Validation Suite

Phoenix WinNonlin Validation Suite 8.0

As required by US FDA’s 21 CFR Part 11, International Conference on Harmonization of Technical Requirements (ICH), EudraLex Annex 11, and other regulatory agency guidance documents, computer systems used in the pharmaceutical industry and output from software used in regulatory submissions must be validated to assure proper performance. This necessitates companies to invest significant time and resources to manually write and perform the validation steps used in software execution.

Validation Made Fast and Easy

The Phoenix® WinNonlin® Validation Suite 8.0 is integrated into Phoenix 8.0 and provides objective evidence of Phoenix WinNonlin 8.0 functionality. It streamlines the validation process through automated tests accessed through a graphical user interface and validation document templates.

Streamline Validation Compliance Efforts

Using automatic execution of 82 detailed test scripts, Validation Suite 8.0 provides rapid and efficient validation testing of Phoenix WinNonlin 8.0 software.

  • Access the Validation Suite within Phoenix 8.0 without having to install a separate application
  • Obtain Phoenix WinNonlin validation test results in under 30 minutes rather than days
  • Continue using other applications during execution of the Validation Suite
  • Lower costs of validation projects by reducing time, resources and efforts needed to manually develop and run test scripts and plans
  • Ensure error-free and consistent testing of WinNonlin 8.0 functionality

Leverage Comprehensive Functionality Testing and Obtain Validation Documentation

Detailed test scripts provide validation testing for WinNonlin 8.0 general functionality, WinNonlin NCA engine, WinNonlin Classic engine, Phoenix modeling engine, and Toolbox functions. Phoenix 8.0 also provides documentation of activities by automatically generating a Validation Report.

  • Detailed test scripts are automatically executed, ensuring rapid, consistent, and error-free testing of WinNonlin 8.0 functionality
  • Each test script automatically operates Phoenix WinNonlin 8.0 to generate output and compares the output to verified results
  • All results are saved in a Microsoft® Word Validation Report in Phoenix 8.0 and immediately accessible for easy reference

Ready for a More Efficient Validation Process?

Contact us to learn more about the new features of Phoenix Validation Suite 8.0.

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