ValGenesis, Inc. and Xevalics Consulting have partnered to deliver best-in-class digital validation solutions for the life sciences industry across the U.S.
ValGenesis is the market leader in enterprise Validation Lifecycle Management Systems (VLMS), helping the world’s leading life sciences companies enforce compliance and enable standardization with 100% digital, risk-based validation software.
Xevalics is a consulting company specializing in computer software assurance (CSA), computer system validation (CSV), and risk management. Xevalics has years of experience in strategically transforming complex problems into manageable and tractable projects.
In this partnership, Xevalics will implement and manage next-generation digital validation tools developed by ValGenesis, enabling clients to further strengthen CSA and risk and compliance across the GMP lifecycle. With ValGenesis technology, Xevalics will serve a wider network of life sciences companies across the U.S. and the globe. This combined expertise enables pharma companies to bring products to market faster in accordance with the guidelines of Industry 4.0 and MISE.
“Pharmaceutical manufacturing is rapidly innovating and companies are finding new ways to create value, but GMP compliance remains the foremost concern,” says Bo Olsen, ValGenesis’ SVP of Partners. “To meet stringent regulatory requirements and to get their products to market more safely and quickly, it is crucial that companies embrace digitalization. Our partnership with Xevalics leverages both our strengths to provide a true digital validation strategy that creates compelling value for customers,” he stated.
“Many companies in the life sciences industry are experiencing uneasy moments determining when and how to start fully incorporating CSA practices,” said Ricardo Torres-Rivera, CEO/President of Xevalics. “Together with ValGenesis, our goal is to empower clients to evolve their business and harness the power of the FDA’s CSA initiative by embracing paperless, agile, and risk-based digital validation processes. With this partnership, we are propelling our capabilities to bring a market leader VLMS technology, superior project management, validation, quality, and regulatory knowledge to achieve agile and successful implementations for faster and greater benefits to our clients,” he stated.
About Xevalics Consulting
Xevalics is a consulting company specializing in computer software assurance (CSA), computer system validation (CSV), risk management, data integrity, quality, compliance and regulatory services, digital transformation and information technology (IT), and cloud computing and cybersecurity. Xevalics is a forward moving company providing strategic value-added solutions for the most complex challenges by enriching the relationship between people and technology. For more information, visit https://xevalics.com/.
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/.
Ricardo Torres-Rivera, Xevalics Consulting, +1 787-603-2946,
Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026,
SOURCE ValGenesis Inc.