Leading Global Biotechnology Company Selects ValGenesis iRisk

Santa Clara, April 16, 2024, ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), today announced that a leading global biotechnology company selected ValGenesis iRisk to digitalize the quality risk management processes across its manufacturing sites.

A pioneer in scientific research for complex and devastating diseases, the company is advancing a pipeline of potential critical drug therapies across neurology, neuropsychiatry, specialized immunology, and rare diseases.

Hearing about iRisk from a ValGenesis customer, the company approached ValGenesis to implement iRisk at its headquarters in the United States, to support its small molecule drug product development team in the digitalization of its quality risk management processes.

ValGenesis iRisk is the best platform in the market to manage quality by design (QbD) processes in pharmaceutical development, converging all risk-related actions into a unified workflow. This empowers life sciences companies to optimize their pharmaceutical development processes with significant gains in process efficiency, data and knowledge management, and general process quality. Best-in-class pharmaceutical companies, including multiple top 10 global enterprises, use ValGenesis iRisk to optimize the efficiency of their pharmaceutical development processes and QbD frameworks by applying iRisk's unique capabilities.

“Having the best risk management tools gathered collectively under ValGenesis iRisk is a game changer for customers. iRisk helps them achieve higher levels of efficiency and compliance, and helps them identify potential problems and vulnerabilities in their business decisions even before they escalate,” says Steve Reynolds, Chief Revenue Officer at ValGenesis. “We continue to redefine risk management benchmarks and are excited to empower this customer in their advancement of critical drug pipelines.”


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 https://www.valgenesis.com/

Further Information

Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026, althea.dsylva@valgenesis.com