Template:LIMSpec/Document management

Regulation, Specification, or Guidance Requirement 7 CFR Part 331 (throughout) 9 CFR Part 121 (throughout) 21 CFR Part 7 (throughout) 21 CFR Part 58 (throughout) 21 CFR Part 211 (throughout) 21 CFR Part 212 (throughout) 21 CFR Part 225 (throughout) 21 CFR Part 226 (throughout) 21 CFR Part 312 (throughout) 21 CFR Part 606 (throughout) 21 CFR Part 810 (throughout) 21 CFR Part 812 (throughout) 21 CFR Part 820 (throughout) 29 CFR Part 1910.134 (throughout) 29 CFR Part 1910.1030 (throughout) 29 CFR Part 1910.1200 (throughout) 29 CFR Part 1910.1450 (throughout) 42 CFR Part 73 (throughout) 42 CFR Part 493.1200 42 CFR Part 493.1232 42 CFR Part 493.1239 42 CFR Part 493.1251 42 CFR Part 493.1291 (j) 45 CFR Part 164 (throughout) AAFCO QA/QC Guidelines for Feed Laboratories (throughout) AAVLD Requirements for an AVMDL (throughout) ABFT Accreditation Manual (throughout) ASTM E1188-11 3.5.2 ASTM E1492-11 4.3.3.3 and 4.4.4 ASTM E1578-18 D-1-1 CJIS Security Policy (throughout) EPA 815-R-05-004 (throughout) EPA ERLN Laboratory Requirements (throughout) EPA QA/G-5 (throughout) E.U. Commission Directive 2003/94/EC (throughout) FDA Hazard Analysis Critical Control Point (throughout) ISO 15189:2012 4.3 ISO 15189:2012 5.5.3 ISO 15189:2012 5.9.3 ISO/IEC 17025:2017 5.3 ISO/IEC 17025:2017 5.5 ISO/IEC 17025:2017 8.3.2 New York Department of Health ELAP Microbiology Protocol NIST 800-53, Rev. 4 (throughout) OECD GLP Principles 8 USDA Administrative Procedures for the PDP (throughout) USDA Data and Instrumentation for PDP (throughout) USDA Sample Processing and Analysis Procedures for PDP (throughout) WHO Technical Report Series, #986, Annex 2 (throughout) 7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls. 7 CFR Part 331 (throughout) 9 CFR Part 121 (throughout) 21 CFR Part 7 (throughout) 21 CFR Part 58 (throughout) 21 CFR Part 211 (throughout) 21 CFR Part 212 (throughout) 21 CFR Part 225 (throughout) 21 CFR Part 226 (throughout) 21 CFR Part 312 (throughout) 21 CFR Part 606 (throughout) 21 CFR Part 810 (throughout) 21 CFR Part 812 (throughout) 21 CFR Part 820 (throughout) 29 CFR Part 1910.134 (c) 29 CFR Part 1910.1030 (throughout) 29 CFR Part 1910.1200 (e) 29 CFR Part 1910.1450 (throughout) 42 CFR Part 73 (throughout) 42 CFR Part 493.1200 42 CFR Part 493.1232 42 CFR Part 493.1239 42 CFR Part 493.1251 42 CFR Part 493.1291 (j) 42 CFR Part 493.1773 (c–d) 45 CFR Part 160.310 45 CFR Part 164 (throughout) AAFCO QA/QC Guidelines for Feed Laboratories (throughout) AAVLD Requirements for an AVMDL (throughout) ASTM E1188-11 3.5.2 ASTM E1492-11 4.3.3.3 and 4.4.4 ASTM E1578-18 D-1-2 CJIS Security Policy (throughout) EPA 815-R-05-004 (throughout) EPA ERLN Laboratory Requirements (throughout) EPA QA/G-5 (throughout) E.U. Commission Directive 2003/94/EC (throughout) FDA Hazard Analysis Critical Control Point (throughout) ISO 15189:2012 (throughout) ISO/IEC 17025:2017 (throughout) New York Department of Health ELAP Microbiology Protocol NIST 800-53, Rev. 4 (throughout) OECD GLP Principles 8 USDA Administrative Procedures for the PDP (throughout) USDA Data and Instrumentation for PDP (throughout) USDA Sample Processing and Analysis Procedures for PDP (throughout) WHO Technical Report Series, #986, Annex 2 (throughout) 7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials. 21 CFR Part 820.40 (a) 42 CFR Part 493.1251 (e) AAVLD Requirements for an AVMDL Sec. 4.3 ASTM E1578-18 D-1-3 EPA 815-R-05-004 Chap. III, Sec. 11 EPA ERLN Laboratory Requirements 4.2.4.2 EPA QA/G-5 2.1.9 ISO 15189:2012 4.3 ISO 15189:2012 5.5.3 ISO 15189:2012 5.9.3 ISO/IEC 17025:2017 7.5.2 ISO/IEC 17025:2017 8.3.2 USDA Administrative Procedures for the PDP 5.5 WHO Technical Report Series, #986, Annex 2, 15.5 7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions. ASTM E1578-18 D-1-4 7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision. 21 CFR Part 211.21 (c) 21 CFR Part 212.20 (c) 21 CFR Part 212.60 (c) 21 CFR Part 226.58 (e) 21 CFR Part 820.250 (b) 42 CFR Part 493.43 (c) ASTM E1578-18 D-1-5 EPA 815-R-05-004 Chap. IV, Sec. 5 ISO/IEC 17025:2017 6.5 ISO/IEC 17025:2017 7.2.1.3 New York Department of Health ELAP Microbiology Protocol USDA Administrative Procedures for the PDP 8.4 WHO Technical Report Series, #986, Annex 2, 15.14 7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation. 21 CFR Part 212.20 (c) 21 CFR Part 212.70 (b) AAVLD Requirements for an AVMDL Sec. 5.4.2.4 ABFT Accreditation Manual Sec. G-12, -14, and -15 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4 EPA QA/G-5 2.2.4 ISO/IEC 17025:2017 7.2.2.1 New York Department of Health ELAP Microbiology Protocol USDA Administrative Procedures for the PDP 8.4 WHO Technical Report Series, #986, Annex 2, 4.11 WHO Technical Report Series, #986, Annex 2, 15.13 7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input. 7 CFR Part 331.10 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 1910.134 (c) 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 (f) 42 CFR Part 73.10 42 CFR Part 73.15 42 CFR Part 493.43 (c) 42 CFR Part 493.1235 42 CFR Part 493.1251 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 E.U. Commission Directive 2003/94/EC Article 7.4 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 New York Department of Health ELAP Microbiology Protocol OECD GLP Principles 1.1.2 USDA Administrative Procedures for the PDP 6.1 7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks. ASTM E1578-18 D-1-7 7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system. AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5 EPA ERLN Laboratory Requirements 4.10.6 7.9 The system shall support the addition of accurate cross-references and page numbers to new documents. AAVLD Requirements for an AVMDL Sec. 4.3.4 7.10 The system shall be capable of uniquely identifying documents created in and added to the system.