Can I customize the document numbering system?

Absolutely. While it provides a standard format (PREFIX-CATEGORY-SEQUENCE), it is designed to help you implement and maintain any specific convention required by your organization.

How does it handle 21 CFR Part 11?

The skill provides detailed guidelines and checklists for electronic record controls, secure audit trails, and signature manifestation required by FDA regulations.

Does this skill help with ISO 13485?

Yes, it provides frameworks and workflows specifically designed for ISO 13485-compliant quality management systems, including document numbering and approval matrices.

What document types are supported?

It includes management patterns for all standard QMS types including Quality Manuals (QM), SOPs, Work Instructions (WI), Templates (TF), Specifications (SPEC), and Plans (PLN).

Does it include tools for validation?

Yes, it includes guidance for document validation scripts that check for numbering compliance, metadata completeness, and 21 CFR Part 11 control integrity.

Quality Documentation Manager

Name: Quality Documentation Manager
Author: micsapp

bymicsapp

0•

Aprendizaje y Documentación

Manages medical device quality management system (QMS) documentation with strict version control and regulatory compliance.

This skill streamlines the management of document control systems for ISO 13485-compliant quality management environments, specializing in medical device regulations. It automates and enforces standards for document numbering, multi-stage approval workflows, and change control processes, ensuring full compliance with FDA 21 CFR Part 11 requirements for electronic records and signatures. It is an essential tool for quality assurance professionals and engineers needing to maintain a rigorous, audit-ready documentation lifecycle from draft to obsolescence.

Características Principales

01Comprehensive document lifecycle and retention tracking

020 GitHub stars

03Multi-stage approval and reviewer matrix management

04Impact assessment checklists for systematic change control

05Automated QMS document numbering and categorization system

0621 CFR Part 11 electronic signature and audit trail guidance

Casos de Uso

01Validating electronic record systems for FDA Part 11 compliance

02Designing an ISO 13485-compliant document control system from scratch

03Managing complex change control workflows for medical device software

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add micsapp/micstec-skills quality-documentation-manager

For use in Claude.ai and ChatGPT

Características Principales

01Comprehensive document lifecycle and retention tracking

020 GitHub stars

03Multi-stage approval and reviewer matrix management

04Impact assessment checklists for systematic change control

05Automated QMS document numbering and categorization system

0621 CFR Part 11 electronic signature and audit trail guidance

Casos de Uso

01Validating electronic record systems for FDA Part 11 compliance

02Designing an ISO 13485-compliant document control system from scratch

03Managing complex change control workflows for medical device software

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add micsapp/micstec-skills quality-documentation-manager

For use in Claude.ai and ChatGPT