Method Qualification is used to determine method performance capabilities for parameters such as specificity, linearity, accuracy, and precision as required for an intended application. To generate data that can be statistically evaluated Vela's general approach is to perform the method by two operators each on three different days. In general, the following parameter recommended by ICH are investigated: Specificity, Precision (Repeatability/Intermediate Precision/Reproducibility), Accuracy, Linearity, Range, Limit of Detection and the Limit of Quantification.

In contrast to method validation, there are no predetermined method performance specifications; however, there may be minimal method performance capability requirements based on an intended application.