Manages medical device Quality Management System (QMS) documentation and regulatory compliance workflows.
This skill provides a comprehensive framework for managing document control systems within highly regulated medical device environments. It streamlines the creation, numbering, review, and approval of documents in accordance with ISO 13485 and FDA 21 CFR Part 11. By providing standardized workflows for change control, impact assessments, and electronic signature management, it ensures that your technical documentation remains audit-ready and compliant throughout the entire product lifecycle.
主な機能
01Standardized document numbering and versioning conventions
02Rigorous change control workflows with automated impact assessments
03Validation tools for document metadata and master list integrity
0421 CFR Part 11 compliance checking for electronic records and signatures
050 GitHub stars
06Multi-stage document lifecycle management from draft to obsolescence
ユースケース
01Establishing a compliant document control system for ISO 13485 certification
02Executing formal change requests for technical specifications and SOPs
03Auditing electronic signature manifests and audit trails for FDA compliance
