Challenges With Cleaning Validation
“It’s just compliance.” Cleaning validation is under-leveraged as a driver of operational efficiency.
Paper and spreadsheets obstruct timely data access and reduce lifecycle transparency. Engineers waste hours hunting limits, while hidden errors threaten every batch.
One-and-done mindset ignores lifecycle monitoring. Three successful runs ≠ perpetual control; undetected drift drags OEE and invites 483s.
Manual MACO math delays changeovers. Ad hoc impact assessments stall equipment turns and burn capacity you've already paid for.
The Lifecycle Mindset—and Data System—Built to Claim Back OEE
When cleaning validation is treated as a compliance checkbox, its operational impact is overlooked. Paper processes scatter sampling plans, slow MACO recalculations, and force engineers into impact‑assessment marathons—draining OEE day after day.
What’s missing is a rules-driven, digital system that standardizes worst‑case logic, automates MACO calculations, and logs every sample in real time. With real-time dashboards and integrated workflows, teams shorten changeovers, spot issues early, and reclaim capacity that used to disappear into binders—turning CV from bottleneck to OEE booster.
Step Into the World of Digital Cleaning Validation
ValGenesis Validation Lifecycle Suite digitalizes the full cleaning‑validation lifecycle:
- Automated worst‑case and MACO calculations—science‑based limits without spreadsheet gymnastics.
- Risk-based worst-case identification—risk-based decision trees streamline cleaning requirements without compromising control or compliance.
- Stage‑3 CPV dashboards—real‑time statistical process control flags drift before it becomes a deviation or unplanned downtime.
- Standardized workflows— one rules engine for every site and contractor, protecting OEE everywhere you run.
The outcome? You will recover lost OEE .
Changeover time savings translate into substantial capacity gains. Audit preparation is reduced by up to 90% through fully traceable, digital records. The result is a scalable, future-ready validation framework aligned with regulatory expectations.
Using our Application
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
iVal
Supercharge validation with ValGenesis iVal™. AI-powered authoring, automated execution, live anomaly flags, and bulletproof traceability slash cycles by up to 80% and cut observations by 90%. From CQV to CSA, you’ll be audit-ready and market-ready faster than ever. iVal takes digital validation to the next level.
Learn More
iClean
Halve cleaning validation timelines and wipe out manual math with ValGenesis iClean™. Automated MACO calculations, ADE-aligned limits, 2D/3D equipment maps, and rule-driven workflows deliver digital, inspection-ready files across all sites. Standardize globally, flex locally, and gain real-time oversight - discover iClean today.
Learn More
iOps
Leave paper logbooks behind with ValGenesis iOps™. Mobile, QR-enabled forms capture every use, cleaning, and calibration event in real time; automated reviews, deviations, and alerts seal compliance gaps. Achieve 100% traceability, trim documentation labor by 70%, and connect ops to quality with iOps today.
Learn MoreReady to Turn Cleaning Validation Into an OEE Advantage?
Book a 15‑minute demo and see how ValGenesis recovers capacity, slashes changeover delays, and keeps every audit on cruise control.
Book a Demo