21 CFR Part 11.10 (e)
21 CFR Part 11.70
21 CFR Part 58.130 (e)
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 E-2-2
CJIS Security Policy 5.4.1.1
CJIS Security Policy Appendix G.5
EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
E.U. Annex 11-9
E.U. Annex 11-12.4
E.U. Annex 11-14
E.U. Commission Directive 2003/94/EC Article 9.2
NIST 800-53, Rev. 4, AC-2(4) and AC-6(9)
NIST 800-53, Rev. 4, AU-2 and AU-3
NIST 800-53, Rev. 4, CM-5(1)
OECD GLP Principles 8.3.5
WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9
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9.2 The system shall document in the audit trail any event—including administrative and privileged functions—that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.
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ISO/IEC 17025:2017
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9.8 The system should support a laboratory's ISO/IEC 17025:2017 compliance efforts. (See LIMSpec for Cannabis Testing 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO/IEC 17025:2017-supported requirements.)
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