Why Conventional Processes Hinder Tech Transfers
Systems don’t talk. MES, LIMS, SAP, and QMS stay siloed, hiding critical data.
Paper delays feedback. Manual batch records reveal problems weeks too late.
Timeline illusions. Six‑month targets stretch to 18 as rework snowballs.
Imagine a Continuous, Knowledge‑Centric System
Treating tech transfer as a hand‑off event blinds organizations to the real cost: every missing detail triggers rework, deviations, and revenue loss. When batch feedback travels slower than decisions, deadlines slip.
What’s missing is a single, unified platform that captures every parameter, decision, and change in real time. When development, quality, and manufacturing share live data, scale‑up hurdles shrink from months to days—and every month saved can mean $3 million to $30 million in revenue gains.
The Foundation for
Right-First-Time Transfers
ValGenesis Process Lifecycle Suite delivers:
- Structured yet adaptable workflows—standardize scale‑up tasks while adapting to your own processes.
- Unified knowledge management—all specs, limits, and history in one place, instantly traceable.
- Live CPV dashboards—early drift signals trigger corrections before they cost batches.
- Automated risk and impact assessments—proactively flag scale‑up pitfalls to prevent delays and support science-based justifications.
The Payoff: Trim 6–12 months from your tech transfers, converting lost launch windows into revenue. Slash batch failures and deviations thanks to effective process and analytical method development paired with real‑time feedback loops. And last but not least, show regulators a clear trail.
Empowering Life Sciences
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 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.
Learn MoreReady to Make Every Tech Transfer a Competitive Advantage?
Book a 15‑minute demo and see how ValGenesis unites your data, collapses timelines, and turns saved months into revenue.
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