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Phoenix Validation Suite
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Phoenix® NLME™ Validation Suite™ 
Quickly and Easily Validate Phoenix® NLME™!
Navigating the validation of software systems for 21 CFR Part 11 compliance can be costly, time consuming, and labor intensive. Pharsight's Validation Suite reduces these burdens by automating many of the tasks of validation.
The Phoenix NLME Validation Suite validates the key functionality of Phoenix NLME using automated test scripts, accessed through a graphical user interface, to streamline validation testing.
Key Benefits
The Validation Suite efficiently and effectively provides documentation of your on-site testing activities by operating Phoenix NLME automatically in order to generate output, compare that output to standard known results, and report the results in a Microsoft Word Run Report. The Validation Suite also provides a Computational Models Validation Report which summarizes the testing performed by Pharsight to verify the computational engines within Phoenix NLME.
How it Works
Pharsight has distilled its vast multifunctional knowledge about Phoenix NLME and packaged it in the Validation Suite.
The Validation Suite also includes the following template documents, for optional use as starting points for your validation life cycle documentation:
- Validation Plan template
- Phoenix NLME Requirements Specification template
- Traceability document between requirements and validation test scripts
- Test Plan template
- Validation Summary Report template.
The Validation Suite includes dozens of automated test scripts, which you can edit if desired. You can also create your own test scripts. Both the edited scripts and your developed test scripts can be automatically executed within the Validation Suite. Note that extensively editing and creating test scripts requires the purchase of 3rd-party software.
The Validation Suite also contains an optional application that constantly monitors the state of validated computer systems to determine if any element of the computer's configuration has changed since it was validated. If a material change (as defined by the user) has taken place, a flag in the computer's system tray will alert the user.