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Why Phoenix WinNonlin® Validation Suite™?   

A typical validation life cycle would include the following activities, with associated deliverables.  

Where does the Validation Suite for Phoenix WinNonlin® fit in the overall validation process?           At almost every stage!

The Phoenix WinNonlin Validation Suite provides a solution to the Highlighted deliverables.

Activities Deliverables
Validation Planning

Validation Plan*

Other names for the Validation Plan include:

  • Validation Master Plan
  • Project Plan
  • System Plan
Requirements Definition

Requirements Specification*

Other names for the Requirements Specification include:

  • User Requirements Specification
  • Functional Requirements Specification
  • System Requirements Specification
Design Definition Typically not applicable for Phoenix WinNonlin, Phoenix Connect, or Phoenix NLME
Configuration/Construction of Custom Code Typically not applicable for Phoenix WinNonlin, Phoenix Connect, or Phoenix NLME

Testing or User Site Testing

Also know as: System Testing, Functional Testing, Site Validation, Installation Qualification, Operational Qualification, Performance Qualification, Installation Testing, Installation Verification, User Acceptance testing, Site Acceptance Testing, Validation Testing, among other names.

Test Plan*

Other names for the Test Plan include:

  • Installation Qualification (IQ) Protocol
  • Operational Qualification (OQ) Protocol
  • Performance Qualification (PQ) Protocol
  • Validation Protocol

Test Scripts**

Other names for the Test Scripts include:

  • Test Cases

Run Report***

Other names for the Run Report include:

  • Testing Summary Report
  • Installation Qualification Report
  • Operational Qualification Report
  • Performance Qualification Report 

Traceability Document

Another name for the Traceability Document is:

  • Traceability Matrix
  • Although the current version of the Validation Suite does not contain a Traceability document, one can easily be created using documentation found in the provided User's Guide and tailored to specific needs.
Implementation

Validation Summary Report*

Another name for the Validation Summary Report is:

  • System Acceptance Report

* A template for this is included in the Validation Suite

** Test scripts that are included in and executed by the Validation Suite

*** Produced by the Validation Suite after execution of test scripts