SAN FRANCISCO, Oct. 30, 2018 /PRNewswire/ -- ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management Solutions, announced today that it had released Version 4.0 of its 100% paperless Validation Lifecycle Management System (VLMS) that currently manages validation lifecycle processes for life science companies across the globe. ValGenesis, Inc. continues to work actively with clients to consistently incorporate their feedback to continually enhance user experience, real-time collaboration, data integrity, risk assessment and compliance adherence processes.
At the business level, ValGenesis VLMS 4.0 provides improved usability and user experience (UX), portability and collaboration, GxP impact assessment and risk assessment and mitigation features that can help customers significantly reduce validation cycle time and costs. ValGenesis VLMS 4.0 is multi-browser compatible with an online editor. It enables a collaborative review of documents (through the online editor); provides portability (supports mobile devices such as the iPad and Surface across authoring, execution and review stages); and has enhanced system assessment features that integrate GxP assessment, validation standards and risk assessments. All of these can be managed through a new and intuitive user interface (UI) design that provides ease of use and, as a result, increases customer satisfaction.
At the operational level, all modules have been enhanced for streamlined process efficiency with measures based on feedback received from our extensive client base. Here is a sampling of but a few new enhancements:
Users can configure and design their business process at the site level, based on business requirements and approved processes
Configure required deliverables as per the approved master validation plan in a corporate validation process to avoid human errors
Define dependencies and quality gate checks for validation deliverables in a project, even if the project is in progress
Reviewers can collaboratively edit the contents, and the system captures changes in Track Change mode
During paperless execution, users can incorporate objective evidence such as screenshots, images and file attachments, on the fly, through a new execution toolbar
Reporting managers can view the real-time status of both deliverables and the workload of all reportees, helping to both prioritize tasks and facilitate planning workloads at the team level so that all personnel are synchronized at an organizational level
For existing customers, ValGenesis has set up demo features in the ValGenesis Cloud so that they may gain hands-on experience with the power of this new platform.
"ValGenesis VLMS has been trusted by the top 10 out of 20 global life science companies for paperless validation. ValGenesis is committed to continual improvement, and as part of this commitment, it continues to evolve its offerings in line with the evolving needs of our customers and ever changing regulatory requirements, technology landscape and business environments. In collaboration with our current clients, ValGenesis continues to build its leadership position for its Validation Lifecycle Management system, which is being recognized as the de facto standard for supporting a Paperless Validation Lifecycle process. We seek to enhance quality assurance, data integrity, and regulatory compliance while improving the overall efficiency of corporate validation programs," said Dr. Siva Samy, CEO & Chief Product Strategist of ValGenesis, Inc.
"The commitment to continual improvement and innovation visible in VLMS 4.0 is impressive and professionally satisfying," said Dr. Ajaz S. Hussain, Member of the Board of Directors ValGenesis, Inc, and former Deputy Director of CDER - US FDA
"ValGenesis 4.0 has a new intuitive interface that has been received very well by our early adopter customers. Several implementations for ValGenesis 4.0 are already on their way with the first ValGenesis customers expected to go live later this year," according to Robert van der Laan, Vice President Professional Services of ValGenesis, Inc.
"ValGenesis has been a trailblazer as it relates to an electronic Validation Lifecycle Management software for the Life Science industry. The Version 4.0 release of the software is going to emphasize our leadership in the overall completeness of vision and ability to execute as we bring additional efficiency gains to the already significant efficiency gains the system provides over the traditional paper-based approach. I am personally very excited for our customers as they adopt this new version of the software and for the continued growth of ValGenesis Inc.," according to Narayan Raj, Vice President Sales of ValGenesis, Inc.
ValGenesis, Inc. is the creator of an innovative software platform that serves as the 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. 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 in 2005 for being a first mover in paperless validation. The solution is also fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements.