Catalent's Journey Of Continuous Improvement For CSV Excellence

By Lisa Weeks, Marketing Director, ValGenesis

In the ever-evolving life sciences sector, regulatory expectations and operational complexities are perpetually changing. To stay ahead of these shifts, organizations must continuously reassess their validation processes and digital tools. This ongoing evaluation ensures compliance with regulatory standards, enhances operational efficiency, and enables global scalability. For a leading Contract Development and Manufacturing Organization (CDMO) like Catalent, seamless collaboration across multiple sites is crucial for maintaining operational efficiency.

Catalent's strategic decision to overhaul its internal Computer System Validation (CSV) master plan provided an ideal opportunity to reassess its use of the ValGenesis Validation Lifecycle Management System (VLMS) platform. Initially implemented several years ago, the ValGenesis VLMS had already significantly improved Catalent's CSV processes by eliminating paper-based and manual workflows. However, with Catalent's expanding global presence and increasingly complex regulatory demands, the company recognized the necessity to enhance the platform's scalability.

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