Individual skill
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.
ra-qm-team/skills/quality-documentation-manager/SKILL.md
Source commit 8f082544116fc0d014188e521ca40304cdfc86b0
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- Last checked
- Nov 10, 2026
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- Repository last updated
- Nov 5, 2026
- License
- MIT
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- agentic-ai Repository topic
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SKILL.mdcore · 15,490 bytesSKILL.mdcore · 15,490 bytesreferences/21cfr11-compliance-guide.mddoc · 13,450 bytesreferences/document-control-procedures.mddoc · 12,905 bytesscripts/document_validator.pyruns · 22,838 bytesscripts/document_version_control.pyruns · 17,024 bytes
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# 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.
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## 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)