quality-documentation-manager

QMS document control for ISO 13485 compliance is managed by handling document numbering, version control, change management, and approval workflows. This framework ensures regulatory adherence throughout the document lifecycle from creation to obsolescence.

To enforce 21 CFR Part 11 electronic signature requirements for SOPs, you implement validation scripts and approval workflows. This ensures Standard Operating Procedures are properly versioned, approved, and compliant with FDA regulations before a product launch.

Yes, the medical device documentation manager validates PDF compliance files using Python scripts with pypdf, pdfplumber, and pdf2image. These dependencies extract and validate document metadata to ensure QMS regulatory adherence.

The best way to automate change management for medical device QMS documents is using Python validation scripts alongside structured reference procedures. This combination enforces document numbering, version control, and electronic signature compliance.

To validate document metadata for a specific SOP file, you run the quality-documentation-manager skill against the target JSON file. This checks the Standard Operating Procedure metadata to ensure it meets ISO 13485 and 21 CFR Part 11 regulatory standards.