ValGenesis helps life sciences companies create exceptional products that transform lives.
ValGenesis empowers life sciences companies to improve quality of life by accelerating the delivery of consistent, safe products.
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.
Explore Our Products
Deploy 100% paperless, risk-based validation in CSV and CSA, CQV, equipment validation, and more — with unparalleled power, capability, and flexibility.
Unify all risk-related activities to identify, quantify, and prioritize risks across the product lifecycle in one digital platform.
Digitize and automate the end-to-end cleaning validation lifecycle, from design to qualification to continued monitoring.
Eliminate error-prone, paper-based logbooks for any GMP log type with fully compliant next-generation digitalized logbooks.
Aggregate your process or product history to effectively perform process mapping, digital continued process verification, and process lifecycle management — all in one application.
5201 Great America Parkway, Suite 354
Santa Clara, California 95054
Main Number +1 (510) 445‑0505
Toll-free Number +1 (888) 825‑4363
Fax Number +1 (510) 991‑9901
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