Santa Clara, December 5, 2023, ValGenesis, Inc.
ValGenesis, Inc., renowned in validation lifecycle management systems (VLMS), proudly announces its partnership with one of the top 5 global cell and gene therapy manufacturers. The company opted for the ValGenesis digital validation platform to revolutionize its validation processes globally, underscoring its commitment to improving the quality and efficiency of CAR-T therapy production.
Having treated thousands of patients with CAR-T cell therapy, more than any other in this domain, the company sees its collaboration with ValGenesis as a key strategy in reinforcing its commitment to precision and speed in developing CAR-T therapies. This collaboration is aligned with their 'right-first-time' approach, aiming for swift development while ensuring regulatory compliance.
ValGenesis VLMS is the complete digital solution to manage the entire validation lifecycle for this global manufacturer. Transitioning from traditional paper-based methods to a fully digital framework marks a milestone in operational efficiency and traceability.
Steve Reynolds, Chief Revenue Officer at ValGenesis, says, “Our platform's adaptability and highly configurable features allow life science organizations to deploy solutions at single locations and then expand them globally. It enables remote, real-time monitoring of validation activities, promoting consistency and standardization in the validation programs across global sites, which helps reduce costs and cycle time.”
Reynold further notes, “It is an honor to partner with this customer, a trailblazer in cell therapy. Our VLMS is a perfect fit for their commitment to quality and swift market delivery. This alliance exemplifies our resolve to fulfill the sophisticated needs of the cell and gene therapy industry.”
This partnership reinforces our customer’s stature as an innovator in cell therapy and highlights ValGenesis's expertise in delivering top-tier digital validation solutions to industry frontrunners.
ValGenesis, Inc. is the creator of an innovative software platform that is a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005. For more information, visit www.valgenesis.com
Further information
Althea D'Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026 althea.dsylva@valgenesis.com