quality-documentation-manager

Manage document control workflows for medical device QMS compliance.

Updated Feb 16, 2026

Search Tags:#regulatory compliance #medical device #qms #iso 13485 #document control #21 cfr part 11

Ready to run

npx skills add https://github.com/Nuwanda04/Ballen-Fisk --skill quality-documentation-manager-nuwanda04

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: quality-documentation-manager
Source: https://github.com/Nuwanda04/Ballen-Fisk/tree/main/.cursor/skills/quality-documentation-manager
Command: npx skills add https://github.com/Nuwanda04/Ballen-Fisk --skill quality-documentation-manager-nuwanda04

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill requires pypdf, pdfplumber, pdf2image, and includes scripts (resource) and references (resource) components.

What problem does it solve?

This Skill streamlines the management of quality documentation within a medical device Quality Management System (QMS), ensuring compliance with standards like ISO 13485 and regulations such as 21 CFR Part 11.

Core Features & Use Cases

Document Control: Manages the entire lifecycle of controlled documents, from creation to obsolescence.
Regulatory Compliance: Ensures adherence to critical regulations like 21 CFR Part 11 for electronic records and signatures.
Use Case: A quality manager needs to ensure all Standard Operating Procedures (SOPs) are correctly numbered, reviewed, approved, and stored according to regulatory requirements. This Skill provides the framework and tools to achieve this efficiently.

Quick Start

Use the quality-documentation-manager skill to validate the document numbering convention for the provided document details.

Frequently Asked Questions about quality-documentation-manager

High-intent search queries and answers about installing and using this skill.

FAQPage Schema

How do I manage document control for a medical device QMS?▼

Medical device QMS document control is managed by tracking document numbering, version control, change management workflows, and regulatory compliance. This Skill automates validation using Python scripts to ensure SOPs and controlled documents meet ISO 13485 lifecycle requirements.

What is 21 CFR Part 11 compliance for electronic records?▼

21 CFR Part 11 compliance for electronic records requires implementing secure electronic signatures and validation controls. This Skill provides reference documents and validation scripts to ensure your QMS documentation adheres to these FDA electronic signature regulations.

How to validate document numbering conventions for ISO 13485 SOPs?▼

Validating document numbering conventions for ISO 13485 SOPs involves checking assigned document details against predefined formatting rules. This Skill utilizes Python scripts to automatically verify that your controlled documents follow the correct numbering structure.

Does this QMS documentation manager support change control workflows?▼

Yes, this QMS documentation manager supports change control workflows by providing structured procedures for document lifecycle management. It covers creation, review, approval, and obsolescence phases to maintain regulatory compliance during document revisions.

Can I use Python to validate PDF documents for regulatory compliance?▼

Yes, you can use Python to validate PDF documents for regulatory compliance by utilizing libraries like pypdf, pdfplumber, and pdf2image. This Skill integrates these dependencies to extract and process document data for QMS compliance validation.

When do I need 21 CFR Part 11 compliance for my quality management system?▼

You need 21 CFR Part 11 compliance for your quality management system when maintaining electronic records or using electronic signatures for regulatory documentation. This Skill provides the necessary compliance framework and reference procedures for FDA-regulated medical devices.