Content Preview
# 21 CFR Part 11 Compliance Guide Electronic records and electronic signatures compliance for FDA-regulated systems. --- ## Table of Contents - [Part 11 Overview](#part-11-overview) - [Electronic Record Requirements](#electronic-record-requirements) - [Electronic Signature Requirements](#electronic-signature-requirements) - [System Controls](#system-controls) - [Validation Requirements](#validation-requirements) - [Compliance Checklist](#compliance-checklist) --- ## Part 11 Overview ### S
How to Use
Recommended: Install to project (local)
mkdir -p .claude/skills
curl -o .claude/skills/21cfr11-compliance-guide.md \
https://raw.githubusercontent.com/alirezarezvani/claude-skills/main/ra-qm-team/quality-documentation-manager/references/21cfr11-compliance-guide.mdSkill is scoped to this project only. Add .claude/skills/ to your .gitignoreif you don't want to commit it.
Alternative: Clone full repo
git clone https://github.com/alirezarezvani/claude-skillsThen reference at ra-qm-team/quality-documentation-manager/references/21cfr11-compliance-guide.md
Related Skills
cs-quality-regulatory
Quality & Regulatory agent for ISO 13485 QMS, MDR compliance, FDA submissions, GDPR/DSGVO, and ISMS audits. Orchestrates ra-qm-team skills. Spawn when users need regulatory strategy, audit preparation, CAPA management, risk management, or compliance documentation.
agentsqualityregulatoryagent
by alirezarezvani · alirezarezvani-claude-skills
CLAUDE
Regulatory Affairs & Quality Management Skills - Claude Code Guidance
ra-qm-teamclaude
by alirezarezvani · alirezarezvani-claude-skills
SKILL
12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).
ra-qm-teamskillagentpython
by alirezarezvani · alirezarezvani-claude-skills
effectiveness-verification-guide
Effectiveness Verification Guide
ra-qm-teameffectivenessverificationguide
by alirezarezvani · alirezarezvani-claude-skills