ValGenesis Awarded Patent on Paperless Validation Lifecycle Management Process

ValGenesis Inc., a global developer of Enterprise Validation Lifecycle Management Solutions (VLMS), has been issued a patent on paperless validation, #9,720,687. The patent granted by the U.S. Patent and Trademark Office (USPTO) focuses on “Validating and Maintaining Respective Validation Status of Software Applications, Manufacturing Systems and Business Processes.” This patent recognizes the innovation behind ValGenesis’ approach for managing the validation process in life science companies as a lifecycle process that maintains the validated status throughout the life of GxP systems and processes.
 
“This patent protects our proprietary and innovative approach for managing the validation lifecycle process as paperless. The paperless validation lifecycle management process is a new, rapidly growing multi-billion dollar market in the life sciences industry. As a first mover in this space, the patent strengthens our position as a thought leader and major player,” said Dr. Siva Samy, CEO and chief product strategist of ValGenesis.
 
ValGenesis VLMS manages all types of validation processes and provides a holistic view of the validation process throughout the organization. This consists of validation activities accessible in real-time from a convenient dashboard within ValGenesis VLMS and provides a direct line to validation tasks, inventory, work in progress, validation calendars, projects and reports. Overall, it provides a 360-degree view of GxP systems and processes by site.

“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 are delighted that USPTO has awarded this patent, which allows for maintaining our approach towards the paperless validation lifecycle management process,” commented Robert van der Laan, vice president of professional services at ValGenesis.
 
“ValGenesis has proven its value to all types of life sciences companies as a configurable system to manage any type of validation lifecycle process. After seeing the benefits of the system at the site level, over 90 percent of our clients expanded the use of the system across their organizations so as to manage all types of validation processes. We strongly believe this patent will protect our  approach and commitment towards delivering a paperless validation lifecycle management solution and help maintain our leadership position as the de facto standard for validation lifecycle management processes,” said Narayan Raj, vice president of sales and marketing at ValGenesis.

ValGenesis Inc. created a software platform serving as the foundation for managing compliance-based validation activities in life sciences companies. ValGenesis provides the first enterprise application to manage the corporate validation lifecycle process. As the only system for managing validation execution and approval 100 percent electronically, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award. The solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements.