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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
EPA ERLN Laboratory Requirements 4.9.11
EPA QA/G-5 2.4.1
ISO 15189:2012 5.5.1.4
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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
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
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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
CJIS Security Policy 5.4.1.1
EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
E.U. Commission Directive 2003/94/EC Article 9.2
WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9
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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 211.68 (b)
ABFT Accreditation Manual Sec. E-28–29
[AIHA-LAP Policies 2018 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
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
USDA Data and Instrumentation for PDP 10
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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
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
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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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