JVT

Case Study: Validation Process Innovation in Molecular Diagnostics

A leading and pioneering Molecular Diagnostics Company with a reputation for innovation, responded to the increasing regulatory oversight on its industry by performing a 360-degree review of all its GxP testing processes, with the goal to make them best in class.  An early focus was Computer System Validation (CSV).

Based on the vision, this process was re-engineered and in parallel transitioned into a fully electronic system.  The result was a streamlined compliant and efficient end-to-end paperless process.

Click here to read the full case study to learn about their strategies implemented, benefits realized, and more.




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