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Why Phoenix® Connect Validation Suite™?   

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

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

The Phoenix Connect 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
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