quality-documentation-manager

Document control for an ISO 13485 Quality Management System is managed by enforcing standardized document numbering, tracking version control, and guiding controlled document lifecycle stages from drafting to approval.

21 CFR Part 11 compliance for electronic records is ensured by maintaining audit trails and enforcing systematic review and approval workflows for quality documentation changes within regulated medical device environments.

Change management for FDA-regulated Standard Operating Procedures is handled by facilitating systematic review, guiding approval processes, and updating version control to meet all regulatory requirements.

Yes, you can maintain audit trails for medical device regulatory documentation, as the system explicitly supports audit trail maintenance and controlled document lifecycle management for FDA and ISO 13485 requirements.

Yes, PDF processing libraries like pypdf, pdfplumber, and pdf2image are required dependencies to parse, extract, and review text and images from controlled QMS documents during regulatory documentation checks.