iC&Q 4.0 with REXS
The aim of the iC&Q concept is to integrate supplier acceptance tests - i.e. commissioning in FAT and SAT - as comprehensively as possible into the qualification of medical device and pharmaceutical manufacturers. On the one hand, this is intended to avoid multiple testing and, on the other, to identify failures in production equipment at an early stage - even before they are delivered to the customer.
With REXS, iC&Q can be implemented simply and efficiently as well as risk-based and automated. The FMEA forms the core of the risk-based iC&Q approach. From the beginning, the FMEA is extended to the traceability matrix and is updated continuously.