chapter  2
14 Pages

Analytical Instrument Qualification

In the most general sense, validation refers to a process that consists of at least four distinct components or steps: software, instruments, methods or procedures, and system suitability [1-8]. The system, the software, and the method must all be validated, and system suitability is used to keep the process in check. But while the overall process is called validation, some of the steps are also referred to by that same term, as well as others-for example, qualification and verification. Prior to undertaking the task of method validation, it is necessary to invest some time and energy up-front to ensure that the analytical system itself is validated, or qualified. Qualification is a subset of the validation process that verifies proper module and system performance prior to the instrument being placed on-line in a regulated environment.