Risk-based.
Justified Limits.
Digital Cleaning Validation.

ValGenesis iClean™ streamlines cleaning validation with global standardization, automated oversight, and scientific justification—ensuring audit readiness across all sites.

Discover AI Validation

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Impact Metrics

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digital documentation and traceability with automated audit trails 

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faster cleaning validation cycle time through automation 

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Discover How iClean Works as Part of Our Validation Lifecycle Suite

iClean digitalizes the entire cleaning validation lifecycle—from risk-based planning and MACO determination to execution and ongoing requalification. It automates calculations, integrates ADE/NOAEL-based scientific data, and uses 2D/3D equipment mapping to guide the sampling strategy.

With business-rule-driven decision trees, built-in residual limit enforcement, and a centralized method and agent repository, iClean helps teams reduce manual work, eliminate errors, and maintain global consistency. Its change control and requalification workflows ensure sustained compliance—even as processes evolve. 

 

Overview

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Accelerate compliance, reduce risk

Automate MACO calculations, validation cycles, and documentation for faster, inspection-ready delivery. 

Standardize globally, flex locally

Centralize cleaning strategies while adapting validation protocols to site-specific and equipment-specific requirements.

Gain real-time oversight

Visualize status, risks, and readiness across sites through built-in analytics and intelligent dashboards.

Resources

Industry Insight

The Future of Cleaning Validation

Modernize cleaning validation with digital CPV, better documentation, and early deviation ...

Industry Insight

Unlocking Operational Capacity with Fully Digitalized Cleaning Validation

Cut cleaning-validation downtime and audit stress with a fully digital approach. Read the Industry ...

Webinars

Digital Cleaning Validation Lifecycle

Cleaning validation is a complex process. Using manual, paper- or Excel-based processes creates a ...

Cleaning Validation Programmes: Establishing a Compliance-Led Framework

In the pharmaceutical industry, establishing an effective Cleaning Validation (CV) program is ...

Common FDA 483 Cleaning Validation Observations and How to Avoid Them

The pharmaceutical industry continues to face challenges in maintaining proper cleaning regimens ...

Videos

How Digitalizing Cleaning Validation Leads to Shorter Timelines and Fewer Errors

Speed up cleaning validation with a digital, risk‑based workflow. See how teams cut cycle times by ...

ValGenesis iClean™: Risk-based. Justified Limits. Digital Cleaning Validation.

Modernize cleaning validation with risk-based workflows, justified limits, and centralized ...

3 Ways Old-School Cleaning Validation Delays Your Production Schedule

Stop cleaning-validation changeover delays. Learn the 3 old-school blockers and how digital, ...

Frequently Asked Questions

Do you need help with something or have questions about any features?

Yes. iClean leverages digitized 2D and 3D models of equipment, applying risk-based logic to each equipment part. This enables users to identify and insert appropriate sampling locations on the models, which are then automatically embedded into protocols—streamlining compliance and traceability.

Yes. iClean calculates maximum allowable carryover (MACO) based on HBELs such as ADE/PDE or other criteria defined by the user. It considers shared surface areas, batch sizes, and additional attributes. The system can calculate these values down to the material level and maps them to specific equipment, enabling accurate residue determination.

Yes. iClean supports worst-case product evaluation based on ADE/PDE potency, solubility, toxicity, and difficulty to clean. This ensures a conservative, risk-based approach to cleaning validation.

Yes. All cleaning procedures, equipment-specific parameters (e.g., temperature, time, flow), and validation data are stored and version-controlled within iClean. Users can define, monitor, and manage changes with full audit trail and compliance status visibility.

Ready for Smarter Cleaning Validation?

Simplify cleaning validation. Ensure audit readiness. Get started with ValGenesis iClean™.