ABSTRACT
In a 1990 OECD document, 1 John Frazier took one of the first major steps in developing an approach to validation. He defined validation as “the process by which the credibility of a candidate test is established for a specific purpose.” This definition is a first principle and is the basis for the modular approach to validation. Unfortunately, most previous validation studies have not incorporated this principle, with the exception of many industrial in-house studies. The modular approach fully incorporates this definition as a guiding principle.
