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.

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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.

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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.

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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.

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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.

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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 Sciences

Impact Metrics

100 %

digital documentation and traceability with automated audit trails 

50 %

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

Webinar

Digitization of Cleaning Validation Life Cycle

Digitization of Cleaning Validation Life ...

Cleaning Validation is a complex process. Over the years, the industry has ...

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Webinar

Digital Cleaning Validation Lifecycle

Digital Cleaning Validation Lifecycle

Cleaning validation is a complex process. Using manual, paper- or ...

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Webinar

Managing Cleaning Validation at an Operational Facility (Hosted by KENX)

Managing Cleaning Validation at an ...

Ensuring the validated state of a cleaning process in an operational ...

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Webinar

Common FDA 483 Cleaning Validation Observations and How to Avoid Them

Common FDA 483 Cleaning Validation ...

The pharmaceutical industry continues to face challenges in maintaining ...

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Webinar

ValGenesis Process Manager: The Future of Cleaning Validation

ValGenesis Process Manager: The Future of ...

The current pharma and biopharma business environment requires operational ...

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Webinar

Cleaning Validation Programmes: Establishing a Compliance-Led Framework

Cleaning Validation Programmes: Establishing ...

In the pharmaceutical industry, establishing an effective Cleaning ...

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Webinar

Digitize with Precision: Mastering Carry Over Calculations in Cleaning Validation

Digitize with Precision: Mastering Carry ...

Cleaning validation is often treated as an afterthought in pharmaceutical ...

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Webinar

Manufacturing Bottlenecks: Why Analog Cleaning Validation Programs Slow Down Your Entire Operation

Manufacturing Bottlenecks: Why Analog ...

Cleaning validation programs are complex to plan and deliver due to the ...

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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.