AI-powered Capabilities Set to Redefine the Speed, Efficiency, Compliance, and Cost of Validation in Life Sciences
SANTA CLARA, Calif. ― March 27, 2025 ― ValGenesis, the global leader and first mover in digital validation lifecycle management, will unveil its latest breakthrough, VAL: AI-Enabled Validation Assistant, at INTERPHEX 2025. Designed to fundamentally transform how validation is conducted in regulated life sciences companies, VAL is an intelligent assistant that automates validation document creation, enables right-first-time execution, and drives exception-based reviews―dramatically reducing cycle times and costs.
With the introduction of VAL, ValGenesis is setting a new industry standard, eliminating inefficiencies, reducing manual work, and ensuring audit-ready, compliant validation at unprecedented speed and scale.
Faster Time to Market and Cost Savings
VAL helps life sciences companies cut validation costs, accelerate product launches, and enhance regulatory alignment, all while improving data integrity and reducing the risk of human error. By leveraging existing validation documents and enterprise data, VAL dynamically generates validation protocols and updates based on the specifications, regardless of site location, document format, or language, enabling global standardization at scale. What once took weeks now takes minutes. Validation documents are generated up to 80% faster, while execution time is slashed through automated result population and image-based verification.
VAL also transforms the review process. Powered by its Smart Anomaly Detector, the system parses and compares evidence in real time, including images, snapshots, and file attachments, flagging only exceptions for review. This “review by exception” model reduces validation review cycles from weeks to hours, empowering quality assurance teams to focus on what matters most.
Digital validation has already eliminated paper and reduced validation timelines by more than 50%. AI-enabled validation takes it further—cutting validation time and cost by up to 80% compared to manual paper-based processes. It ensures a right-first-time execution model and enables real-time decision-making at every step of the validation lifecycle.
A New Era of Validation Speed
Faster validation means faster product launches and quicker revenue realization. In high-stakes markets, even a three-month delay in launching a blockbuster therapy can result in $50 million or more in lost revenue. As operations scale, validation complexity and costs often skyrocket, but AI-powered digital validation ensures predictable, scalable, and efficient processes.
“AI-enabled validation is the next frontier in digital transformation for life sciences,” said Dr. Siva Samy, CEO and Chief Product Strategist at ValGenesis. “With VAL, we’re giving our customers a smarter, faster, and more scalable way to manage validation, eliminating legacy inefficiencies while
keeping pace with evolving global regulations. This is the future of validation, and we are proud to lead it.”
Industry Momentum and Early Access
The life sciences industry is already recognizing the transformative potential of AI. Dev Dutta, Senior Director of Computerized Systems supporting GMP and GLP environments at AmplifyBio, shared his insights:
"AI has the power to significantly reduce costs and cycle times for the validation and qualification of computerized systems, equipment and processes. It enhances data integrity while minimizing compliance risks, ultimately improving efficiency, accuracy, and consistency in validation. We’re excited to see ValGenesis driving these innovations forward. 'Quality by design' is our motto, and we love how these AI capabilities further strengthen ValGenesis as a platform to bring that vision to life."
To support early adoption, ValGenesis is launching an Early Adopter Program, giving select customers the opportunity to test AI-enabled workflows and provide feedback prior to full-scale release. This collaboration ensures that VAL is optimized for real-world use cases across diverse GxP environments.
See VAL in Action at INTERPHEX 2025
ValGenesis solution engineers will be offering exclusive, hands-on demos of VAL at INTERPHEX 2025. Attendees can reserve a personalized one-on-one demo at https://www.valgenesis.com/lp/time-to-meet-val.
ABOUT VALGENESIS INC.
ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life sciences 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 https://www.valgenesis.com/
For more information, contact:
Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026, althea.dsylva@valgenesis.com