Case Study: Fujirebio Diagnostics achieves faster, paperless CSV with Kneat Solutions

Fujirebio Diagnostics, Inc uses Kneat to provide CSV at scale

Fujirebio Diagnostics, Inc. (FDI), a leader in the in-vitro diagnostics industry, faced the challenge of managing a rapidly growing volume of computer system validation (CSV) projects with a small IT compliance team. Their manual, paper-based process was laborious and inefficient, requiring testers to print, hand-write, and physically archive all documentation. Seeking a 21 CFR Part 11 compliant digital solution to increase efficiency and enable remote work, they selected the Kneat platform to digitize their global CSV process.

By implementing Kneat's digital validation solution, Fujirebio Diagnostics eliminated its paper-based system and enabled 100% remote test execution. The results were significant, including a 53% reduction in time for quality management change control projects and a 40% reduction in labor hours for script execution. Kneat provided full transparency and audit-readiness, allowing FDI's lean team to efficiently manage a large number of complex global projects.

Fujirebio Diagnostics, Inc.

Kathianne Ross

Manager IT Compliance