San Francisco, February 11, 2020
ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management Solutions (VLMS), today announced that one of the largest CDMOs in southern Europe has chosen ValGenesis’s 100% paperless VLMS to digitize its corporate validation lifecycle process across multiple sites.
With over half a century’s experience in the development and compliant manufacture of Active Pharmaceutical Ingredients (APIs) and Drug Product Intermediates, the company also provides these services for branded pharmaceutical customers to bring innovative, off-patent drugs and highly potent compounds to market. This CDMO and fully integrated supplier offers drug substance, drug product intermediates and drug product services through development laboratories in southern Europe and the U.S. and through four FDA inspected sites across the U.S., China, Ireland, and southern Europe.
A heavily paper-based approach to validation activities was causing frequent and costly disruptions that made the company’s audit process across sites difficult and inefficient. That’s when it decided to go paperless. After a thorough evaluation of many tools in the market and a proof of concept, the company selected ValGenesis VLMS, a fully compliant electronic validation lifecycle management system. It was impressed by many proven case studies on the ValGenesis VLMS’s ability to significantly reduce validation cycle time while enabling audit-ready processes. The project will commence with equipment validation and the ValGenesis system being expanded across sites in Ireland, U.S. and China. The company also plans to work with ValGenesis to digitize their computer system validation, process validation, and cleaning validation processes.
“There are far too many challenges associated with a paper-driven system, which hampers compliance. Achieving consistency becomes far more difficult than it needs to be in a paper-based manual validation process. We are happy that more and more global companies are convinced by the ValGenesis VLMS - a best-in-class data-driven, digital validation solution that gives them all the control they need with the ability to adhere to global compliance requirements with ease,” says Narayan Raj, Sr. Vice President, Global Sales & Operations, ValGenesis Inc.