Fremont, CA, March 29, 2017–
ValGenesis, Inc., the world’s leading provider of Validation Lifecycle Management System (VLMS) software solutions, today announced that a globally renowned Medical Device manufacturer will be presenting a case study about their experience with the paperless validation process. In the study, the medical device manufacturer explains how the paperless validation process helped to improve upon their efficiency while also standardizing the validation process across the sites at the IVT Val Week Europe conference in Amsterdam, Thursday March 30th 2017.
“Traditional validation activities with paper-based validation processes stifle innovation, cause compliance issues, invite business risk and have a negative impact on bringing products to the market on time. In contrast, ValGenesis enables all regulated manufacturing companies to manage the entire validation lifecycle process electronically, significantly reducing validation cycle time and cost, and enforcing consistency and compliance in the corporate validation process,” stated Siva Samy, ValGenesis’ Chief Product Strategist. “The flexible scalability and configurability available in the ValGenesis system enables global companies to implement at a single site and expand globally. ValGenesis allows key process stakeholders, including validation, engineering, IT, and SME’s to monitor the validation status of any equipment, analytical instrument, software system or process remotely and in real time for any site. In addition, ValGenesis enables global regulated companies to reuse validation protocols, requirements and data globally across sites, which significantly reduces validation costs and cycle time with improved consistency. ValGenesis looks forward to continuing as a strategic partner and providing a robust framework to meet its clients Validation lifecycle management needs.”
ValGenesis is an innovative software platform designed to provide the foundation for compliance-based validation activities in life science companies. ValGenesis revolutionized Life Sciences in 2004 by advocating a technology solution companies can leverage to significantly improve validation processes and relieve the paper burden of traditional validation. ValGenesis is the first Enterprise application to manage the corporate validation lifecycle and to track validation inventory with real-time validation status. ValGenesis VLMS includes a regulatory framework allowing the enforcement of validation deliverable requirements that meet the validated status. Risk management is integrated and flexible, thus giving companies the ability to leverage standard risk tools to best suit their needs. Reusability is inherent and available at validation protocols and requirement levels, significantly improving efficiency via pre-approvals. Change control and periodic review functionalities help to maintain the validated status of GxP assets. Through an industry peer review committee, the Parenteral Drug Association (PDA) recognized ValGenesis by awarding them the very prestigious New Innovative Technology award. ValGenesis is designed to be fully compliant with US FDA 21 CFR Part 11 compliance requirements.