Process Excellence.
From Design to Verification.
ValGenesis Process Lifecycle Suite combines iCMC and iCPV to unify the process lifecycle - powering smarter decisions, seamless tech transfer, and sustained product quality.
The Upgrade CMC Deserves.
Join the life sciences leaders using the ValGenesis Process Lifecycle Suite to remove barriers to innovation and accelerate delivery - by making process lifecycle execution consistent, connected, and efficient.
Customer Testimonials
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
Used By Life Sciences Leaders Worldwide
Process
Lifecycle Suite
Process Excellence.
From Design to Verification.
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.
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Science and data-driven process design
Apply QbD and risk-based frameworks to build quality into every stage of drug development.Real-time performance oversight
Monitor CPPs and CQAs continuously to detect trends and ensure consistent product quality.Confidence in change control
Support post-approval changes with data-driven risk assessment and full traceability.
Resources
Integrating Digital Transformation and Quality by Design for Enhanced Pharmaceutical Development
Discover how digital platforms paired with QbD speed pharma development ...
Digital Transformation in CDMOs: Streamlining Tech Transfer Processes
Reduce tech transfer delays in CDMOs with digital workflows and data ...
Transforming Pharmaceutical Development: Combining Digital Platforms and QbD Principles
Cut paper bottlenecks with digital QbD workflows to speed risk ...
Smarter by the Second: How Real-Time Monitoring is Redefining Pharma and Biopharma Manufacturing
Catch process drift early with real-time monitoring, support PAT, and ...