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Can I derive new variables from process parameters, material attributes, or quality attributes across unit operations?

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.

How does the platform support CPV programs?

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.

What makes iCPV different from traditional solutions?

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.

Is the platform suitable for both pharmaceutical and biopharmaceutical manufacturing?

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.