How do life-sciences companies integrate an ERP system into their process and system landscape in a GMP-compliant way?

An ERP integration in a regulated environment rarely fails because of the software and almost always because of the sequence. Three strands have to fit together: the GMP process design determines which functions, such as batch management, goods receipt and batch release, the ERP maps in the first place. The GAMP 5 categorization derives the risk-based validation scope from that before testing begins. And the data migration transfers master data and open batches into the target system in a traceable way. If you only fix the validation scope once the go-live date is already set, you lose validation as the bottleneck. It then moves into the production-critical path, where every correction is expensive.

This is exactly where we come in. At the outset, the requirements analysis makes visible which functions are GMP-critical and which interfaces to LIMS, MES and eQMS must be validated in their own right, before the authorization concept is in place and data is migrated. Audit trail, access control and electronic signature in line with Annex 11 and 21 CFR Part 11 belong in this early phase, because they are configured and not submitted after the fact. This shifts the effort to the front, where corrections are cheap, instead of into the stabilization phase after go-live, where they hit production.