What kind of change control processes are included?

It features a comprehensive workflow covering change request initiation, impact analysis, technical validation, and post-change effectiveness monitoring.

How does this skill support ISO 13485 compliance?

It provides a specific framework for Clause 4.2.3, covering document classification, approval workflows, version control, and retention management.

Does it support electronic signatures?

The skill includes an Electronic Signature Framework designed to meet 21 CFR Part 11 requirements for system validation and audit trails.

Can I use this for FDA and EU MDR submissions?

Yes, the skill includes specialized oversight for technical documentation, including 510(k) assembly and Annex II/III compliance for European markets.

Quality Documentation Manager

Name: Quality Documentation Manager
Author: pur3v4d3r

bypur3v4d3r

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콘텐츠 관리

Manages comprehensive document control systems and regulatory compliance reviews for medical device and highly regulated organizations.

소개

The Quality Documentation Manager skill equips Claude to function as a senior-level documentation lead, specializing in the design and implementation of document control systems compliant with ISO 13485 and FDA 21 CFR Part 11. It provides structured frameworks for change management, configuration control, and multi-jurisdictional regulatory review (including EU MDR and FDA 510(k)). This skill is essential for maintaining documentation integrity throughout the product lifecycle, ensuring audit readiness, and automating complex document workflows within a technical codebase or PKB.

주요 기능

1 GitHub stars
Systematic change control and impact assessment workflows
ISO 13485 and 21 CFR Part 11 compliance framework design
Electronic Document Management System (eDMS) implementation strategies
Comprehensive documentation quality metrics and audit-readiness tracking
Multi-jurisdictional regulatory document oversight (EU MDR, FDA, TGA)

사용 사례

Managing complex engineering change orders and synchronized multi-language document updates.
Establishing a document control system for a medical device startup to ensure regulatory compliance.
Performing technical review and validation of documentation for regulatory submission packages.

소개

주요 기능

1 GitHub stars
Systematic change control and impact assessment workflows
ISO 13485 and 21 CFR Part 11 compliance framework design
Electronic Document Management System (eDMS) implementation strategies
Comprehensive documentation quality metrics and audit-readiness tracking
Multi-jurisdictional regulatory document oversight (EU MDR, FDA, TGA)

사용 사례

Managing complex engineering change orders and synchronized multi-language document updates.
Establishing a document control system for a medical device startup to ensure regulatory compliance.
Performing technical review and validation of documentation for regulatory submission packages.