Map the system. Preserve the evidence. Test the handoff.
Source-backed reporting and analysis connected to the companies, capabilities, authorities, and operating domains it affects.
The current guidance frames confidence in production and quality-system software around intended use, risk, appropriate assurance activity, issues, and retained evidence—not documentation volume.
FDA's scope guidance requires a buyer to identify applicable predicate rules, electronic records, reliance, signatures, copies, and retention before evaluating controls.
The guidance connects complete data to metadata, audit trails, access, processing, review, investigation, and retained records across instruments and applications.
The official annex connects risk, suppliers, validation, operation, change, security, incidents, continuity, and archiving in one computerized-system lifecycle.
The regulator's publication page preserves its GxP guidance while noting that OECD Advisory Document No. 22 takes precedence for GLP data integrity.
The standard places software-supported records inside a wider system of impartiality, competence, resources, methods, equipment, sampling, handling, technical records, reporting, and improvement.
