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.
Trusted by 30 of the Top 50 Life Sciences Companies
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
Validation Engineer
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
Head of Global Project Statistics CMC Technical R&D
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
Validation Supervisor
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
Global IT Data Integrity Manager
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
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
Director QbD & Pharmaceutical SciencesValGenesis Smart GxP™
Validation Lifecycle Suite
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.
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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.
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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 MoreProcess Lifecycle Suite
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.
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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
Emmanuel Cansino
Industry Solutions Group
Wednesday, August 06 2025
Why is Manual Validation Holding you Back? The Evolution of AI-Driven Validation in Regulated Industries
Register
Sachin Maled
Industry Solutions Group
Wednesday, July 16 2025
Achieving Regulatory Readiness: How to Minimize Audit Stress
Register
Daniel Pais
ValGenesis Consulting
Wednesday, June 25 2025
Reimagining Tech Transfers: How Automation and AI Assessments Deliver Smoother Processes
Watch
Maria Batalha
ValGenesis Consulting
Wednesday, July 02 2025
Redefining Compliance: Benefits of Running CPV in Real Time
Watch
Margarida Ventura
ValGenesis Consulting
Wednesday, May 28 2025
Revolutionizing CMC in Drug Development: How to Reduce Errors and Delays in Quality by Design
Watch
Kenneth Pierce
Wednesday, May 14 2025