In the life sciences sector, regulatory expectations and operational complexities are constantly evolving. To stay ahead, organizations must continuously reassess their validation processes and digital tools. Doing so ensures compliance, enhances efficiency, and enables global scalability. For a leading CDMO like Catalent, seamless collaboration across multiple sites is critical to maintaining operational efficiency.
When Catalent embarked on a strategic rewrite of its internal computer system validation (CSV) master plan, it was the perfect time to reassess its use of the ValGenesis VLMS platform. Implemented years earlier, the system had already improved Catalent's CSV processes by eliminating paper and manual workflows. However, with a growing global footprint and increasingly complex regulatory requirements, the company recognized the need to enhance the platform's scalability to better support its expanding operations.
A planned system upgrade provided the ideal opportunity to align ValGenesis VLMS with the newly refined CSV master plan and further improve system performance.
Laurie Lipper, IT Computer System Validation Manager, and Jeff Onis, Global IT Data Integrity Manager, led the initiative with the goal of optimizing the platform and ensuring it aligned with the revised validation master plan. This involved incorporating updated standard operating procedures (SOPs), templates, and documents into ValGenesis while facilitating a smooth transition to the upgraded system.
A key focus of this effort was enhancing collaboration. With Catalent’s global workforce, the ability to seamlessly share validation data across teams and sites was essential for maintaining efficiency.
As Catalent worked to enhance its use of ValGenesis VLMS, the team focused on several key areas: ensuring synchronization with the revised validation master plan, scaling the system to support global operations, refining user access controls, improving training, and reinforcing standardization. Each of these efforts played a critical role in strengthening compliance, enhancing efficiency, and driving long-term operational improvements.
Aligning Technology with Evolving Processes
The optimization effort involved more than upgrading technology—it involved ensuring that Catalent’s validation master plan and VLMS worked in sync. The team mapped existing validation workflows to newly refined SOPs, ensuring compliance and consistency across all sites.
Scaling for Global Operations
With its expanding footprint, Catalent needed a system capable of managing validation for multiple global sites and IT systems. The scalability of ValGenesis VLMS allowed the company to consolidate all validation records into a centralized system. Today, more than 25 global IT systems are managed through ValGenesis, ensuring seamless validation workflows and a single source of truth for all records.
“When we rolled out ValGenesis for CSV in 2017, it was tailored to validate a single enterprise resource planning system. As our global operations grew, we faced the challenge of extending the system’s use to additional platforms,” Onis noted. “While we initially built on a model that wasn’t originally designed for multiple systems, the platform’s scalability has enabled us to expand and adapt it to our broader validation needs. Now we manage over 25 global IT systems in ValGenesis.”
Enhancing Role-Based Access and Data Integrity
Catalent identified inefficiencies in existing user role configurations that granted excessive access permissions to some users. To enhance security and enforce better governance, the team:These refinements strengthened data integrity by ensuring that only authorized personnel could access critical validation records. As a result, compliance risks were significantly reduced.
Improving User Training and Change Management
With system changes came the need for enhanced user training. Catalent introduced:This hands-on approach was particularly beneficial for users whose roles and privileges had been adjusted during the reconfiguration.
Reinforcing Standardization for Compliance and Clarity
One of ValGenesis’ key advantages is its ability to enforce standardization. This strengthens compliance and helps reduce the cost of quality. While Catalent had already benefited from this capability, the team identified opportunities to leverage it more effectively. To improve consistency across validation processes, they:By maximizing the standardization features within ValGenesis, Catalent improved compliance, enhanced communication, and streamlined validation workflows across its global operations.
Want to learn more? Read the full case study to explore Catalent’s complete transformation and key takeaways for your organization.