Monitor the performance of your manufacturing processes and generate the Annual Product Review / Product Quality Review (APR / PQR) reports in accordance with ICH Q7, ICH Q10 and European GMP.

Fill in the contextual information about your study and its purpose.

Import one or more parameters with the input assistant or by simply copying / pasting from your usual spreadsheet.

Load an example of a dataset directly into the application and quickly get a preview of the results.

Visualize the evolution of your process over the study period.

Calculate / review control limits to prevent and correct drift and ensure product quality.

Submit the algorithm.

Get the ability indices adapted to the characteristics of your parameters.

Evaluate the performance of your process to ensure the quality of your products in fine.

Publish the full study report in compliance with the regulatory requirements of the Product Quality Review and built according to eCTD guidelines to facilitate the sharing of results.

The application is fully validated and meets 21-CFR-part 11 recommendations.

The application is accessible without installation and at any time on our secure platform.