TABLE OF CONTENTS The Performance Qualification phase of the overall validation of the system can be considered as the acceptance testing or end-user testing. This is undertaken by the users and must be based upon the way that the system is used in a particular laboratory. Therefore, a CDS cannot be considered validated simply because another laboratory has validated the same software application. The operations of two laboratories may differ markedly even within the same organisation.
The functions to be tested in the PQ must be based on the requirements defined in the URS and with the numbering of individual requirements can be traced back to the system requirements. The main issue is how can users test their CDS software?
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.
Section 4.229:
Software testing is a necessary activity. However, in most cases software testing by itself is not sufficient to establish confidence that the software is fit for its intended use.
Note the use of the bold text by the FDA in the original document.
Section 5.2.6 end-user testing:
User site testing should follow a pre-defined written plan with a formal summary of testing and a record of formal acceptance. Documented evidence of all testing procedures, test input data, and test results should be retained. There should be...
