SAN FRANCISCO, Oct. 18, 2022 /PRNewswire/ — Continuing its vision to deliver enterprise-class digital validation technology to every life sciences organization, ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), announced the release of VLMS Express, a next-generation digital validation tool purpose-built for small and midsize life sciences companies.
ValGenesis launched this market-first offering to enable life sciences companies to further their digital transformation efforts with lighter, streamlined solutions. With a changing regulatory landscape and market dynamics asking every company to innovate faster, the imperative for digitization and automation has never been more urgent. The purpose-built VLMS Express delivers enterprise-grade digital validation technology into a rapidly deployed, easily configured cloud application.
The native agility of VLMS Express is ideal for pre-market startups, single-site life sciences companies, engineering and consulting organizations providing validation and C&Q services, and even for fixed capital projects within large companies.
ValGenesis is pioneering a “validation as a service” concept for organizations that need to start small, deploy quickly, and scale without issues. VLMS Express provides focused functionality to author, execute, and approve validation processes while maintaining fully dynamic, living traceability matrices. This pre-configured subset of functionality delivers complete digital validation with built-in best practices learned from over 30 of the top 50 global life science companies.
VLMS Express leverages the security, scale, and speed of the cloud. Customers own their data. They can easily migrate it all from VLMS Express to a full deployment of ValGenesis VLMS as their business sophistication demands. The environment, as well as all application and infrastructure updates, are validated and appropriately certified. It’s designed to be used exactly as an organization needs, without the burden of complex license and service models.
With VLMS Express, clients can go live in days instead of months. ValGenesis also provides 20 days of support and training with six months free access to ValGenesis University.
VLMS Express is attractively priced to go digital in the validation process with an operational budget without the requirement of extensive capital budget planning.
In the past decade, there’s been an explosion of life sciences startups across the globe. To offer robust solutions, these companies must ramp up their digital validation programs while adhering to a risk-based approach to building a culture of quality. To compete, a digital-first mentality is mandatory. But few prioritize the investment in purpose-built digital validation for their GxP lifecycle. VLMS Express is designed for these startups and other small and midsize life sciences companies by enabling them to start fast and cost-effectively.
“Implementing a digital validation lifecycle management solution as soon as a company opens its doors is rare. But we increasingly find that new age life sciences startups are determined to leverage digital automation and other smart factory capabilities from the outset,” says Dr. Siva Samy, CEO at ValGenesis. “Light but powerful, the VLMS Express is just what they need to start efficiently. We are delighted that yet another customer-driven innovation specifically fulfills critical needs of new age life science customers,” he stated.
“Customer success is ValGenesis’ number one priority, and that’s why the VLMS Express was developed to specifically meet the needs of smaller life sciences companies and CDMOs who must meet the high standards of their larger biopharmaceutical customers and those of the FDA,” says Mike Hicks, CTO at ValGenesis. “VLMS Express helps these companies position themselves for rapid growth with their clients who have embraced a quality-by-design, PAT manufacturing model. Digital validation and data integration best practices enforced by VLMS Express is a competitive differentiator for smaller companies making the Pharma 4.0 journey,” he stated.
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. For more information, visit www.valgenesis.com
Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026, firstname.lastname@example.org
SOURCE ValGenesis, Inc