FDA ERP Validation Checklist & Templates for 21 CFR Part 11
Learn how to validate an ERP system for FDA 21 CFR Part 11 and GxP without bloating scope. This guide shows a risk‑based path through IQ/OQ/PQ, the exact Part 11 controls to prove (e‑signatures, audit trails, timeouts, lockouts), and the evidence auditors expect for backup and restore. Includes concise test snippets you can copy and a downloadable checklist, risk traceability matrix, and test‑case template to accelerate your project. Useful for NetSuite, SAP, and D365 in regu
John Hannan
5 min read