PAS-X Process Quality Control captures events and deviations enabling companies to drastically reduce batch review and release time and to implement Review by Exception. It ensures a continuous monitoring of the production quality. In order to achieve the highest possible quality and to take preventative and flexible measures, PAS-X Process Quality Control supports process-analytical on-line, in-line, and at-line quality controls. The function supports the implementations of Process Analytical Technology (PAT) and state-of-the-art Quality by Design (QbD) concepts.
The past years have seen rapid growth in the number of cell therapy products in late stages of clinical trials. However, moving closer to market-approval brings significant operational challenges for companies as their patient populations grow. Electronic systems are emerging as the only option for managing large patient volumes. Werum’s PAS-X MES is ideally suited to target the key challenges for Cell & Gene therapy manufacturers.