Why you never really validate your analytical method unless you use the total error approach (part I: concept)

Consistent and efficient use of any analytical procedure requires the knowledge of its reliability prior to its use. It is therefore necessary for each laboratory to validate their analytical methods. Validation is not only required by regulatory authorities [ICH, FDA, GxP] or in order to access accreditation [ISO 17025] but is also the essential step prior to the routine use of the method. The role of analytical method validation is to provide confidence in laboratory generated results that will later be used to make critical decisions.