Fujirebio Diagnostics, Inc. uses Kneat to provide CSV at scale

Fujirebio Diagnostics, Inc. (FDI)
Computer System Validation (CSV)

In-vitro diagnostics industry leader Fujirebio Diagnostics, Inc. (FDI), selected Kneat to digitize its global Computer System Validation (CSV) process with the aim of enabling its limited IT Compliance Team to deliver a large volume of complex computer-system projects, including the implementation and re-validation of systems at multiple manufacturing sites across five divisions.

As a result of this digital validation initiative, FDI achieved a 53% reduction in time for quality management (CAPA) system change control projects, reduced the number of working days for script execution from 15 to just seven on average, and eliminated reliance on a time-consuming ‘hybrid’ validation system, driving efficiencies for the validation team.

Cycle-Time Reduction for Change Control
Fewer Hours for Script Execution
Remote Validation

It’s what I really wanted, the ability to still author and execute in the traditional manner, but not having the ‘on paper’ anymore. With Kneat, we can write like we’ve always written, following the same standards for test script authoring, use of formatting, language…but without paper…and the worry of making a mistake, a smudge, or writing the wrong value, or date.

- Kathianne Ross, Manager IT Compliance, Fujirebio Diagnostics

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