Validation

Validation of an analytical method is the documented process that establishes by laboratory studies that the performance characteristics of the method meet the requirements for the intended analytical applications. In contrast to method qualification, acceptance criteria are established before validation begins; validation should not be a discovery or optimization study. Specifications must be met by every validation trial run for the validation study to pass. In contrast to method qualification, method validation studies are more rigid method assessment exercises including parameters like robustness/ruggedness and sample stability.