|
|
| Regulation, Specification, or Guidance
|
Requirement
|
|
21 CFR Part 211.68 (b)
42 CFR Part 493.1241
ASTM E1578-18 C-4-1
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
|
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.
|
|
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
|
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.
|
|
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
|
4.3 The system shall accurately maintain a full audit trail for modified results.
|
|
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
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
ISO 15189:2012 5.7.1
ISO/IEC 17025:2017 7.8.1.1
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
|
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.
|
|
ASTM E1578-18 C-4-5
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
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
|
4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.
|
|
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
|
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.
|
CAP Laboratory Accreditation Manual
CLSI AUTO15 4.0
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
|
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 manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.
|
