Meet ValGenesis

We’re on a mission

In 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard.

Today, we continue to push the boundaries of innovation ― enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations.

A history of innovative firsts

ValGenesis started for one reason: to bring order to the chaos of traditional validation. At the time, validation involved multiple departments and separate systems, creating islands of data, both digital and paper-based. It was fragmented, messy, and time-consuming. Company founder and industry veteran Dr. Siva Samy, Ph.D., envisioned connecting all validation steps into one fully digital lifecycle process to improve product quality and accelerate product delivery. The industry’s first digital VLMS was born.

FDA’s 2011 process validation guidance emphasized a risk-based approach and continuous monitoring. ValGenesis responded with patented features like dynamic trace matrix creation and impact assessment. We pioneered risk assessment at the requirement level and introduced compliant test case execution.

And we continue to set the pace. ValGenesis VLMS with Design Manager is the first and only validation application built to comply with the FDA’s CSA guidance out of the box.

While we take great pride in our innovative history, we take even greater pride in helping our customers put that innovation to work throughout their organizations.