Catalent's Journey of Continuous Improvement for CSV Excellence

Catalent, a Contract Development and Manufacturing Organization (CDMO) serving pharma and biotech, optimized its use of ValGenesis to enhance global collaboration and validation efficiency. The company upgraded its implementation to improve scalability and compliance across 25+ global IT systems while supporting 400+ users worldwide. The strategic enhancement resulted in accelerated validation cycles, strengthened audit readiness, and real-time collaboration capabilities through daily use of ValGenesis for Computer System Validation (CSV) activities.

ValGenesis is a digital validation-lifecycle platform — one of the two dominant players, alongside Kneat, in producing the validation evidence a GxP system needs before it can 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.