SANTA CLARA, Calif.–(BUSINESS WIRE)–#DigitalValidation–ValGenesis Inc., the global leader in digital validation and process lifecycle management, has designated Validator K.K. as an Excellence Partner in Japan. Validator K.K. is responsible for implementing ValGenesis solutions to support life sciences organizations across Japan, providing regulatory-compliant validation and digital enablement services to pharmaceutical and biotechnology companies. This collaboration will help Japanese life sciences companies accelerate compliance, improve operational efficiency, and advance digital validation practices.
Under the partnership, Validator K.K. will resell ValGenesis’ Validation Lifecycle Suite (VLS), comprising iVal, iClean, and iOps, and serve as a referral partner for ValGenesis’ Process Lifecycle Suite (PLS), comprising iCMC and iCPV. Validator K.K. will also leverage the ValGenesis platform to serve smaller vendors in Japan, helping extend digital validation capabilities to emerging and mid-sized organizations.
“Japan remains an important market for digital transformation in life sciences,” said Michael Naimoli, vice president of channel partner strategy at ValGenesis. “Validator K.K.’s expertise in commissioning, qualification and validation, and computer system validation, along with a commitment to its values and quality standards, helps ensure customers receive high-quality implementation and ongoing support aligned with local regulatory requirements.”
According to Validator K.K.’s President, Hiroki Tamura, “Japanese pharmaceutical companies are currently facing multiple challenges, including labor shortages, stricter regulations, and a weak yen. Solving these challenges with a single tool or by having only one company in the supply chain to implement digitalization will have limited effectiveness. ValGenesis’ VLS and PLS provide appropriate platforms for each stage of a pharmaceutical company’s development. We are also honored to now be able to offer a package that allows small vendors to utilize the same platform. Going forward, we will continue to support the digitalization of pharmaceutical companies and strive to contribute to the realization of Pharma 4.0.”
The partnership reflects ValGenesis’ strategy to strengthen its presence in key global markets through specialized excellence partners.
About Validator K.K.
Validator K.K. is a Japan-based validation services provider supporting pharmaceutical companies, biotechnology firms and research organizations with regulatory-compliant validation solutions, consulting and digital enablement initiatives. Established in 2015 and headquartered in Osaka, Validator K.K. offers commissioning, qualification and validation (CQV), computer system validation (CSV) and consulting services to help clients strengthen quality systems and meet global regulatory requirements. The company also develops and implements validation tools and supports organizations in digitizing and optimizing validation workflows. Learn more at https://validator.co.jp/en/.
About ValGenesis Inc.
ValGenesis Inc. is the global leader in enterprise digital validation. Serving the life sciences industry for nearly two decades, ValGenesis enables companies to digitize their commissioning, qualification, and validation processes through its AI-enabled ValGenesis Smart GxP™ platform, which includes solutions for risk management, cleaning validation, continued process verification, and CMC development. ValGenesis helps customers worldwide reduce costs, improve compliance, and accelerate innovation. For more information, visit www.valgenesis.com.
Contacts
Further information
Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026, [email protected]
Nguyen Thi Thanh Van, Validator K.K. IT Solutions Division, +81 80-1116-0640, [email protected]
