Regulatory Frameworks

Controls for electronic records and electronic signatures used to meet FDA requirements. Applicability depends on the underlying predicate rules and how regulated records are created, maintained, archived, retrieved, or transmitted.

Effective February 2, 2026, the Quality Management System Regulation incorporates ISO 13485:2016 by reference and adds FDA-specific provisions. FDA’s February 2026 CSA guidance connects software assurance to production and quality-management-system risk.

Lifecycle expectations for computerized systems used in GMP activities, including validation, data integrity, security, supplier oversight, continuity, change control, and periodic evaluation. The European Commission currently lists the January 2011 revision; 2025 consultation drafts are not final requirements.