Quality Documentation Manager — Documentation

This skill manages document control systems for medical device quality management systems (QMS), covering document numbering, version control, change management, approval workflows, and 21 CFR Part 11 compliance. It provides structured procedures, templates, and validation tools to ensure regulatory compliance and effective document lifecycle management.

ra-qm claude-code

📂 View skill on GitHub ↗ 🚀 How to use

✨ What it does

Defines document numbering format and category codes.
Outlines approval and review workflows with required reviewers and approvers.
Provides change control classification and impact assessment checklist.
Details 21 CFR Part 11 electronic record and signature requirements.
Includes a document validator script for automated checks.
Tracks document control metrics and periodic review schedules.

🎯 When to use it

When designing or updating document control procedures for a medical device QMS.
When assigning document numbers or managing version control for controlled documents.
When implementing or reviewing change control workflows for document revisions.
When ensuring electronic records and signatures comply with 21 CFR Part 11.
When conducting audits or reviews of document control processes.

🚀 How to use

Trigger by asking for help with document control, document numbering, version control, change control, approval workflows, electronic signatures, or 21 CFR Part 11 compliance. Provide details such as document type, current revision, or specific compliance questions. Use the provided procedures and tools to guide your actions.

Example prompts:

How should I number a new SOP for document control?
What are the approval requirements for a work instruction?
How do I ensure my electronic signature system complies with 21 CFR Part 11?

📄 Output: Guidance, procedures, and validation tools for managing controlled documents in a medical device QMS.

📦 Add this skill to Claude Code

# 1. Get the skills repo
git clone --depth 1 https://github.com/alirezarezvani/claude-skills /tmp/claude-skills

# 2. Copy this skill into your project (or ~/.claude/skills for all projects)
mkdir -p .claude/skills
cp -r /tmp/claude-skills/ra-qm-team/skills/quality-documentation-manager .claude/skills/quality-documentation-manager

Skill source: ra-qm-team/skills/quality-documentation-manager/SKILL.md

⚠️ Good to know

This skill provides guidance based on ISO 13485 and 21 CFR Part 11; it does not replace legal or regulatory advice and assumes the user has a basic understanding of QMS concepts.

❓ FAQ

What is the standard document numbering format?

The standard format is PREFIX-CATEGORY-SEQUENCE[-REVISION], e.g., SOP-02-001-A, where prefix indicates document type, category is a functional area code, sequence is a sequential number, and revision is a letter or number.

What are the required reviewers for an SOP?

For an SOP, required reviewers are Process Owner and QA, and required approvers are QA Manager and Process Owner.

What are the electronic signature requirements under 21 CFR Part 11?

Electronic signatures must be unique to each individual, have at least two components (e.g., user ID and password), display a manifestation (name, date/time, meaning), and be linked to the record so they cannot be excised or copied.

🤖 Overview, features, install steps and FAQ were generated from the project's SKILL.md on Sep 4, 2026. Always check the original source before running commands.