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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Your Manufacturing Will Be in Good Company

Join the life sciences leaders using the ValGenesis Process Lifecycle Suite to remove barriers to innovation and accelerate delivery - by making process lifecycle execution consistent, connected, and efficient.

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corden pharma

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Customer Testimonials

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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

Read the Case Study

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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

Download Product Sheet

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

Automated Validation and Centralized Data: The Future of CPV Compliance

Automated Validation and Centralized Data: The Future of CPV Compliance

Shift CPV from manual reports to real-time control with automated ...

Industry Insight

Smarter by the Second: How Real-Time Monitoring is Redefining Pharma and Biopharma Manufacturing

Smarter by the Second: How Real-Time Monitoring is Redefining Pharma and Biopharma Manufacturing

Catch process drift early with real-time monitoring, support PAT, and ...

Industry Insight

The Path to Digital CPV

The Path to Digital CPV

Start digital CPV with real-time trending, alarms, and compliant records. ...

Webinar

Webinar

How ValGenesis Process Lifecycle Suite Frees Up Teams to Focus on Quality, Not Data Entry

How ValGenesis Process Lifecycle Suite Frees Up Teams to Focus on Quality, Not Data Entry

Continued Process Verification (CPV) was introduced with the FDA’s 2011 ...

Webinar

Digital CPV: Important Step in Your Pharma 4.0 Journey

Digital CPV: Important Step in Your Pharma 4.0 Journey

Digitization is an objective for organizations that want to be compliant, ...

Webinar

Digital Transformation of Your Site: A Step-By-Step Program

Digital Transformation of Your Site: A Step-By-Step Program

Digitalization of companies operating within the life-science landscape ...

Webinar

Avoid CPV Failures: Proven Ways to Catch Deviations Early

Avoid CPV Failures: Proven Ways to Catch Deviations Early

In its 2011 Guidance for Industry: Process Validation—General Principles ...

Webinar

Reducing Errors and Gaining Efficiency in Your CPV Program

Reducing Errors and Gaining Efficiency in Your CPV Program

The concept of continued process verification (CPV) was first introduced a ...

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.

Ready to Automate
Real-time Process Monitoring?

Book a demo to discover how a fully digital CPV can impact your processes, your manufacturing, and your product quality.