San Francisco, October 27, 2020:

ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management Systems (VLMS), today announced that a global biopharmaceutical company has selected ValGenesis VLMS – the industry’s most trusted electronic validation lifecycle management system, to digitize its corporate validation process. The company discovers and develops novel cell therapies for patients across the globe.

Owning one of the world’s largest internal discovery research engines and an expanding manufacturing network across the globe, the company was keen to move away from a manual, paper-based validation process to embrace a 100% digital approach for validation. The client selected ValGenesis VLMS – a complete, end-to-end, digital validation solution that can enable a single source of truth, thereby ensuring data integrity and adherence to all regulatory requirements.

The company’s new facility is under construction and will use ValGenesis VLMS to help their commissioning and qualification effort. The company states that ValGenesis VLMS’s “available standard features are much more than we have seen – regulatory assessment, risk assessment, resource management for capacity planning, and more, which could greatly increase productivity (efficiency) with our validation and qualification activities.” ValGenesis VLMS will help the client achieve more efficient change control management across their IT Business systems and enable control and flexibility in assigning and managing the various validation activities. The ability to generate trace matrixes prior to execution in order to easily and clearly view any deviations and their impact on testing, appears to be one of the features they are most impressed with to help ensure testing is accurate and complete with optimal transparency and traceability. ValGenesis VLMS will also provide an optimal user experience through multilanguage support and standardization of multiple sites across the globe.

“This rapidly growing company is proactively addressing its growth requirements by automating critical areas, including validation processes. ValGenesis VLMS is just the right digital validation system with its array of online collaboration tools to expediate their most timebound projects. Leveraging a template-driven validation authoring approach that can significantly save time, the company will be able to define and enforce the proper level of validation of their assets through powerful, easy-to-use dashboards. We are pleased to partner with them and eager to continue expanding on the capabilities of our system to meet all their validation lifecycle management needs,” says Narayan Raj, Sr. Vice President of Global Sales & Operations at ValGenesis, Inc.

About ValGenesis

ValGenesis, Inc. is the creator of an innovative software platform that serves as 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

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