GxP AI Validation Guides & Compliance Frameworks
Practical frameworks and checklists for 21 CFR Part 11 electronic records, GAMP 5 / CSA validation, and GxP-aware third-party vendor security.
The Complete Guide to 21 CFR Part 11 Compliance for AI Systems
A practical framework for implementing AI tools within FDA-regulated environments. Learn how to validate AI systems, maintain audit trails, and ensure compliance with electronic records requirements.
GAMP 5 Meets AI: A Practical Validation Approach
Bridge the gap between traditional GAMP 5 validation and modern AI/ML systems. Includes decision trees, risk assessments, and validation templates adapted for intelligent systems.
GxP-Aware Vendor Cybersecurity Risk Assessment Checklist
A structured 50-point checklist for evaluating vendor cybersecurity posture through a GxP lens. Covers data integrity, access controls, incident response, and supply chain security.
Need Hands-On Validation & Implementation Support?
Our domain and CSV teams deploy AI agents that meet FDA, 21 CFR Part 11, and GAMP 5 requirements from day one.
Book a Demo →