TABLE OF CONTENTS Showing that the components of the system have been correctly installed and work as the vendor expects is an important foundation in the overall CDS validation. Typically, third parties including IT and the vendor will carry out much of the work. However, the responsibility of the work planning, supervision and checking remains with the CDS validation team.
Clause 1327:
Before a system using a computer is brought into use, it should be thoroughly tested and confirmed as being capable of achieving the desired results.
Clause 13.431:
Test scripts should be developed, formally documented and used to demonstrate that the system has been installed, and is operating and performing satisfactorily. These test scripts should be related to the User Requirements Specifications and the Functional specifications for the system. This schedule of testing should be specifically aimed at demonstrating the validation of the system. 22 In software engineering terms satisfactory results obtained from the testing should confirm design validation.
Footnote 22 notes. The supplier/developer should draft test scripts according to the project quality plan to verify performance to the functional specifications. The scripts should stress test the structural integrity, critical algorithms and boundary value aspects of the integrated software. The test scripts related to the user requirements specification are the responsibility of the regulated users.
Section 5.2.6 End User Testing29:
Terminology regarding user site testing can be confusing. Terms such as beta...
