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:
|
| Requirements Definition | Requirements Specification* Other names for the Requirements Specification include:
|
| 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:
Test Scripts** Other names for the Test Scripts include:
Run Report*** Other names for the Run Report include:
Traceability Document Another name for the Traceability Document is:
|
| Implementation | Validation Summary Report* Another name for the Validation Summary Report is:
|
* 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