User:Shawndouglas/sandbox/sublevel8

1.1 Sample/Experiment Registration

Regulation, Specification, or Guidance Requirement 42 CFR Part 493.1241 ASTM E1578-18 C-1-1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection. 21 CFR Part 58.105 (c) 21 CFR Part 211.84 21 CFR Part 211.101 21 CFR Part 226.80 21 CFR Part 606.120 (b) 21 CFR Part 606.121 (c–i) 21 CFR Part 606.140 (c) 29 CFR Part 1910.1030 (g) 29 CFR Part 1910.1096 (e1-6) 42 CFR Part 493.1232 ABFT Accreditation Manual Sec. D ASTM E1492-11 4.1.1.6 ASTM E1578-18 C-1-2 EPA ERLN Laboratory Requirements 3.2.2 EPA QA/G-5 2.2.3 E.U. Commission Directive 2003/94/EC Article 15 OECD GLP Principles 6.1 USDA Sampling Procedures for PDP 6.4.1.2.6 WHO Technical Report Series, #986, Annex 2, 17.11 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support. 45 CFR Part 162.410 CJIS Security Policy 5.6.1 The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities. 42 CFR Part 493.1241 ASTM E1578-18 C-1-3 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services. ASTM E1578-18 C-1-4 USDA Sampling Procedures for PDP 6.4.1.1.3 The system should permit metadata like lot number, client demographics, sampling point, random selection process used, and industry-specific items to be included during registration.