ABSTRACT
Validation is the process of determining the suitability of a measurement system for providing useful analytical data. While the term is used most frequently in discussing methodology, it applies to all aspects of the system and especially to samples, their measurement, and the actual data output. Validation of methodology is a value judgment in which the performance parameters of the method are compared with the requirements for the analytical data. Several approaches may be used to validate methodology. When reference samples are available that are similar in all respects to the test samples, the process is very simple. Data validation is the process by which data are filtered and accepted or rejected based on a set of criteria. It is the final step that should be taken before release of data. The requirement is the documented validity of the sample and the measurement process used.
