ValGenesis and Hitachi Industry & Control Solutions Join Forces to Revolutionize Digital Transformation in Japan’s Life Sciences Sector

SANTA CLARA, Calif.--( BUSINESS WIRE )-- ValGenesis Inc., the global leader in enterprise validation lifecycle management systems (VLMS), and Hitachi Industry & Control Solutions, Ltd. (Hitachi Industry & Control Solutions), are thrilled to announce a strategic partnership aimed at transforming Japan's life sciences companies through innovative digital validation solutions. This collaboration unites ValGenesis’ industry-leading digital validation platform with Hitachi Industry & Control Solutions’ extensive experience and reach in Japan, empowering companies to accelerate drug development, enhance regulatory compliance, and deliver improved patient outcomes.

Hitachi Industry & Control Solutions, founded in 2014, has a longstanding history of driving societal advancements through its extensive portfolio of cutting-edge technologies. Based on the operational technology (OT)*¹ that Hitachi Industry & Control Solutions has experienced over many years, the company provides solutions to help create new value for customers in industrial fields such as manufacturing and social infrastructure. This integration of technology, expertise, and social impact underscores the company’s commitment to resolving complex issues and creating new value for society.

“We believe that this collaboration has made it possible to strongly promote digital transformation in life sciences companies. Hitachi Industry & Control Solutions, Ltd., in collaboration with Hitachi, Ltd., has introduced HITPHAMS, a manufacturing and quality management system for Hitachi, Ltd. MES (Manufacturing Execution System) and LIMS (Laboratory Information Management System) products for the pharmaceutical and medical device manufacturing industries, to more than 100 sites to promote the digitalization of manufacturing and quality control,” said Yasuyuki Suzuki, deputy general manager and chief operational technology officer of the Industrial Solution Group at Hitachi Industry & Control Solutions, Ltd. “On the other hand, for customers, validation management has become an issue which is essential when introducing systems and equipment. ValGenesis VLMS^® is a product that can digitize this customer issue, and we would like to contribute to further efficiency and quality improvement for customers through collaboration between our companies.”

ValGenesis has consistently set the industry standard in digitized validation. Currently adopted by over 500 GMP manufacturing sites worldwide, the ValGenesis platform supports life sciences companies in expediting product development, achieving regulatory compliance, and implementing standardized, risk-based digital validation processes. By doing so, ValGenesis enables companies to transform their approach to compliance and validation programs in a fully digital, efficient, and scalable way.

In their combined effort, ValGenesis and Hitachi Industry & Control Solutions bring together a powerful blend of technological prowess, innovative solutions, and a global reach. This partnership delivers a comprehensive, future-ready digital transformation solution designed to meet the life sciences industry’s evolving needs in Japan. Hitachi Industry & Control Solutions’ established expertise in Japan’s life sciences sector, together with its strengths in IT systems, equipment, and validation services, perfectly complements ValGenesis' leading-edge validation platform, creating an unparalleled solution that will drive value for life sciences organizations at every stage.

"Our collaboration with Hitachi Industry & Control Solutions marks a pivotal moment for the life sciences sector in Japan, allowing companies to accelerate time to market with the most advanced digital validation platform in the industry," said Dr. Siva Samy, CEO of ValGenesis. “Together, we’re committed to empowering life sciences companies to deliver safe, effective healthcare solutions through streamlined, fully digital processes, raising the bar for quality and patient outcomes.”

Through this collaboration, Hitachi Industry & Control Solutions will leverage ValGenesis VLMS, the leading digital validation platform for life sciences, to optimize validation processes for Japanese companies. Together, they aim to accelerate the development and delivery of safe, effective healthcare solutions that meet the highest standards in quality and regulatory compliance.

“We are very excited about the partnership with Hitachi Industry & Control Solutions and the new opportunities it presents for supporting our Japanese clients with advanced digital validation solutions,” said Bo Olsen, ValGenesis’ senior vice president of partners. “Together, we are poised to empower life sciences companies across Japan to embrace the benefits of digital validation and lead the way in transforming the healthcare landscape.”

NOTE: *¹ OT (Operational Technology): Control and operation technology

ABOUT HITACHI INDUSTRY & CONTROL SOLUTIONS, LTD.

Hitachi Industry & Control Solutions is a major company that supports the industrial and distribution businesses of the Hitachi Group. Based on OT (Operational Technology) that the company has cultivated over many years, they provide various solutions that support the creation of new value in the businesses of their customers in the industrial and social infrastructure fields, including the manufacturing industry. Through consulting based on experience working with customers, the company identifies issues together and solves them with solutions that combine products and technologies. For more information, visit https://www.hitachi-ics.co.jp .

ABOUT VALGENESIS INC.

ValGenesis Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life sciences 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/

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