Template:LIMSpec/Data integrity

Regulation, Specification, or Guidance Requirement ASTM E1578-18 E-17-1 EMA Guidance on Good Manufacturing Practice and Good Distribution Practice WHO Technical Report Series, #996, Annex 5, 9.1 31.1 System functionality should support ALCOA principles. ASTM E1578-18 E-17-2 EPA 815-R-05-004 Chap. IV, Sec. 8 A2LA C211 4.13.2.3 EMA Guidance on Good Manufacturing Practice and Good Distribution Practice EPA ERLN Laboratory Requirements 4.8.6 EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7 NIST 800-53, Rev. 5, SI-12 31.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review. ASTM E1578-18 E-17-3 21 CFR Part 58.190 42 CFR Part 93.305 42 CFR Part 93.310 CLSI QMS22 2.2.2.2 EMA Guidance on Good Manufacturing Practice and Good Distribution Practice EPA 815-R-05-004 Chap. IV, Sec. 8 EPA ERLN Laboratory Requirements 4.3.4.1 EPA ERLN Laboratory Requirements 4.8.6 EPA ERLN Laboratory Requirements 4.8.9 EPA ERLN Laboratory Requirements 4.9.9 NIST 800-53, Rev. 5, SI-12 OECD GLP Principles 10 PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3) USDA Administrative Procedures for the PDP 5.2.1 USDA Data and Instrumentation for PDP 8.1.3 WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1 31.3 The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review. 7 CFR Part 91.30 7 CFR Part 331.17 (c) 9 CFR Part 2.35 9 CFR Part 121.17 (c) 10 CFR Part 20.2103–10 10 CFR Part 30.34 (g) 10 CFR Part 30.51–2 21 CFR Part 11.10 (c) 21 CFR Part 58.195 21 CFR Part 211.180 21 CFR Part 212.110 (c) 21 CFR Part 225.42 (b-8) 21 CFR Part 225.58 (c–d) 21 CFR Part 225.102 21 CFR Part 225.110 21 CFR Part 225.158 21 CFR Part 225.202 21 CFR Part 226.42 (a) 21 CFR Part 226.58 (f) 21 CFR Part 226.102 21 CFR Part 226.115 21 CFR Part 312.57 21 CFR Part 312.62 21 CFR Part 606.160 (d) 21 CFR Part 812.140 (d) 21 CFR Part 820.180 (b) 29 CFR Part 1910.120 (f)(8) 29 CFR Part 1910.1030 (h-2) 40 CFR Part 141.33 40 CFR Part 141.722 40 CFR Part 262.11 (f) 40 CFR Part 262.40 40 CFR Part 262.213 40 CFR Part 704 Subpart A 40 CFR Part 717.15 (d) 42 CFR Part 73.17 (c) 42 CFR Part 93.313 (h) 42 CFR Part 93.317 42 CFR Part 493.1105 42 CFR Part 493.1283 45 CFR Part 164.105 45 CFR Part 164.316 45 CFR Part 164.530 A2LA C223 5.4 A2LA C223 5.9 AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1 AAVLD Requirements for an AVMDL Sec. 4.10.1.2 AAVLD Requirements for an AVMDL Sec. 4.10.2.1 AAVLD Requirements for an AVMDL Sec. 5.4.3.2 ABFT Accreditation Manual Sec. E-33 ACMG Technical Standards for Clinical Genetics Laboratories C1.5 ACMG Technical Standards for Clinical Genetics Laboratories C5.6 ACMG Technical Standards for Clinical Genetics Laboratories E2.1 AIHA-LAP Policies 2022 2A.7.5.1 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7 ASTM E1578-18 E-17-4 CAP Laboratory Accreditation Manual CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition CJIS Security Policy 5.3.4 CJIS Security Policy 5.4.6–7 CJIS Security Policy 5.5.2.1 CLSI QMS22 2.8.3 EMA Guidance on Good Manufacturing Practice and Good Distribution Practice E.U. Annex 11-7.1 E.U. Commission Directive 2003/94/EC Article 9.1 E.U. Commission Directive 2003/94/EC Article 11.4 EPA 815-R-05-004 Chap. III, Sec. 15 EPA 815-R-05-004 Chap. IV, Sec. 8 EPA ERLN Laboratory Requirements 4.9.18 EPA ERLN Laboratory Requirements 4.11.17 EPA QA/G-5 2.1.9 ICH GCP 4.9.5 ISO 15189:2012 4.3 ISO/IEC 17025:2017 8.4.2 NIST 800-53, Rev. 5, AT-4 NIST 800-53, Rev. 5, AU-11 and AU-11(1) NIST 800-53, Rev. 5, SI-12 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards OECD GLP Principles 10 OSHA 1910.1020(d)(1)(i–ii) OSHA 1910.1450(j)(2) PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (throughout) USDA Administrative Procedures for the PDP 5.4 USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2 USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c USDA Sampling Procedures for PDP 6.5 WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4 WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0 WHO Technical Report Series, #986, Annex 2, 15.8–9 WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1 31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period. ASTM E1578-18 E-17-6 CJIS Security Policy 5.4.4 NIST 800-53, Rev. 5, AU-8 WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1 31.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps. APHL 2019 LIS Project Management Guidebook ASTM E1578-18 E-17-7 CJIS Security Policy 5.6.1 31.6 The system shall require each and every user to be assigned a unique user ID. ASTM E1578-18 E-17-8 21 CFR Part 11.10 (e) CJIS Security Policy 5.4.5 E.U. Annex 11-9 NIST 800-53, Rev. 5, AU-9 31.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts. CJIS Security Policy 5.4.2 NIST 800-53, Rev. 5, AU-5 NIST 800-53, Rev. 5, SI-4 31.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.