iC&Q & Tracematrix

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.

Integrated Commissioning & Qualification

With REXS you can implement your iC&Q projects easily and automatically. The FMEA serves as the core of the risk-based approach.

Traceability and Test Matrix

With REXS, the FMEA can be easily extended to a Traceability & Test Matrix. This allows you to define the scope of testing for the subsequent C&Q phases, including the leveraging approach, in a risk-based and comprehensive approach, and also provides you with an overview of your project status at all times.