Phoenix WinNonlin Va.. - Pharsight Corporation

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(Optional) Test Plans 5. Users can create their own tests/scripts. Individual tests can be exported and edited (3 rd -party software required) and then run within the Val Suite. Any of the supplied test scripts can be exported, edited, and run allowing users the ultimate control over what they choose to validate. © Tripos, L.P. All Rights Reserved Slide 32
The Validation Suite Monitor The Validation Suite also contains a tool that can be optionally used. This tool (Validation Suite Monitor) 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. © Tripos, L.P. All Rights Reserved Slide 33
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 and 16: What is the Phoenix ® WinNonlin ®
Page 17 and 18: Document Templates provided with Ph
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: (Optional) Test Plans 1. Optionally
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

Phoenix WinNonlin Va.. - Pharsight Corporation

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