Template:LIMSpec/Document management

Regulation, Specification, or Guidance Requirement 7 CFR Part 331 (throughout) 9 CFR Part 121 (throughout) 10 CFR Part 20 (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) 40 CFR Part 262.213–14 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) A2LA C211 4.3 A2LA C223 4.13 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 CAP Laboratory Accreditation Manual (throughout) CJIS Security Policy (throughout) EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (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 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards NYSDOH ELAP Medical Marijuana Microbiology Guidance NIST 800-53, Rev. 5 (throughout) OECD GLP Principles 8 OSHA 1910.1200(b)(3) OSHA 1910.1450(e) and (h) PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (throughout) 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, #961, Annex 13 (throughout) WHO Technical Report Series, #986, Annex 2 (throughout) WHO Technical Report Series, #996, Annex 5 (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) 40 CFR Part 262.214 42 CFR Part 73 (throughout) 42 CFR Part 93.300–5 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) A2LA C211 (throughout) A2LA C223 (throughout) AAFCO QA/QC Guidelines for Feed Laboratories (throughout) AAVLD Requirements for an AVMDL (throughout) ACMG Technical Standards for Clinical Genetics Laboratories (throughout) AIHA-LAP Policies 2022 Appendix H5.8 ASTM E1188-11 3.5.2 ASTM E1492-11 4.3.3.3 and 4.4.4 ASTM E1578-18 D-1-2 CAP Laboratory Accreditation Manual (throughout) CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout) CJIS Security Policy (throughout) CLSI QMS22 (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) NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards NYSDOH ELAP Medical Marijuana Microbiology Guidance NIST 800-53, Rev. 5 (throughout) OECD GLP Principles 8 OSHA 1910.1020 (throughout) OSHA 1910.1200(b)(3) OSHA 1910.1450(h) PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (throughout) USDA Administrative Procedures for the PDP (throughout) USDA Data and Instrumentation for PDP (throughout) USDA Hemp Production Program Laboratory Testing Guidelines (throughout) USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3 USDA Sample Processing and Analysis Procedures for PDP (throughout) WADA International Standard for Laboratories (ISL) (throughout) WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout) WHO Technical Report Series, #961, Annex 13 (throughout) WHO Technical Report Series, #986, Annex 2 (throughout) WHO Technical Report Series, #996, Annex 5 (throughout) 7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials. 21 CFR Part 820.40 (a) 42 CFR Part 493.1251 (e) A2LA C211 4.3 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 211.160 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 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards NYSDOH ELAP Medical Marijuana Microbiology Guidance PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4) USDA Administrative Procedures for the PDP 8.4 USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2 USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3 WADA International Standard for Laboratories (ISL) 4.2.1 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) A2LA C211 5.4.5 A2LA C223 5.4 AAVLD Requirements for an AVMDL Sec. 5.4.2.4 ABFT Accreditation Manual Sec. G-12, -14, and -15 ACMG Technical Standards for Clinical Genetics Laboratories C10 ACMG Technical Standards for Clinical Genetics Laboratories F7.3 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 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards NYSDOH ELAP Medical Marijuana Microbiology Guidance PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3) USDA Administrative Procedures for the PDP 8.4 USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6 WHO Technical Report Series, #961, Annex 13, 10.1 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 2.32 9 CFR Part 121.10 9 CFR Part 121.15 10 CFR Part 30.34 (j-3) 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) 40 CFR Part 262.207 40 CFR Part 262.210–12 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 A2LA C211 5.2 A2LA C223 5.2 A2LA C223 5.7 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 ACMG Technical Standards for Clinical Genetics Laboratories B3–B5 ACMG Technical Standards for Clinical Genetics Laboratories C6.4 AIHA-LAP Policies 2022 (throughout) 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 CAP Laboratory Accreditation Manual CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition CLSI QMS22 (throughout) 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 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards NYSDOH ELAP Medical Marijuana Microbiology Guidance OECD GLP Principles 1.1.2 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 6.1 WADA International Standard for Laboratories (ISL) 5.2.2 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. APHL 2019 LIS Project Management Guidebook 7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.