What document types are covered by this skill?

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

Can it generate and validate document numbers?

It provides a standardized numbering format (PREFIX-CATEGORY-SEQUENCE) and includes scripts to validate that document identifiers are unique and correctly formatted.

Does this skill help with FDA compliance?

Yes, it specifically addresses 21 CFR Part 11 requirements for electronic records and signatures, helping you build systems that meet FDA documentation standards.

How does it handle the change control process?

It outlines a complete workflow including change requests, impact assessments, classification (Minor vs. Major), and automated change history tracking.

Quality Documentation Manager

Name: Quality Documentation Manager
Author: borghei

byborghei

•

コンテンツ管理

Manages medical device QMS document control systems, ensuring ISO 13485 and 21 CFR Part 11 compliance.

The Quality Documentation Manager skill provides a robust framework for designing and maintaining document control systems within highly regulated environments, specifically for medical device manufacturing. It guides users through implementing standardized document numbering conventions, multi-stage approval workflows, and rigorous change control processes. By incorporating 21 CFR Part 11 requirements for electronic records and signatures, it helps quality assurance teams and engineers maintain audit-ready documentation and ensure that all SOPs, work instructions, and forms adhere to strict regulatory standards.

主な機能

01Comprehensive 21 CFR Part 11 electronic signature and audit trail guidance

02ISO 13485-compliant document numbering and versioning logic

0350 GitHub stars

04Structured change control workflows with impact assessment checklists

05Automated validation scripts for QMS document metadata and history

06Full document lifecycle management from draft to obsolescence

ユースケース

01Automating the generation and validation of QMS document headers and change histories

02Conducting gap analyses for 21 CFR Part 11 electronic record compliance

03Establishing a compliant Document Control System for a medical device startup

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add borghei/claude-skills quality-documentation-manager

For use in Claude.ai and ChatGPT

Download Skill