Proactive Monitoring.
Real-Time Insights.
Quality Assured.

ValGenesis iCPV™ transforms continued process verification through automated data analysis for early issue detection and consistent product quality across sites and batches.

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Empowering Life Sciences

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

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Discover How iCPV works as Part of the ValGenesis Process Lifecycle Suite

iCPV centralizes and automates continued process verification using multivariate statistical tools, control charts within a statistical process control (SPC) framework, and flexible, guided workflows.

From monitoring CPPs and CQAs to triggering alerts on process drift, iCPV ensures quality decisions are made in real time through multivariate and predictive data analytics in the pharmaceutical industry. Teams follow guided workflows to design, execute, and maintain CPV programs with confidence, supported by custom plots, automated updates, and standardized, automated reporting.

Integrated with LIMS, MES, SAP, and manufacturing systems, iCPV turns fragmented process data into actionable insights—delivering intelligent, compliant pharmaceutical manufacturing software for modern operations.

Overview

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See issues before they happen

Detect trends early with multivariate analytics and real-time alerts to prevent deviations.

Streamline CPV from end to end

Automate report generation and minimize manual effort with guided, validated workflows.

Ensure continuous quality and compliance

Monitor CPPs and CQAs at scale, maintain audit readiness, and support regulatory assurance.

Resources

Industry Insight

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Risk and Data as Knowledge Enablers: A ...

One of the goals of industry 4.0: to have an integrated end-to-end and ...

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Industry Insight

A Roadmap for PAT Implementation

A Roadmap for PAT Implementation

Process Analytical Technology (PAT) is a system for designing, analyzing, ...

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Industry Insight

MSPC: A Window With Endless Views

MSPC: A Window With Endless Views

MSPC can support a continuous manufacturing process monitoring and ...

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Industry Insight

Digital CPV for Continuous Manufacturing

Digital CPV for Continuous Manufacturing

Automated data collection will streamline the identification of deviations ...

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Webinar

The Path to Real-time CPV: An Implementation Case Study

The Path to Real-time CPV: An Implementation ...

Over a decade ago, the FDA unleashed the powerful CPV concept through its ...

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Industry Insight

Comparability for Post-Approval Changes

Comparability for Post-Approval Changes

In this Industry Insight we take a fresh look into comparability for ...

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Webinar

Data-Driven Risk Management: a Practical Approach to Minimize Subjectivity

Data-Driven Risk Management: a Practical ...

In this webinar, we will explain how ICH Q9 (R1) introduced the need to ...

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Webinar

Join the Digital CPV Revolution With Process Insight!

Join the Digital CPV Revolution With Process ...

Are you ready to take your Continued Process Verification (CPV) to the ...

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Frequently Asked Questions

Yes. The suite allows the creation of computed variables and composite metrics using data from different unit operations. These variables can be used in monitoring CPV programs or as satellite variables for additional analytics. For this computation the system supports different mathematical fit functions and statistical metrics.

The platform includes a guided CPV workflow that walks users through the full lifecycle of a CPV program, from selecting the variables, aligned with QbD principles, to set ongoing process monitoring. This ensures consistency, traceability, and compliance with regulatory expectations.

Unlike conventional tools, our platform goes beyond simple data visualization. It enables programmatic setup of CPV activities, leverages reference definitions supported by multivariate data analysis (MVDA), and automates monitoring and reporting based on those definitions. The result is a proactive, structured approach to quality assurance.

Yes. It is designed to accommodate the complexity and variability of biopharmaceutical processes as well as the scale and volume of traditional pharmaceutical manufacturing. Features like MVDA and batch comparability make it especially effective in high-variability environments.