Santa Clara, June 27, 2023: ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), today announced that a global biotechnology company selected ValGenesis VLMS to digitize the computer system validation (CSV) and equipment qualification processes across the organization after a rigorous audit of possible solutions.
The company develops revolutionary therapies with real impact to improve and extend the lives of people living with cancer. It discovers, develops, manufactures, and commercializes cancer therapeutics with antibody-drug conjugates.
Already a ValGenesis iRisk customer expanding rapidly post FDA approval of its latest range of products, the company selected ValGenesis VLMS to digitally transform its upcoming biomanufacturing facility. In the first phase of deployment, ValGenesis will drive their CSV and equipment qualification initiatives.
ValGenesis is the market leader in enterprise validation lifecycle management systems, helping the world’s leading life sciences companies enable compliance and enforce standardization with 100% digital, risk-based validation software. This approach enables companies to sustain a completely paperless approach to validation execution.
“We are excited to support this biotechnology trailblazer in their critical mission of saving lives,” says Steve Reynolds, Chief Revenue Officer at ValGenesis. “Paper-based validation has cost biotech companies heavily in terms of human error driven inefficiencies. Digitizing validation will help them avoid costly manufacturing and regulatory delays that jeopardize patient health while positively impacting their bottom line. We are happy that companies are increasingly turning toward ValGenesis VLMS as the de-facto standard and experiencing the power of digital validation at its best.”
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.
Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026 firstname.lastname@example.org