Phoenix WinNonlin Va.. - Pharsight Corporation

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Key Benefits ● ● ● ● ● ● Ensures that your Phoenix ® WinNonlin ® is functioning as intended Saves time and reduces errors with automated testing Reduces labor for validation personnel as test scripts, input datasets, reference output, and validation life cycle document templates are all included Allows for customized test plans and/or test scripts giving testing personnel full control of the testing process Upgrading is free for all customers who have paid for their current maintenance agreements • Easier re-validation when you upgrade to new versions of Phoenix WinNonlin Monitors validation status in real-time and notifies the user if any “material” changes have occurred (optional) © Tripos, L.P. All Rights Reserved Slide 16
Document Templates provided with Phoenix ® WinNonlin ® Validation Suite Four Microsoft Word templates are included with Phoenix ® WinNonlin ® Validation Suite as a starting point for common validation life cycle documents. These include: • Validation Plan template (PHX WNL Val Suite 2.0 Validation Plan Template.doc) • Phoenix ® WinNonlin ® 6.1 Requirements Specification template (Phoenix WinNonlin 6.1 Requirements Specification template.doc) • Test Plan template (PHX WNL Val Suite 2.0 Test Plan Template.doc) • Validation Summary Report template (PHX WNL Val Suite 2.0 Validation Summary Report Template.doc) These documents are located at: C:\Program Files\Pharsight\Validation Suite 2.0\WNL Package\Documentation © Tripos, L.P. All Rights Reserved Slide 17
Page 1 and 2: Computer System Validation Discussi
Page 3 and 4: Why Validate? - continued Guidance
Page 5 and 6: Validation Terminology - General Pr
Page 7 and 8: Validation Terminology - FDA Office
Page 9 and 10: Computer System Validation - Genera
Page 11 and 12: Validation Life Cycle Activities A
Page 13 and 14: Walk Through Phoenix ® WinNonlin
Page 15: What is the Phoenix ® WinNonlin ®
Page 19 and 20: How It Works 2. If first time using
Page 21 and 22: How It Works 6. You can also set fi
Page 23 and 24: How It Works 9. When a Test package
Page 25 and 26: The Results Panel © Tripos, L.P. A
Page 27 and 28: The Show Log Panels © Tripos, L.P.
Page 29 and 30: The Summary Results Panel © Tripos
Page 31 and 32: (Optional) Test Plans 1. Optionally
Page 33 and 34: The Validation Suite Monitor The Va
Page 35 and 36: The Validation Suite Monitor The Va
Page 37 and 38: The Validation Suite Monitor Log ©
Page 39 and 40: Contacts & Follow-Up: Thank you! No

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