Fujirebio Diagnostics, Inc uses Kneat to provide CSV at scale

Fujirebio Diagnostics faced a Computer System Validation (CSV) workload growing to 30-40 systems a year and needed a scalable way to keep up while preserving data integrity. It implemented Kneat, the only solution it found meeting its requirements, valued for letting staff 'still author and execute in the traditional manner, but not having the 'on paper' anymore,' per a Fujirebio manager. Results: 53% faster change-control processing for CAPA (Corrective and Preventive Action) and a 40% reduction in hours needed for test-script execution, translating into meaningful cost savings.

Kneat is a paperless computer-system and process-validation platform — one of the two dominant players in digitizing the validation evidence GxP systems require before go-live.

This sits in the Ship stage of the AI use-case lifecycle: Named examples from the vendors pharma teams use to get an AI system live inside a real, regulated production workflow — validation, CRM, safety and clinical systems of record.