ValGenesis Unveils VLMS 5.0, Revolutionizing Digital Validation with Industry-First AI Innovation

Santa Clara, June 6, 2024. ValGenesis Inc., the market leader in digital validation software solutions for life sciences, today announced the launch of VLMS 5.0, the revolutionary new version of its flagship digital validation lifecycle management software poised to transform the industry's approach to digital transformation.

VLMS 5.0 introduces a new era of industry-first AI capabilities that provide intelligent insights across validation activities to unlock unprecedented operational efficiency. In addition, its unique risk-based approach promotes critical thinking, automates assurance activities, and fosters deeper regulatory alignment.

"Life sciences leaders are demanding modern, AI-powered platforms to strengthen their digital roadmaps and achieve their Pharma 4.0 vision," said Dr. Siva Samy, CEO of ValGenesis. "VLMS 5.0 is that game-changing solution, fusing unrivaled functionality, an exceptional user experience, and pioneering AI innovation."

The platform features a holistically redesigned user interface that prioritizes simplicity, usability, and data integrity. Workflows expedite task completion, dynamic data visualizations ensure clarity into validation activities across the enterprise, and enhanced analytics tools enable users to make objective, data-driven decisions.

As new regulatory standards like the FDA's Computer Software Assurance (CSA) emerge, VLMS 5.0 equips companies to meet these demands out of the box. The platform natively supports risk-based testing, automated and unscripted testing methodologies, and the assurance activities required for rigorous regulatory compliance. Furthermore, its robust analytics capabilities ensure real-time status and audit readiness, simplifying compliance management.

"The life sciences industry is undergoing a seismic shift, and maintaining the status quo is no longer an option," said Kevin Shaw, Vice President of Product Management at ValGenesis. "VLMS 5.0 propels companies into the future with an AI-powered smart validation platform that meets the industrial demands of life sciences manufacturing while providing entirely new opportunities for data-driven decision-making. It changes the game."

With a proven track record of serving 30 of the top 50 life sciences companies globally, ValGenesis VLMS solidifies its position as the industry standard for digitizing validation lifecycles across CSA, commissioning and qualification, cleaning, analytical method, and process validation. 

"VLMS 5.0 continues ValGenesis' legacy of relentless innovation to solve the toughest challenges facing our customers," concluded Dr. Samy. "We are proud to deliver this pioneering technology that will not only meet but exceed the evolving needs of the life sciences industry."


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

Further Information

Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026,