Abstract
It is a reality that validation of computer systems in the pharmaceutical industry is required. Theories, concepts, and guidelines regarding computer system validation are abundant. But how many researchers have struggled with how to actually apply these principles to the real world situation, given the resources available, project timeline demands, and environmental constraints?
This paper discusses the practical application of system validation considerations during the design and implementation of a large comprehensive integrated system for handling clinical supplies in the clinical pharmacy area, covered by good manufacturing practices (GMP). This system's project team consisted mainly of outside consultants and was to be implemented in two countries, in a mainframe-type environment. The timeline was aggressive and the database technology, communications software, and hardware platform were relatively new to the organization for this type of system. Certain assumptions were made concerning tasks and roles in order to devote attention to the validation process right from the early stages of the development effort. Issues include: involvement of the sponsoring department and technical support staff, validation during the entire development process, role of the quality assurance unit, documentation, equipment, and the environment around the application. Discussion will not only cover what was done and what was successful, but also what was learned from the process — tasks and ideas that were adjusted or would be done differently the next time, with possible reasons why and suggested alternatives.
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