Appendix B – Package Configuration Test Specifications and Testing

The overall combination of Package Configuration Verification, Functional Testing and stress testing needs to be appropriate to:

• The GxP Criticality • Any prior experience with the package (that is documented) • The size and complexity of the overall system

The level and nature of verification/testing of each package will be unique to each system, should be well thought out by experienced personnel and documented and justified as part of the Test Strategy.