Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
CHAPTER 21: Designing the User Acceptance Test Suite
Published:23 Nov 2016
This is the first of three linked chapters covering the user acceptance testing (UAT) or Performance Qualification (PQ) phase of a CDS validation. In this chapter we look at how to design and document the overall user acceptance test suite in a UAT / PQ test plan that includes traceability to the requirements from the URS. This phase of testing is undertaken by the users and must be based upon the way that the system will be 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.