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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. ASTM E1578-18 C-1-5 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests. ASTM E1578-18 C-1-6 The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry. ASTM E1578-18 C-1-7 The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples. 7 CFR Part 331.17 9 CFR Part 121.17 21 CFR Part 58.105 (c) 21 CFR Part 58.195 21 CFR Part 211.84 21 CFR Part 211.170 21 CFR Part 211.194 21 CFR Part 312.57 (d) 40 CFR Part 141.33 42 CFR Part 73.17 42 CFR Part 493.1105 42 CFR Part 493.1241 42 CFR Part 493.1242 42 CFR Part 493.1274 (f) 42 CFR Part 493.1283 AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.2–3 AAVLD Requirements for an AVMDL Sec. 5.7.1.2 ABFT Accreditation Manual Sec. D ASTM E1578-18 C-1-8 EPA 815-R-05-004 Chap. IV, Sec. 6 and 8 EPA 815-R-05-004 Chap. VI, Sec. 8 EPA ERLN Laboratory Requirements 3.2 EPA ERLN Laboratory Requirements 4.4.10–11 EPA ERLN Laboratory Requirements 4.7.1–6 EPA QA/G-5 2.2.2 and 2.2.3 E.U. Commission Directive 2003/94/EC Article 11.4 ISO 15189:2012 5.7.2 OECD GLP Principles 6.1 USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13 USDA Sampling Procedures for PDP 5.1 WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period. ASTM E1578-18 C-1-9 EPA ERLN Laboratory Requirements 3.2.1 EPA ERLN Laboratory Requirements 4.4.5 The system should allow for the addition of observations and descriptions to registered samples in the form of free text. ASTM E1578-18 C-1-10 The system should support the creation of user-definable default sample registration preferences and/or input screens. ASTM E1578-18 C-1-11 The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample. 21 CFR Part 58.107 (c) 21 CFR Part 211.194 42 CFR Part 493.1241 42 CFR Part 493.1274 42 CFR Part 493.1283 AAVLD Requirements for an AVMDL Sec. 5.8.2 ABFT Accreditation Manual D-3 ASTM E1578-18 C-1-12 EPA ERLN Laboratory Requirements 3.2.2 EPA ERLN Laboratory Requirements 4.1.11 EPA ERLN Laboratory Requirements 4.4.10 EPA QA/G-5 2.2.3 E.U. Commission Directive 2003/94/EC Article 15 ISO/IEC 17025:2017 7.4.2 OECD GLP Principles 6.2 USDA Sample Processing and Analysis Procedures for PDP 5.1.11 USDA Sampling Procedures for PDP 6.4.1.2.5 WHO Technical Report Series, #986, Annex 2, 17.11 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format. 7 CFR Part 331.17 9 CFR Part 121.17 21 CFR Part 58.107 (d) 21 CFR Part 211.194 42 CFR Part 73.17 ASTM E1578-18 C-1-13 EPA ERLN Laboratory Requirements 4.4.7 EPA QA/G-5 2.2.3 OECD GLP Principles 6.1 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception. ASTM E1578-18 C-1-14 EPA ERLN Laboratory Requirements 4.4.6 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements. AAVLD Requirements for an AVMDL Sec. 5.8.3 ASTM E1492-11 4.1.1.5 ASTM E1492-11 4.1.6 ASTM E1492-11 4.3.3.2 ASTM E1578-18 C-1-15 EPA ERLN Laboratory Requirements 4.4.13 EPA ERLN Laboratory Requirements 4.11.8 USDA Sample Processing and Analysis Procedures for PDP 5.1.3–7 USDA Sampling Procedures for PDP 6.4.1.1.9 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample. ASTM E1578-18 C-1-16 EPA QA/G-5 2.2.2 and 2.2.3 The system should provide a means to document sample preparation activities for a given sample. 7 CFR Part 331.11 7 CFR Part 331.17 9 CFR Part 121.11 9 CFR Part 121.17 42 CFR Part 73.11 42 CFR Part 73.17 42 CFR Part 493.1274 ABFT Accreditation Manual Sec. D-9–10 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1 ASTM E1492-11 (throughout) ASTM E1578-18 C-1-17 EPA 815-R-05-004 Chap. III, Sec. 12 EPA 815-R-05-004 Appendix A EPA ERLN Laboratory Requirements 3.2.3–5 EPA ERLN Laboratory Requirements 4.1.13 EPA ERLN Laboratory Requirements 4.4.8–9 EPA QA/G-5 2.2.3 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel—including details such as unique identifier, name, location, date, and time—while the sample is in the laboratory’s possession.