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26. Systems Integration

Regulation, Specification, or Guidance Requirement 21 CFR Part 211.105 (a) ASTM E1578-18 E-13-1 26.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems. ASTM E1578-18 E-13-2 26.2 The system should accurately communicate status changes to external systems. 21 CFR Part 11.10 (c) 21 CFR Part 58.190 ABFT Accreditation Manual C-15 ASTM E1578-18 E-13-3 EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14 ISO/IEC 17025:2017 8.4.2 OECD GLP Principles 3.4 OECD GLP Principles 10 USDA Administrative Procedures for the PDP 5.5 26.3 The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.