Used to control and manage business processes, enterprise resource planning (ERP) software can be upgraded to ensure compliance with electronic records and signatures (ERES) regulations and guidances as well as other applicable regulations. Cambrex Corporation uses “iRenaissance” (iRen) software manufactured and supplied by Ross Systems, Inc. (www.rossinc.com) at its corporate headquarters in New Jersey and at all European and North American manufacturing facilities. Cambrex developed and initiated validation of its ERP software and customized enhancements in accordance with applicable current US and European regulatory guidances. This project included development of a single, global validation strategy and methodology. Support activities were implemented at all GMP facilities. Fundamental to the validation program was adherence
to a Cambrex global compliance policy document entitled Perspective of 21 CFR Part 11 — Electronic
A MODULAR SYSTEM
The iRen enterprise system is made up of modules that control specific business functions. Each module involved in cGMP compliance had to be validated, so they were identified in a functional design
specification. The GMP criticality of each software module was reviewed to form the basis of a risk
assessment along with supplier audit findings, validation documents, and gap-analysis reports (both for
support infrastructure and the validation documents). The modules identified for inclusion in the
validation project were those used in inventory and quality control, process manufacturing, purchase
order and sales order processing, and systems control.
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