Fujirebio Diagnostics, Inc. Uses Kneat To Provide CSV At Scale

Fujirebio Diagnostics, Inc. (FDI), a recognized leader in the in-vitro diagnostics industry, has chosen Kneat to digitize its global Computer System Validation (CSV) process. This strategic move was driven by the need to empower FDI’s lean IT Compliance Team to manage a high volume of complex computer-system projects efficiently. These projects include both the implementation and re-validation of systems across multiple manufacturing sites, spanning five distinct divisions. The results of this digital transformation have been significant. FDI reported a 53% reduction in the time required to complete quality management system change control projects, specifically those related to Corrective and Preventive Actions (CAPA). Additionally, the average number of working days needed for script execution was cut by more than half—from 15 days down to just seven. Perhaps most notably, the company was able to eliminate its reliance on a cumbersome hybrid validation system, which had previously slowed down processes and consumed valuable resources.

Explore how this shift to a fully digital approach has driven substantial efficiencies for the validation team to enable faster, more consistent, and more compliant project delivery across the organization.