What you'll get
This skill helps you set up and manage a document control system for medical device companies that need FDA compliance. It covers how to number documents, route them for approval, track changes, and maintain electronic records that meet regulatory requirements. Quality managers, regulatory affairs teams, and operations leaders use this to keep their documentation organized and audit-ready.
Step 1 — Get the skill source URL
The Quality Documentation Manager skill lives at:
Step 2 — Add it to your AI agent
Copy one of these prompts and paste it into your AI tool. The agent will fetch and install the skill for you.
Claude Code
Add the agent skill from https://clawhub.ai/alirezarezvani/quality-documentation-manager to my project.
Cursor
Install this agent skill: https://clawhub.ai/alirezarezvani/quality-documentation-manager
Codex
Add this skill to .codex/skills/: https://clawhub.ai/alirezarezvani/quality-documentation-manager
Gemini CLI
Add the skill at https://clawhub.ai/alirezarezvani/quality-documentation-manager to my .gemini/skills/ directory.
OpenCode
Install this agent skill from https://clawhub.ai/alirezarezvani/quality-documentation-manager
Windsurf
Add this skill: https://clawhub.ai/alirezarezvani/quality-documentation-manager
Step 3 — Try these prompts
Once the skill is installed, ask your AI things like:
- Setting up a quality management system for a medical device company
- Organize documentation for an FDA audit or ISO 13485 certification
- Implementing electronic document control to replace paper-based systems
- Establish change control procedures for regulated documents
What this skill does
- Creates document numbering systems with category codes and revision tracking
- Designs approval workflows that route documents to the right reviewers based on type
- Sets up change control processes that classify updates and assess their impact
- Implements electronic signature and record controls that meet 21 CFR Part 11 requirements
- Maintains document master lists and lifecycle tracking from draft to obsolete