End Paper.
Ensure Quality.
Be First to Market.
ValGenesis Smart GxP™, is the first AI-enabled digital validation platform to seamlessly unify development, commissioning, qualification, validation, and continued process verification.
Be Among the Industry Leaders
Join the 30 of the top 50 life sciences companies who use the ValGenesis Smart GxP™ Platform to remove barriers to innovation and accelerate the path from lab to patient.
Customer Testimonials
We chose ValGenesis because they were a known and trusted vendor. We had limited time and resources, and we knew the quicker we could implement the solution, the sooner we’d start realizing value from it.
Joshua Pelina
We work with ValGenesis iCMC to digitalize our QbD framework within GSK for the development of new vaccines. We are confident that iCMC will be key for simplification, acceleration, and knowledge management.
Hervé Gressard
Implementing ValGenesis iCPV has transformed our approach to CPV. The integration of our data systems and the comprehensive training from the ValGenesis team have empowered our users, ensuring we meet regulatory standards while enhancing efficiency and data integrity.
Patricia Watanabe
Working with ValGenesis was great. They helped us align the system with our new CSV program and uncover opportunities for process improvements and efficiency gains to maximize value.
Jeff Onis
Our ERP upgrade would touch every department in the company. This was the ideal opportunity to transition from paper-based to digital validation, and now we’re reaping the benefits: signoff documents organized in one place, simplified review and approval, no more issues deciphering handwriting, one-click access to deviation reports, reduced printing costs—all totaling up to a successful outcome.
Mabel Santana
When we decided to go with iCMC, we wanted to have the roll-out concluded within six months. The support we received from the team, their willingness to accommodate our requests and timelines, and their expertise in resolving all the issues that came up during the project was amazing.
Dr. Iris Ziegler
ValGenesis provides an exceptionally detailed level of configuration for user roles, which we found to be incredibly powerful and effective.
Laurie Lipper
Legibility concerns were a common problem when delivering hard-copy qualifications that were documented using pen and paper. And simple, common mistakes like accidentally writing 2024 instead of 2025 after the year change are a big deal in a regulated industry. With ValGenesis, date attributions will always be correct, and legibility problems are solved.
Jonathan Revere
We used ValGenesis’ vendor testing documentation because it was thorough, and it saved us a lot of time. We estimate saving 100 hours of work, which we reallocated to other parts of the project like training.
Raghav Mathur
I hosted an FDA inspection at my former company. Seeing the outputs the ValGenesis system provided sold me on the solution. The two FDA investigators conducting the inspection were familiar with ValGenesis and liked the system. They were pleased we had a standardized tool for validation management. That helped us tremendously.
Jeff Masten
What our Customers Say
We used ValGenesis’ vendor testing documentation because it was thorough, and it saved us a lot of time. We estimate saving 100 hours of work, which we reallocated to other parts of the project like training.
Raghav Mathur
Senior Validation Engineer
Our ERP upgrade would touch every department in the company. This was the ideal opportunity to transition from paper-based to digital validation, and now we’re reaping the benefits: signoff documents organized in one place, simplified review and approval, no more issues deciphering handwriting, one-click access to deviation reports, reduced printing costs—all totaling up to a successful outcome.
Mabel Santana
Compliance Manage
ValGenesis Smart GxP™
ValGenesis Smart GxP™ digitalizes the full lifecycle of drug process design through commercial performance—connecting design, validation, and continuous process insight in one AI-enabled platform. By unifying insights, automation, and built-in compliance across all three stages, Smart GxP empowers teams to reduce manual burden, enhance quality consistency, and accelerate time to market.
iVal
Supercharge validation with ValGenesis iVal™. AI-powered authoring, automated execution, live anomaly flags, and bulletproof traceability slash cycles by up to 80% and cut observations by 90%. From CQV to CSA, you’ll be audit-ready and market-ready faster than ever. iVal takes digital validation to the next level.
Learn More
iClean
Halve cleaning validation timelines and wipe out manual math with ValGenesis iClean™. Automated MACO calculations, ADE-aligned limits, 2D/3D equipment maps, and rule-driven workflows deliver digital, inspection-ready files across all sites. Standardize globally, flex locally, and gain real-time oversight - discover iClean today.
Learn More
iOps
Leave paper logbooks behind with ValGenesis iOps™. Mobile, QR-enabled forms capture every use, cleaning, and calibration event in real time; automated reviews, deviations, and alerts seal compliance gaps. Achieve 100% traceability, trim documentation labor by 70%, and connect ops to quality with iOps today.
Learn More
iCMC
Design robustness, not rework, with ValGenesis iCMC™. Centralized QbD tools link QTPP targets to CQA/CPP analysis, FMEA and HAZOP risk scoring, and ML-powered trend analytics in one traceable hub. Harmonize processes across products, satisfy regulators with confidence, accelerate development, and get to market first.
Learn More
iCPV
Join the world of real-time monitoring with ValGenesis iCPV™. Multivariate analytics, SPC control charts, and guided workflows transform siloed data into early-warning insights, automating CPV reports across sites and batches. Detect drifts before they hurt quality, maintain continuous readiness, and future-proof production - explore iCPV now.
Learn MoreThought Leadership in Life Sciences
Peter Liang
Industry Solutions Group
Wednesday, January 21 2026
How Digital Cleaning Validation Averts Compliance Pitfalls
Register
Emmanuel Cansino
Industry Solutions Group
Wednesday, February 04 2026
Why is Manual Validation Holding You Back? The Evolution of AI-Driven Validation in Regulated Industries
Register
Daniel Pais
ValGenesis Consulting
Wednesday, December 10 2025
Reimagining Tech Transfers: How Automation and AI Assessments Deliver Smoother Processes
Watch
Sophia Vraka
Industry Solutions Group
Wednesday, December 03 2025
AI Powered Validation: How to be Smarter, Faster, and More Reliable
Watch
Margarida Ventura
ValGenesis Consulting
Thursday, November 13 2025
Revolutionizing CMC: Cutting Errors and Delays in Quality by Design
Watch
Inês Victorino
ValGenesis Consulting
Wednesday, November 19 2025