Process Quality Control Software

Source: Werum IT Solutions America, Inc.


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.

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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.

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Werum IT Solutions America, Inc.