ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), and Validator K.K., a reputed Japanese validation products and services company, have entered into a strategic reseller partnership that leverages Validator’s unique on-site validation services model for the Japanese life sciences sector.

Established in 2015, Validator is recognized for its commitment to quality and continuous improvement, as evidenced by its ISO9001 certification. The company’s unique business model, featuring on-site validation services, has been well-received by companies that find it challenging to secure in-house validation staff, have high travel costs, or require equipment that needs expertise and cannot be entrusted to other companies.

ValGenesis is the industry innovator of digitized validation. The company’s platform, which includes its flagship VLMS offering, is used in over 100,000 GMP systems worldwide, helping life sciences companies advance their digital transformation strategy, enforce compliance, and enable standardization with 100% digital, risk-based validation software.

Validator’s services solve a range of key issues within the pharmaceutical industry, making them a go-to partner in Japanese life sciences. As a ValGenesis reseller partner in Japan, customers can leverage Validator’s on-site services model alongside ValGenesis VLMS, the industry standard digital validation platform.

This unique service model presents exclusive benefits to Validator customers, including on-demand expertise with flexible scaling up or down based on customer needs, comprehensive risk management and risk mitigation through the team’s extensive service experience, increased budget flexibility, and more importantly, improved quality assurance.

“With Japan being the world’s second-largest pharma and medtech market and a key innovation center for the global life sciences industry, ValGenesis is honored to enter this market through a reliable partner, like Validator,” says Bo Olsen, ValGenesis’ SVP of Partners. “Through Validator’s on-site service model, customers can now access world-class smart solutions, like ValGenesis VLMS, that supports digital transformation and brings value to each step of a company’s validation and manufacturing processes. Our partnership with Validator presents the ideal approach to digitization that is adapted specifically to the country’s and industry’s conditions.”

“We eagerly look forward to this unique collaboration with ValGenesis, a leading enterprise in validation lifecycle management systems. Paper-based validation is still common in Japan, however with the recent updates regarding GMP audits, paper-based validation management is reaching its limits. We are honored to build this partnership in response to customer and government requirements through ValGenesis VLMS,” says Tamura Hiroki, Representative Director of Validator K.K., Japan. “Japan’s top ranking in the global pharmaceutical market is supported by tireless R&D and quality control efforts. With Japan's current shrinking population and labor shortage, productivity improvements are inevitable. Digital transformation is necessary to accelerate adaptation with sustainable growth.”

ABOUT VALIDATOR

Established in 2015, Validator K.K. is a Japanese company specializing in providing validation services to the life sciences sector in Japan. The company’s core business includes the development and sales of validation tools, as well as offering validation consulting. The company’s unique business model that focuses on on-site validation services is particularly beneficial for companies that find it challenging to secure in-house validation staff, have high travel costs, or require equipment that needs expertise and cannot be entrusted to other companies. Validator K.K. is also ISO9001 certified, demonstrating their commitment to quality and continuous improvement. The company’s services are designed to solve a range of problems, making them a reliable partner in the life sciences industry. For more information, visit https://validator.co.jp/en/.

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 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/.

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