Implementation

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4. Results Review and Verification

Regulation, Specification, or Guidance Requirement

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

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
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

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
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

4.3 The system shall accurately maintain a full audit trail for modified results.

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

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

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.

5. Sample, Experiment, and Study Approval and Verification

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-5-1
USDA Sample Processing and Analysis Procedures for PDP 5.9–10
5.1 The system shall accurately record details of a sample's final disposition.
AIHA-LAP Policies 2018 2A.7.7.2
ASTM E1578-18 C-5-2
5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.
21 CFR Part 211.160 (b)
ASTM E1578-18 C-5-3
EPA 815-R-05-004 Chap. IV, Sec. 6.1
5.3 The system should provide appropriate functions for specific sample statuses like "approved" and "rejected," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.

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