21-cfr-part-11
CommunityExpert guidance for FDA 21 CFR Part 11 compliance in healthcare software.
Authoraks-builds
Version1.0.0
Installs0
System Documentation
What problem does it solve?
This Skill provides expert guidance on implementing and validating FDA 21 CFR Part 11 compliance for electronic records and signatures in healthcare software, ensuring regulatory adherence and data integrity.
Core Features & Use Cases
- Expert Compliance Guidance: Delivers detailed explanations of Part 11 regulations and best practices.
- Risk-Based Assessment: Assesses whether a system is in scope of Part 11 and determines appropriate compliance measures.
- Use Case: A clinical trial EDC system needs to ensure compliance with Part 11. This Skill guides the assessment, identifying relevant predicate rules and outlining necessary controls.
Quick Start
Use the 21-cfr-part-11 skill to assess the compliance of your clinical trial EDC system with FDA 21 CFR Part 11.
Dependency Matrix
Required Modules
None requiredComponents
scriptsreferences
💻 Claude Code Installation
Recommended: Let Claude install automatically. Simply copy and paste the text below to Claude Code.
Please help me install this Skill: Name: 21-cfr-part-11 Download link: https://github.com/aks-builds/healthcareskills/archive/main.zip#21-cfr-part-11 Please download this .zip file, extract it, and install it in the .claude/skills/ directory.
Agent Skills Search Helper
Install a tiny helper to your Agent, search and equip skill from 620,000+ vetted skills library on demand.