Template:LIMSpec/Scientific data management

Regulation, Specification, or Guidance Requirement ASTM E1578-18 E-11-1 EPA ERLN Laboratory Requirements 4.3.4.1 EPA ERLN Laboratory Requirements 4.8.9 EPA ERLN Laboratory Requirements 4.9.9 24.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP/IP communication. ASTM E1578-18 E-11-2 24.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access. ASTM E1578-18 E-11-1 EPA ERLN Laboratory Requirements 4.3.4.1 EPA ERLN Laboratory Requirements 4.8.9 EPA ERLN Laboratory Requirements 4.9.9 24.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve. ASTM E1578-18 E-11-4 24.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data. AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3 ASTM E1578-18 E-11-5 EPA ERLN Laboratory Requirements 4.3.4.1 EPA ERLN Laboratory Requirements 4.8.9 EPA ERLN Laboratory Requirements 4.9.9 24.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software. ASTM E1578-18 E-11-6 24.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles. ASTM E1578-18 E-11-7 24.7 The SDMS shall provide security and access controls for protecting stored data. ASTM E1578-18 E-11-8 24.8 The SDMS shall record an audit trail for each and every record created and modified, using version control. 45 CFR Part 164.308 ASTM E1578-18 E-11-9 24.9 The SDMS shall record an audit trail for each and every record created and modified, using version control.