quality-documentation-manager
Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use when working on document control procedures, change control workflows, document numbering, version management, electronic signature compliance, or regulatory documentation review.
Profile →npx skills add alirezarezvani/claude-skills --skill quality-documentation-manager --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# Quality Documentation Manager Document control system design and management for ISO 13485-compliant quality management systems, including numbering conventions, approval workflows, change control, and electronic record compliance. --- ## Table of Contents - [Document Control Workflow](#document-control-workflow) - [Document Numbering System](#document-numbering-system) - [Approval and Review Process](#approval-and-review-process) - [Change Control Process](#change-control-process) - [21 CFR Part 11 Compliance](#21-cfr-part-11-compliance) - [Reference Documentation](#reference-documentation) - [Tools](#tools) --- ## Document Control Workflow Implement document control from creation through obsolescence: 1. Assign document number per numbering procedure 2. Create document using controlled template 3. Route for review to required reviewers 4. Address review comments and document responses 5. Obtain required approval signatures 6. Assign effective date and distribute 7. Update Document Master List 8. **Validation:** Document accessible at point of use; obsolete versions removed ### Document Lifecycle Stages | Stage | Definition | Actions Required | |-------|------------|-------------
- Table of Contents
- Document Control Workflow
- Document Lifecycle Stages
- Document Types and Prefixes
- Required Reviewers by Document Type
- Document Numbering System
- Numbering Format
- Category Codes
- Numbering Workflow
- Revision Designation
- Approval and Review Process
- Review Workflow
- Comment Disposition
- Approval Matrix
Validate document metadata python scripts/document_validator.py --doc document.json Interactive validation mode python scripts/document_validator.py --interactive JSON output for integration python scripts/document_validator.py --doc document.json --output json Generate sample document JSON python scripts/document_validator.py --sample > sample_doc.json
What does the quality-documentation-manager skill do?
Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use when working on document control procedures, change control workflows, document numbering, version management, electronic signature compliance, or regulatory documentation review.
How do I install it?
Run `npx skills add alirezarezvani/claude-skills --skill quality-documentation-manager --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.