quality-documentation-manager
Use for QMS document control: numbering, versioning, change control or 21 CFR Part 11 e-signatures. Validates documents with document_validator.py and tracks versions with document_version_control.py.
Target: Office & team collaboration. Automatically collected · unverified.
Excerpt from the author’s documentation
Extracted from a fixed version of SKILL.md in its original language. This is the author’s documentation; installation, compatibility and runtime results have not been verified by this site.
Read the original English text
Topics in the source
- Quality Documentation Manager
- Table of Contents
- Document Control Workflow
- Document Lifecycle Stages
- Document Types and Prefixes
- Required Reviewers by Document Type
- Document Numbering System
- Numbering Format
Document control system design and management for ISO 13485-compliant quality management systems, including numbering conventions, approval workflows, change control, and electronic record compliance. -- Document Control Workflow Document Numbering System Approval and Review Process Change Control Process 21 CFR Part 11 Compliance Reference Documentation Tools -- 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 | Stage | Definition | Actions Required | |-------|------------|------------------| | Draft | Under creation or revision | Author editing, not for use | | Review | Circulated for review | Reviewers provide feedback | | Approved | All signatures obtained | Ready for training/distribution | | Effective | Training complete, released | Available for use | | Superseded | Replaced by newer revision
This is an excerpt. Refer to the complete source and its current requirements.
- Source repository
- alirezarezvani/claude-skills
- Source file
- ra-qm-team/skills/quality-documentation-manager/SKILL.md
- Fixed revision
- 8f082544116fc0d014188e521ca40304cdfc86b0
Sources and evidence
This record was collected automatically. Its documentation, suitability and runtime behavior have not been manually verified.
Author: alirezarezvani/claude-skills · original repository metadata. Documentation review: Not reviewed. Last source check: 2026-11-09T14:01:47.511Z.
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