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Guidance and tooling for document control in regulated QMS: numbering, versioning, approval workflows, change control, and 21 CFR Part 11 e-record/e-signature c
Provides a complete document control framework for regulated quality management systems (ISO 13485 / FDA contexts). Covers numbering conventions, approval and review workflows, change control, audit-trail requirements, and Part 11/electronic signature controls, with validator tools to check document metadata.
Use when creating or maintaining SOPs, controlled documents, submission materials, or when implementing document-numbering, version-control, change-control, or Part 11 compliance for medical device QMS. Useful for regulatory authors, QA, and RA teams.
Best used by agents that can run validation scripts and edit documentation (Claude Code, Cursor, Codex, CI automation bots).
This skill has not been reviewed by our automated audit pipeline yet.
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