The strategic alliance will offer global pharmaceutical companies a streamlined, software-based solution to enhance quality assurance across their global supply chains
San Francisco, February 28, 2023: ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), and Rephine, global experts in quality assurance and GxP compliance, have partnered to deliver compliance solutions to help global pharmaceutical companies enhance quality assurance (QA) across their supply chains.
Rephine has comprehensively supported the pharmaceutical, biotech, and medical device industry for more than 25 years in its validation/qualification needs, in line with the highest technical and quality standards, and current practices. Its optimized methodologies and state-of-the-art documentation satisfy the most stringent requirements of inspectors conducting audits for a wide range of health authorities and clients.
ValGenesis is the market leader in enterprise Validation Lifecycle Management Systems (VLMS), helping the world’s leading life sciences companies enforce compliance and standardization with 100% digital, risk-based validation software.
Under the new partnership, Rephine will implement and manage next-generation digital validation and manufacturing intelligence software tools developed by ValGenesis to enhance QA. Together the two companies will provide an integrated governance approach to managing risk and strengthening compliance across the supply chain.
“ValGenesis and Rephine are collaborating to help life sciences companies enforce standardization and consistency in validation across their supply chains. Our joint solutions will help these organizations meet their compliance obligations, reduce risks, increase efficiency, and lower the cost of ensuring quality,” says Bo Olsen, ValGenesis’ SVP of Partners. “This powerful partnership, which leverages the strengths of both our companies, creates compelling value for customers.”
“At Rephine we are accelerating the growth of our international consulting services, focusing on our deep expertise in the digitalization of QA and compliance. This strategic partnership with ValGenesis, the global leader in VLMS, is the ideal combination of expertise and technology to deliver optimum solutions that address our clients’ business challenges,” says Adam Sherlock, Rephine’s CEO.
“The state-of-the-art design of ValGenesis’s solutions, combined with Rephine’s deep experience in validation and qualification processes, unlock the door of validation best practices for customers while also enhancing their internal processes.”
Rephine is a firm of deeply experienced GxP consultants, auditors and practitioners. The company proactively helps pharmaceutical, biotech and medical device companies with all aspects of their manufacturing and supply chain quality assurance and associated business process optimisation. Widely acknowledged to be the gold standard in its field, Rephine has been providing these specialist quality assurance services for more than 25 years. For more information, visit www.rephine.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 www.valgenesis.com
Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026, [email protected]
Carina Birt, Sarum Life Sciences, 07970 006624, [email protected]