Icelandic Biotech Firm Selects ValGenesis’s Cloud-Based Electronic Validation Lifecycle Management System
SAN FRANCISCO, Nov. 26, 2019 -- ValGenesis, Inc., a market leader in Validation Lifecycle Management Systems (VLMS), announced today that an Iceland-based biotech firm has selected ValGenesis's VLMS as their platform for validation process management across multiple sites.
A fully integrated specialty biopharmaceutical company, it focuses exclusively on the development and manufacture of high-quality biosimilar products. The company specializes in biogeneric product creation across the entire value chain, from cell line development to commercial manufacturing.
Keen to start creating leaner, more efficient validation processes, the company's IT and Validation department examined validation activities across their sites and realized the need to move away from the prevailing paper-based validation process that was susceptible to redundancies and inconsistencies. They began researching alternative solutions that could help them automate the validation process without compromising usability, data integrity and regulatory compliance requirements. They found that ValGenesis offered the most comprehensive, fully compliant, electronic, cloud-based SaaS solution that could track and streamline validation processes while increasing efficiency and ensuring both data integrity and compliance. With robust flexibility, web services, and scalability tools built into the core solution, ValGenesis's VLMS easily integrates with other software systems to provide seamless, end-to-end validation lifecycle management.
"Paper-based validation activities lead to huge compliance risks and compromise a company's ability to bring products to market on time. ValGenesis is committed to helping this company and all our clients in automating their CSV and Equipment validation processes to realize the best return on investment," says Narayan Raj, Sr. Vice President of Global Sales & Operations at ValGenesis Inc. "ValGenesis's cloud-based VLMS is a complete fit to the client's IT ecosystem and easily facilitates the level of automation required to deliver validation process efficiency. In addition, the company's Quality leaders can now monitor the validation status of all instruments, equipment and software systems across their sites, remotely and in real-time. We look forward to growing this partnership as we continue to meet all their validation lifecycle management needs."
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.