ValGenesis and Pharmasys in Strategic Partnership to Enhance Compliance in European Life Sciences
2024年7月16日 - 10:00PM
ビジネスワイヤ(英語)
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/
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version on businesswire.com: https://www.businesswire.com/news/home/20240716723467/en/
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