Quality Documentation Manager
Skill Verified ActiveDocument control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.
To streamline and ensure compliance of document control processes within medical device QMS, supporting regulatory adherence and operational efficiency.
Features
- Document numbering system validation
- Lifecycle stage tracking (Draft to Obsolete)
- Review and approval workflow management
- Change control process guidance
- 21 CFR Part 11 compliance checks for records and signatures
- Validation tool for document metadata
Use Cases
- Ensuring compliance with ISO 13485 and FDA regulations
- Implementing standardized document numbering and versioning
- Managing document review, approval, and change control workflows
- Auditing and validating electronic records and signatures for 21 CFR Part 11
- Establishing clear document lifecycle stages and retention policies
Non-Goals
- Replacing a full Document Management System (DMS) software
- Providing legal advice on regulatory interpretation
- Managing non-document-related QMS processes (e.g., CAPA implementation)
- Handling general content creation outside of QMS documentation structure
Practices
- Document Control Procedures
- Regulatory Compliance
- Quality Management Systems
- 21 CFR Part 11
- Auditing
Prerequisites
- Python 3 interpreter (for the validation script)
Documentation
- info:READMEThe README.md is extensive and lists many skills, but does not specifically detail the 'quality-documentation-manager' skill beyond its inclusion in the 'ra-qm-skills' category.
Installation
First, add the marketplace
/plugin marketplace add alirezarezvani/claude-skills/plugin install ra-qm-team@claude-code-skillsQuality Score
VerifiedTrust Signals
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