quality-documentation-manager - Manage medical device quality documents
Manages document numbering, lifecycle control, review and approval, change control, and electronic record and signature compliance for medical device QMS documents.
Tags
Updated: 2026-09-30Capabilities
Typical Inputs
Typical Outputs
What this skill does
- Assign document numbers
- Control document lifecycles
- Route documents for review
- Manage approval signatures
- Process document changes
- Assess change impacts
- Maintain change histories
- Implement audit trails
- Control electronic signatures
Inputs
- Document type
- Document category
- Document content
- Review comments
- Approval requirements
- Change request justification
- Change classification
- Impact assessment data
- Electronic record requirements
Outputs
- Assigned document number
- Reviewed document
- Approved document
- Updated document master list
- Change control record
- Document revision history
- Audit trail
- Electronic signature record
- Document lifecycle status
Requirements
- Document control procedure
- Controlled document template
- Document management system or routing form
- Authorized reviewers and approvers
- Access-controlled electronic system