Computer systems used in the pharmaceutical industry and output from software used in regulatory submissions must be validated to assure proper performance. Companies must invest significant time and resources to manually write and perform the validation steps used in software execution, 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.
The Phoenix WinNonlin™ Validation Suite provides software validation in under 30 minutes with locked PDF reports containing links to results. Updated validation template documents are aligned with the latest regulatory guidance computer system validation such as ICH E6 Good Clinical Practice (GCP) R2.
Using automated execution of detailed test scripts, Validation Suite provides rapid and efficient validation testing of Phoenix WinNonlin software in under 30 minutes.
- Lower costs of validation projects by reducing time, resources and efforts needed to manually develop and run test scripts and plans
- Obtain robust reports with links to saved reference files, user output files, and difference files
- Ensure error-free and consistent testing of WinNonlin functionality
- Access the Validation Suite integrated into Phoenix without having to install a separate application
- Continue using other applications during execution of the Validation Suite
Detailed test scripts provide validation testing for WinNonlin general functionality, WinNonlin NCA engine, WinNonlin Classic engine, Phoenix modeling engine, and Toolbox functions. Phoenix 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 functionality
- Each test script automatically operates Phoenix WinNonlin to generate output and compares the output to verified results
- All results are saved in a Validation Report in Phoenix and immediately accessible for easy reference