Spreadsheets Shouldn't Dictate Your CMC Development Timeline
Digitalize your QbD process once—gain speed, accuracy, and regulatory confidence forever.
Challenges with CMC Development
Scattered data kills consistency. Disconnected docs and siloed teams create conflicting CQAs, CMAs, and CPPs.
Scattered data kills consistency. Disconnected docs and siloed teams create conflicting CQAs, CMAs, and CPPs.
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.
Trusted by
Customer Testimonials
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
I hosted an FDA inspection at my former company. Seeing the outputs the ValGenesis system provided sold me on the solution. The two FDA investigators conducting the inspection were familiar with ValGenesis and liked the system. They were pleased we had a standardized tool for validation management. That helped us tremendously.
Jeff Masten
COO
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.
Learn MoreReady to Stop Bleeding Hours and Dollars on Validation—and Breeze Through Audits?
Book a 15-minute demo and watch ValGenesis cut your CQV timelines.