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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).
Quality documentation manager for ISO 13485/21 CFR Part 11 medical device QMS. Two scripts: document_validator.py validates document metadata, numbering, and Part 11 compliance; document_version_control.py manages document lifecycle with versioning, approval workflows, and e-signatures. Both ran cleanly with no errors. SKILL.md is thorough and well-structured with clear triggers, tables, and regulatory references.
Clean, professional skill for a specialized regulatory domain. No security concerns whatsoever — pure local computation, no network calls, no credential handling. Scripts are well-written Python with proper dataclasses and error handling. The SKILL.md is comprehensive and references external reference docs. Narrow usefulness outside the medical device QMS domain.
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