsecure 2, Part 2, 5.6.4
▪ ISO 15189:2012 5.7.1
▪ ISO/IEC 17025:2017 6.2.6
▪ ISO/IEC 17025:2017 7.7.1
▪ ISO/IEC 17025:2017 7.8.1.1
▪ NIST 800-53, Rev. 5, AU-10(3)
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ PFP Human and Animal Food Testing Laboratories Best Practices Manual
▪ USDA Data and Instrumentation for PDP 10
▪ WADA International Standard for Laboratories (ISL) 5.3.8.1
▪ WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1
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4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.
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▪ ASTM E1578-18 C-4-5
▪ BRC GSFS, Issue 8, 5.6.2.4
▪ BRC GSFS, Issue 8, 5.6.2.5
▪ EPA ERLN Laboratory Requirements 4.9.11
▪ EPA QA/G-5 2.2.10
▪ EPA QA/G-5 2.4.1
▪ E.U. Annex 11-6
▪ IFS Food 7, Part 2, 5.6.4
▪ IFS PACsecure 2, Part 2, 5.6.4
▪ ISO 15189:2012 5.9.2
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ WHO Technical Report Series, #996, Annex 5, Appendix 1
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4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.
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▪ ASTM E1578-18 C-4-6
▪ EPA QA/G-5 2.2.10
▪ EPA QA/G-5 2.4.1
▪ E.U. Annex 11-6
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4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.
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▪ CAP Laboratory Accreditation Manual
▪ CLSI AUTO15 4.0
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
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4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.
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