Challenges with CMC Development
Scattered data kills consistency. Disconnected docs and siloed teams create conflicting CQAs, CMAs, and CPPs.
Manual process and analytical method development is slow and subjective. Hours disappear in meetings and macros—yet blind spots remain.
Spreadsheet errors escalate compliance risk. One bad formula can ripple into failed audits and costly rework.
The Platform You Need
Legacy tools weren’t designed for modern QbD. They can’t map critical attributes end to end, compare risks in real time, or surface trends that cut months from development. Teams burn out chasing versions, regulators lose patience, and every delay compounds cost.
To unlock true QbD, you need a single digital backbone—one place to capture every CQA, CMA, and CPP; one engine to calculate risk; one source of truth that everyone—scientists, engineers, quality, and regulators—can trust instantly.
How ValGenesis Closes the Gap
ValGenesis Process Lifecycle Suite replaces ad hoc spreadsheets with a structured, database‑driven QbD framework. Prebuilt yet flexible workflows map CQAs, CMAs, and CPPs automatically. Embedded Monte Carlo and FMEA engines calculate risk on the fly, while auto‑generated charts and process maps deliver audit‑ready evidence in seconds.
The result?
- Faster CMC deliverables.
- Fewer deviations.
- Verified compliance.
Digital QbD isn’t the future; it’s now—and it’s how leading pharma squeezes months off development, protects margins, and beats competitors to market.
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 Replace Spreadsheets With Efficiency?
Book a 15‑minute demo and see how ValGenesis can cut weeks out of your next CMC project.
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