Validation Suite

Phoenix WinNonlin Validation Suite

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.

Phoenix WinNonlin Validation Suite 7.0 is a desktop application that provides objective evidence of Phoenix WinNonlin 7.0 functionality and streamlines the validation process through the use of automated tests accessed through a graphical user interface and validation document templates.

Streamline Validation Compliance Efforts

Using automatic execution of nearly 200 detailed test scripts, Validation Suite 7.0 provides rapid and efficient validation testing of Phoenix WinNonlin 7.0 software. Customized test plans and/or test scripts can also be used for further control over the testing process.

  • Obtain validation test results in days rather than weeks
  • 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 7.0 functionality

Comprehensive Functionality Testing

The detailed test scripts provide validation testing for WinNonlin 7.0 general functionality and installation qualification (IQ), models, table templates, toolbox functions and WinNonlin examples.

VS-ResultsA Graphical User Interface provides intuitive and simple viewing of results

View the status of all test scripts and obtain detailed step-by-step reports from specific individual test scripts effortlessly and easily.


Rapid Development of Validation Documentation

Documentation of activities are automatically generated in a Microsoft® Word Validation Run Report. Validation life cycle templates are provided to facilitate documentation:

  • Validation Plan
  • Phoenix WinNonlin Requirements Specification
  • Test Plan
  • Phoenix WinNonlin Traceability Matrix
  • Validation Summary Report
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