quality-documentation-manager

ISO 13485 document control is maintained by automating document numbering, version control, and change control workflows. This ensures traceable changes and electronic records while tracking documents from draft through obsolescence.

21 CFR Part 11 compliance is managed by applying electronic signature workflows and access controls to regulatory records. This satisfies audit trail and validation requirements for medical device quality management systems.

Change control workflows for SOPs and technical files are set up by uploading an initial document to begin version-controlled tracking. The system manages approval signatures aligned with regulatory requirements throughout the process.

Audit trail tracking from draft to obsolescence is fully supported. The system applies document numbering and master list management to ensure traceable changes and auditable history for procedures and regulatory records.

Managing technical files and work instructions alongside SOPs is supported. The system standardizes quality documentation management across procedures, changes, and regulatory records with compliant version control.

Medical device quality management requires automated version control to reduce the risk of misnumbered or misapproved documents. This ensures traceable changes and standardized electronic records for regulatory compliance.