Global Pharma Giant Goes Paperless in the Validation Process to Support Remote Validation, Driven by ValGenesis VLMS
Sep 21, 2020, 08:37 ET
SAN FRANCISCO, Sept. 21, 2020 /PRNewswire/ -- ValGenesis Inc., a market leader in Enterprise Validation Lifecycle Management Systems (VLMS), today announced that a global pharma giant has gone live with ValGenesis VLMS – the industry's most trusted electronic validation lifecycle management system. Operating in over 20 countries, this company is the U.S. headquarters of a Japanese pharmaceutical giant that researches, develops and markets pharmaceutical products and therapies for patients with critical illnesses across the globe.
ValGenesis digitized and standardized the company's validation process and is further expanding the system across the company's sites in the U.S., Germany and Japan. ValGenesis provides the industry's most advanced VLMS solution which enabled this client to manage a 100% paperless validation lifecycle process. ValGenesis VLMS helps remove complexities throughout the validation lifecycle, including validation impact through change control management, thereby maintaining the validated status of the company's larger ERP application and other GxP systems while driving dynamic data creation.
The client has stated that system performance has been very positive, especially as validation engineers can execute validation protocols remotely, and reviewers can now review and sign off on documents from anywhere across the globe – a huge advantage in these times when the workforce is dispersed and required to Shelter-in-Place at home. With time and effort for organizing approved documents being reduced by almost half, users leveraging the ValGenesis validated Cloud say that, "execution of protocols would be nearly impossible without ValGenesis to keep us on track, more especially in these times when we must work remotely." Covering the entire corporate validation lifecycle process, ValGenesis VLMS is delivering the latest technology solutions that are validated, fully configurable and rapidly deployable through its validated, private, and secured Cloud.
"The challenge lies not only in the initial validation of systems and processes but in maintaining the validated status throughout the life cycle of these systems and processes. That's where the ValGenesis VLMS provides value by sustaining harmonized validation processes. Our client wanted to meet both internal and external compliance requirements especially in change management, quality assurance and regulatory compliance, and the ValGenesis VLMS was able to deliver on those stringent requirements simply, efficiently and very cost-effectively," says Narayan Raj, Sr. Vice President of Global Sales & Operations at ValGenesis, Inc.
About ValGenesis
ValGenesis, Inc. is the inventor of an innovative software platform that serves as the foundation for managing compliance-based validation activities in Life Science companies. ValGenesis, Inc. provides the first enterprise application that manages the corporate validation lifecycle process. As the only system for managing validation execution and approval 100% electronically, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award. ValGenesis solutions are fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. For more information, visit www.valgenesis.com
Further information:
Althea D'Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026, [email protected]
SOURCE ValGenesis Inc.
