ABSTRACT
The concept of validation was developed in the 1970s and
is widely credited to Ted Byers who was then Associate
Director of Compliance at the U.S. FDA. The concept was
focused on:
This concept continues to be followed, with some
modifications, by the various authorities regulating GMP
around the world. This definition also has been adopted
for the validation business, manufacturing and labora-
tory computer systems. The need to validate computer
systems formally began in 1979 when the U.S.A. intro-
duced GMP regulatory legislation which specifically
referred to automation equipment. GMP is enforced by
national regulatory authorities who can prevent the sale
of a product in their respective country if they consider its
manufacture not to be GMP compliant. Validation for
GMP is a license-to-operate issue.
