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.
Empowering Life Sciences
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
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 SciencesApplications
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-based 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
Industry Insight
Risk and Data as Knowledge Enablers: A ...
One of the goals of industry 4.0: to have an integrated end-to-end and ...
ReadIndustry Insight
A Roadmap for Implementing Analytical QbD
AQbD improves Analytical Target Profile robustness and makes drug ...
ReadWebinar
Data-Driven Risk Management: a Practical ...
In this webinar, we will explain how ICH Q9 (R1) introduced the need to ...
WatchIndustry Insight
Removing Bias from Risk Assessment
In this Industry Insight we introduce you to an innovative framework that ...
ReadWebinar
Digital Transformation in CDMOs: ...
Tech Transfer processes are an integral part of (bio)pharmaceutical ...
WatchIndustry Insight
Digital Transformation in CDMOs: ...
In the fast-paced world of pharmaceutical manufacturing, the power of ...
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The Toolbox for an Effective Tech Transfer
The implementation of digital tools in (bio)pharmaceutical Technology ...
WatchWebinar
A Roadmap to Digitalize Your Control Strategy
Transforming traditional control strategies into digital frameworks is ...
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