ERP selection and validation in FDA‑regulated companies (CSV & 21 CFR Part 11)
Most teams treat validation after vendor choice—backwards. This guide shows how to bake CSV and 21 CFR Part 11 into ERP selection: translate URS into measurable criteria, compare vendors on audit trails, e‑signatures, and role security, and outline a pragmatic VMP with risk‑based IQ/OQ/PQ. The goal is selection that stands up in audit and in operations—no bolt‑on validation scramble later.
John Hannan
4 min read
FDA ERP Validation (21 CFR Part 11): Practical Checklist & Templates
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