quality-documentation-manager - Manage Medical Device Quality Documentation
Manages document numbering, lifecycle, reviews, approvals, change control, and electronic record and signature controls for medical device QMS documentation.
Tags
Updated: 2026-09-30Capabilities
Typical Inputs
Typical Outputs
What this skill does
- Assign document numbers
- Control document revisions
- Route document reviews
- Manage document approvals
- Process document changes
- Assess change impacts
- Implement audit trails
- Control electronic signatures
- Maintain document master lists
- Validate document accessibility
Inputs
- Document type
- Functional area
- Document content
- Review comments
- Approval requirements
- Change justification
- Impact assessment information
- Retention schedule
- Electronic record requirements
Outputs
- Assigned document number
- Revised controlled document
- Review comments
- Approval records
- Change request record
- Change history
- Document master list update
- Audit trail
- Electronic signature manifestation
- Document lifecycle status
Requirements
- ISO 13485-compliant QMS context
- Authorized document control access
- Electronic record system for Part 11 controls