Japanese Multinational Biopharmaceutical Company Selects ValGenesis iRisk for Implementing ICH Q14 Framework

SANTA CLARA, Calif., March 12, 2024 /PRNewswire/ — ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), today announced that a Japanese multinational biopharmaceutical company selected ValGenesis iRisk for implementing the ICH Q14 framework on Process Analytical Technology (PAT) analytical methods across its global manufacturing sites.

One of the top 20 largest biopharmaceutical companies in the world, this R&D-driven organization develops and delivers life-changing treatments and transformative therapies to patients around the globe.

Already aware of ValGenesis’ experience helping customers implement PAT tools, the company approached ValGenesis with a requirement to implement a structured framework covering the ICH Q14 guideline on Analytical Method Development, specifically for PAT.

ValGenesis Consulting will lead the implementation of the ICH Q14 framework via a thorough assessment of the customer’s current analytical method development practices across its sites, propose a framework for ICH Q14 adoption using ValGenesis iRisk, build the case for the customer’s product in ValGenesis iRisk, and train a group of key users within their global MSAT team on the utilization of the framework on ValGenesis iRisk with sandbox access. The company was pleased to have the case for one of their products built within the software, which allows them to showcase the solution to more than a dozen global manufacturing sites.

“We are thrilled to onboard yet another biopharma giant through ValGenesis Consulting, which is at the forefront of several successful technology transfers in the industry today,” says Steve Reynolds, Chief Revenue Officer at ValGenesis. “Adopting PAT during commercial production is critical to product safety and quality, enabling large-scale production and process scale-up. With ValGenesis iRisk, our customer is assured of a risk-based Quality by Design (QbD) approach to highly compliant and cost-effective manufacturing.”


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,

SOURCE ValGenesis Inc.