Standard Operating Procedures for Computer Systems Validation

Abstract

At the Pharmaceutical Manufacturers Association (PMA) Seminar on Computer Systems Validation held in January 1984, the Food and Drug Administration (FDA) emphasized that documentation of computer system validation is expected not only in the manufacturing area but also in the research area. Such documentation must include a Standard Operating Procedure (SOP) to describe and define the manner in which scientific computer systems are validated and how that validation is documented. During the year since the PMA workshop, the members of the scientific computing community at McNeil Pharmaceutical have attempted to organize their response to the FDA's requirement for computer systems validation. The result is a comprehensive SOP which was described at the Drug Information Association (DIA) workshop in January, 1985.