12 must‑have capabilities in 2026 for a CDMO ERP selection
Based on our life sciences experience supporting outsourced operators, including contract development and manufacturing organizations (CDMO) and contract research organizations (CRO), this guide summarizes the ERP software selection requirements vendors must prove, demo, and document.
John Hannan
6 min read
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