ValGenesis, Inc., an Enterprise Validation Lifecycle Management Solutions (VLMS) provider, has been selected by a large CDMO in southern Europe for its 100% paperless VLMS to digitize its corporate validation lifecycle process across multiple sites. 

The CDMO develops and manufactures APIs and Drug Product Intermediates through development labs 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. The company selected ValGenesis VLMS, a fully compliant electronic validation lifecycle management system. The VLMS aims 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,” said Narayan Raj, senior vice president, Global Sales & Operations, ValGenesis Inc.