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. A checklist, risk traceability matrix and test-case template are available on request.
John Hannan
5 min read
ERP Guidance to Help Life Sciences Companies Reduce Recall Risk and Improve Product Quality
Recall readiness is not a single feature. It is the ability to detect an issue, contain it quickly, and prove what happened with an audit ready trail.
John Hannan
4 min read