What problem does it solve? Medical device quality teams struggle to maintain ISO 13485-compliant document control: consistent numbering, approval routing, change history, and FDA 21 CFR Part 11 electronic record requirements. This Skill provides structured procedures and a validation script to keep controlled documents audit-ready. ## Core Features & Use Cases - Document Control Workflows: Defines numbering conventions (PREFIX-CATEGORY-SEQUENCE-REVISION), lifecycle stages from Draft to Obsolete, approval matrices, and periodic review schedules. - Change Control Management: Classifies changes as Administrative, Minor, Major, or Emergency with impact assessment checklists covering training, validation, and regulatory effects. - 21 CFR Part 11 Compliance: Details electronic record controls, audit trail requirements, two-component electronic signatures, and system validation guidance. - Automated Validation: The document_validator.py script checks document metadata against numbering, approval, change history, and Part 11 rules, producing a compliance score. - Use Case: A QA manager preparing for an ISO 13485 audit validates all SOPs against the numbering standard, confirms approval signatures exist, and verifies audit trail controls before the auditor arrives. ## Quick Start Ask the assistant to validate a controlled document's metadata for ISO 13485 and 21 CFR Part 11 compliance using the document validator script.
