SAN FRANCISCO & COPENHAGEN, Denmark—ValGenesis Inc., the inventor of a software platform serving as the foundation for managing compliance-based validation activities in life-science companies, has entered a strategic partnership with NNIT, which provides a wide range of IT services and solutions.
Because validation activities in the life sciences tend to be entirely manual and paper-based, the process can be inefficient, costly and error-prone. Cloud-based Enterprise Validation Lifecycle Management Solutions (VLMS) from ValGenesis allow companies to manage their entire IT validation lifecycle electronically and enable rigorous compliance, data integrity and consistency while reducing validation cycle time significantly, according to ValGenesis.
Both NNIT and ValGenesis have been operating in the computer system validation space for a while now, and recognized each other as key players. While NNIT has a strong focus on IT services for life sciences, including technology consultancy services, ValGenesis offers a robust software portfolio that fully automates the validation lifecycle and requires zero paper-based activities. Both parties recognized potential synergies and “that our offerings complement each other very well in the life-sciences market,” according to a company source. The companies have worked together in the U.S. market, where ValGenesis’ software has been implemented by 10 out of the top 20 pharmaceutical companies.
NNIT is a global IT service provider for life sciences, and ValGenesis provides the software solution and expertise around it. With more than 20 years in the life-sciences space, NNIT has experience and know-how that clients can benefit from while implementing a new quality management system. NNIT has about 400 clients, of which around 150 are located outside Denmark. About 20 percent of them are international life sciences clients.
ValGenesis, on the other hand, offers its VLMS to covers all aspects of the validation lifecycle in a fully automated, paperless manner. There is no other software provider in the market that currently offers the level of coverage that ValGenesis VLMS does, the company source noted. Recently, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association New Innovative Technology Award. The company’s solution fully complies with U.S. FDA 21 CFR Part 11 and Annex 11 requirements.
Bo Olsen, general manager of NNIT US, commented, “We partner with the first mover in this niche area to help more life-sciences companies say goodbye to paper. ValGenesis’ software is developing into a de-facto standard on how validation should be assured and managed, because companies adopting ValGenesis are realizing significant improvement (consistency, compliance and cycle time reduction) in their validation processes.”
Dr. Siva Samy, CEO at ValGenesis, added, “Not only does ValGenesis allow life-sciences companies to manage their validation processes electronically, it significantly reduces the validation cycle time and cost, eliminates potential data integrity issues in the validation process, enables standardization and enforces consistency and compliance in the corporate validation process. We look forward to expanding our footprint and partner[ing] with NNIT, a leading provider of IT services and consultancy to the global life-sciences industry with exceptionally strong positions in Europe and China.”
As the preferred global partner to ValGenesis, NNIT will integrate the paperless validation software within its suite of services for the pharmaceutical and biotech industry. The training and cooperative efforts will focus on NNIT’s more than 200 validation consultants and sales force in Europe.
While the primary focus remains on expanding company footprints in the U.S. and European markets, both NNIT and ValGenesis have determined that a key component behind the success of this partnership relies on helping users and clients to embark on their digital transformation within life cycle management. Because many companies moving away from paper-based processes recognize the true value of a fully automated validation framework, the companies will meet their clients together and present case studies and lessons learned via several white papers and conference presentations in the coming months.
According to the two companies, “NNIT is recognized as a major consulting player in the life-sciences industry, with a promising pipeline in the U.S. as well. ValGenesis has a strong reputation and presence in the U.S. with many years of successful implementation experience. Together, we can establish ourselves as leaders in the CSV [computer system validation] space, globally.”