User:Shawndouglas/sandbox/sublevel12

8. Resource Management

Regulation, Specification, or Guidance Requirement 29 CFR Part 1910.120 29 CFR Part 1910.134 (m) 29 CFR Part 1910.1030 (h-1) 29 CFR Part 1910.1450 (j) CJIS Security Policy 5.2.3 EPA ERLN Laboratory Requirements 4.2.4.1 EPA QA/G-5 2.1.8 USDA Administrative Procedures for the PDP 6.1 USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3 8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure. 21 CFR Part 820.198 42 CFR Part 493.1233 E.U. Commission Directive 2003/94/EC Article 13 WHO Technical Report Series, #986, Annex 2, 2.1 (j) WHO Technical Report Series, #986, Annex 2, 5.0 8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility. 7 CFR Part 331.15 9 CFR Part 121.15 21 CFR Part 211.25 29 CFR Part 1910.1450 (f) 42 CFR Part 73.15 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 ASTM E1578-18 E-1-1 CJIS Security Policy 5.2.1 EPA ERLN Laboratory Requirements 4.2.4.1 FDA Hazard Analysis Critical Control Point Guidelines USDA Sampling Procedures for PDP 6.1.2–3 WHO Technical Report Series, #986, Annex 2, 10 8.3 The system shall allow training sessions to be scheduled for personnel. 29 CFR Part 1910.1450 (f) ABFT Accreditation Manual Sec. B ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7 ASTM E1578-18 E-1-2 FDA Hazard Analysis Critical Control Point Guidelines 8.4 The system should provide access to relevant training materials to personnel attending training sessions. 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 5.2.1.1–3 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5 ASTM E1578-18 E-1-3 29 CFR Part 1910.1450 (f) CJIS Security Policy 5.2.3 EPA ERLN Laboratory Requirements 4.2.4.1 EPA QA/G-5 2.1.8 E.U. Commission Directive 2003/94/EC Article 7.4 FDA Hazard Analysis Critical Control Point Guidelines [ISO 15189:2012 5.1.9 USDA Administrative Procedures for the PDP 6.1 USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3 WHO Technical Report Series, #986, Annex 2, 2.1 (e) WHO Technical Report Series, #986, Annex 2, 9.4 WHO Technical Report Series, #986, Annex 2, 10 8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification. ABFT Accreditation Manual Sec. B ASTM E1578-18 E-1-4 8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference. ASTM E1578-18 E-1-5 8.7 The system should be able to produce a training matrix of personnel. 7 CFR Part 331.15 9 CFR Part 121.10 9 CFR Part 121.15 21 CFR Part 11.10 (i) 21 CFR Part 58.29 21 CFR Part 211.25 21 CFR Part 225.10 21 CFR Part 226.10 21 CFR Part 226.40 21 CFR Part 820.25 29 CFR Part 1910.1030 (g-2) 29 CFR Part 1910.1030 (h-2) 29 CFR Part 1910.1200 (h) 29 CFR Part 1910.1450 (e) 42 CFR Part 73.10 42 CFR Part 73.15 42 CFR Part 493.43 (c) 42 CFR Part 493.1235 45 CFR Part 164.308 45 CFR Part 164.530 AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6 AAVLD Requirements for an AVMDL Sec. 5.2 AAVLD Requirements for an AVMDL Sec. 5.4.2.2 AAVLD Requirements for an AVMDL Appendix 1 ABFT Accreditation Manual Sec. B AIHA-LAP Policies 2018 (various parts) 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 5.2.1.1–3 ASTM E1578-18 C-3-5 ASTM E1578-18 D-1-6 ASTM E1578-18 E-1-6 E.U. Annex 11-2 EPA 815-R-05-004 Chap. III, Sec. 10 and 17 EPA 815-R-05-004 Chap. IV, Sec. 1 EPA QA/G-5 2.1.8 ISO 15189:2012 4.1.2.1 ISO 15189:2012 5.1.6 ISO 15189:2012 5.1.9 ISO/IEC 17025:2017 6.2.2 ISO/IEC 17025:2017 6.2.3 ISO/IEC 17025:2017 6.2.5 ISO/IEC 17025:2017 6.2.6 OECD GLP Principles 1.1.2 USDA Administrative Procedures for the PDP 6.1 8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.

9. Compliance Management

Regulation, Specification, or Guidance Requirement 7 CFR Part 331.17 9 CFR Part 121.17 21 CFR Part 11.10 (e) 21 CFR Part 11.70 21 CFR Part 58.130 (e) 42 CFR Part 73.17 42 CFR Part 493.1251 (d) ASTM E1578-18 C-4-7 ASTM E1578-18 E-2-1 EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7 E.U. Annex 11-9 E.U. Annex 11-14 OECD GLP Principles 8.3.5 USDA Data and Instrumentation for PDP 8.1.3 9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record. 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 OECD GLP Principles 8.3.5 WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9 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. 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 42 CFR Part 493.1274 45 CFR Part 170.315 (d) ASTM E1578-18 E-2-3 CJIS Security Policy 5.4.1.1 E.U. Annex 11-12.4 E.U. Annex 11-14 E.U. Commission Directive 2003/94/EC Article 9.2 OECD GLP Principles 8.3.5 USDA Data and Instrumentation for PDP 8.1.4 WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9 9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed. 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-2-4 EPA ERLN Laboratory Requirements 4.8.6 E.U. Annex 11-14 E.U. Commission Directive 2003/94/EC Article 9.2 OECD GLP Principles 8.3.5 WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9 9.4 The system's audit trail shall document the previous and current value of a modified field. 21 CFR Part 11.10 (e) 21 CFR Part 11.70 21 CFR Part 58.130 (e) 21 CFR Part 211.194 42 CFR Part 493.1251 (d) 45 CFR Part 164.310 ASTM E1578-18 E-2-5 EPA ERLN Laboratory Requirements 4.8.6 E.U. Annex 11-14 OECD GLP Principles 8.3.5 9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record. 21 CFR Part 11.70 E.U. Annex 11-14 9.6 The system shall prevent a user from copying and pasting the electronic signature of another user. 21 CFR Part 11.10 (e) 21 CFR Part 58.130 (e) 42 CFR Part 493.1274 (d) E.U. Annex 11-9 OECD GLP Principles 8.3.5 9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.