How does it ensure 21 CFR Part 11 compliance?

It provides guidelines and automated validation tools for electronic records, audit trails, and signature manifestations required by FDA regulations for electronic documentation.

Can I use this for non-medical documentation?

While optimized for medical device QMS, the structured numbering, version control, and change management workflows are applicable to any highly regulated industry requiring rigorous document integrity.

How do I validate my document metadata?

The skill includes a Document Validator tool that can be run via CLI to check numbering convention compliance, status requirements, and 21 CFR Part 11 control integrity.

What document types does it support?

It includes specific templates and numbering codes for Quality Manuals (QM), Standard Operating Procedures (SOP), Work Instructions (WI), Templates/Forms (TF), and Specifications (SPEC).

Does this skill handle ISO 13485 requirements?

Yes, it is specifically designed to manage document control workflows that meet ISO 13485 standards for medical device quality management systems, covering everything from numbering to record retention.

Quality Documentation Manager

Name: Quality Documentation Manager
Author: alirezarezvani

byalirezarezvani

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9,958

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콘텐츠 관리

Manages document control systems and compliance workflows for medical device quality management systems (QMS).

The Quality Documentation Manager skill equips Claude with specialized knowledge for designing and maintaining ISO 13485-compliant document control systems. It provides structured frameworks for document numbering, approval workflows, and rigorous change control processes while ensuring strict adherence to 21 CFR Part 11 requirements for electronic records and signatures. This skill is essential for medical device manufacturers and highly regulated engineering teams needing to automate documentation validation, manage document lifecycles from draft to obsolescence, and maintain audit-ready records.

주요 기능

01Automated document numbering and category assignment per ISO 13485 standards.

02Standardized document lifecycle management from draft to obsolescence.

039,958 GitHub stars

04Implementation of 21 CFR Part 11 compliant electronic signature and record controls.

05Structured change control workflows with impact assessment and classification.

06CLI-based document validation for metadata, change history, and approval tracking.

사용 사례

01Establishing a compliant document numbering and versioning system for a new medical device project.

02Conducting impact assessments and generating change requests for existing quality procedures.

03Validating documentation metadata and electronic signature manifestations for regulatory audits.

주요 기능

01Automated document numbering and category assignment per ISO 13485 standards.

02Standardized document lifecycle management from draft to obsolescence.

039,958 GitHub stars

04Implementation of 21 CFR Part 11 compliant electronic signature and record controls.

05Structured change control workflows with impact assessment and classification.

06CLI-based document validation for metadata, change history, and approval tracking.

사용 사례

01Establishing a compliant document numbering and versioning system for a new medical device project.

02Conducting impact assessments and generating change requests for existing quality procedures.

03Validating documentation metadata and electronic signature manifestations for regulatory audits.