Streamlining Validation for Gene Therapy Commercialization

The customer, an innovator in the research and development of in vivo and ex vivo gene editing therapies, with operations in the U.S. and Switzerland, sought to digitize its validation program to replace cumbersome ‘hybrid’ (a mix of paper-based and digital) validation processes.

Having replaced its hybrid validation processes with Kneat, the customer found that the burden of printing and manual execution was lifted—allowing validation teams to thrive while working remotely, with the ability to access to all documentation and processes and gain full transparency.

Kneat was needed so that we could have scripts, tests, testing executions, all in one system. It was prudent to get the solution now so that we can build on it as we progress towards commercialization. Kneat has helped harmonize validation efforts by having full transparency and eliminating manual testing execution, thereby reducing time and effort.

Customer’s IT Manager, Computer System Validation

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