Already in the 1983 many technical documents, books, articles, spoke in America of the validation of the it systems. One of the first books that traced the lines guides for the druggist industry (Bluebook by Rick Gorwood & Paul Motise) emphasized the validation and the quality of the software.
Much road has been made from then and the lines guide for the druggist industry are evolute and have interested also the technical part of the development of this product. They have become true and own laws (in USA) for the development of the it systems in these processes, and lines guide in a generalized manner for the development of it systems of industrial automation.
The Gamp (Good automated manufactoring practice) is the general guide where is contained these norms, today to its version 4, fruit of the effort of a normative agency as the FDA (Food and Drug American Administration) and of its collaborators. Today the Gamp has acquired international valence and even if ago reference to restricted productions controlled from the FDA, more and more frequently comes used also in other productions