Santa Clara, July 16, 2024, ValGenesis, Inc.
ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), and Pharmasys, a leading life sciences GxP systems consulting firm based in France, have entered into a strategic partnership to enhance overall compliance practices within the life sciences industry in France and Europe.
Pharmasys specializes in engineering, quality assurance, GxP compliance, and data integrity of computerized systems in compliance with regulatory requirements.
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.
As leaders in their field, ValGenesis and Pharmasys are joining forces to elevate compliance practices in European life sciences. By leveraging ValGenesis's cutting-edge tools, such as ValGenesis VLMS, the industry standard for digital validation across life sciences, Pharmasys can optimize validation process, guaranteeing seamless compliance with worldwide regulations for customers.
“Pharmasys’ exceptional expertise and pragmatic approach to regulatory compliance have earned them respect and recognition within the field,” says Bo Olsen, ValGenesis’ SVP of Partners. “Our companies bring cutting-edge solutions to the table creating a seamless digital transformation experience for customers. In this sense, we are more than collaborators as we don’t just serve customers but help in shaping their future.”
“Merging our mature IT quality assurance experience to the powerful ValGenesis platform will bring value to our life sciences customers, enabling efficient computer system validation activities as an additional key step to the paperless path, mastering digitalization,” says Jérome Larfi, Pharmasys’ CEO.
ABOUT PHARMASYS
Pharmasys, a leading consulting firm in France, specializes in engineering, quality assurance, GxP compliance, and data integrity for computerized and automated systems in the life sciences sector. Their expertise spans pharmaceuticals, biotechnology, cosmetics, and medical devices. Pharmasys provides project management support, quality assurance, validation, and training services. Their approach adheres rigorously to ISPE® guidelines and leverages methods honed through extensive experience. As a result, they effectively address regulatory requirements, including FDA guidelines, 21 CFR Part 11, cGMPs, BPx, data integrity guidance, 21 CFR Part 820, CE Mark, ISO 13485, ISO 14971, and IEC 62304. Pharmasys belongs to Infogene, a digital services company with a strong footprint in the life sciences industry. For more information, visit https://www.pharmasys.fr/
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/
Further Information
Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026, althea.dsylva@valgenesis.com
Audrey Godimus, Lifesciences Technical Director, +337 69 09 27 56, agodimus@pharmasys.fr