Method validation is the process by which it is established, through laboratory studies, that the performance characteristics of the method meet the requirements for its intended purpose. It is a part of the overall validation process that also includes software validation, instrument qualification, and system suitability. Although all analytical procedures or methods used in a regulated laboratory must be validated, this chart focuses specifically on liquid chromatography.
This wall chart provides a guide to analytical method validation and method development, including tips to consider for robustness, specificity, linearity and range, detection limit (DL or LOD), accuracy, quantitation limit (QL or LOQ), precision, system suitability, and data elements required for assay validation. The wall chart was provided as a supplement in LCGC North America magazine.