Abstract
Compliance with FDA regulations governing adverse reaction reporting is most effectively achieved through the use of a sophisticated computer system. This paper describes the recently promulgated regulatory requirements and a computer system designed to help meet those requirements. Included are descriptions of the system design, its maintenance and its operation. Discussed are the 5 main databases (adverse reaction master file, master file audit trail, narrative text file, narrative text audit trail, submission history file), general adverse reaction dictionary, product specific adverse reaction dictionary for making 15 day alert decisions and the concept of adverse reaction frequency calculations. Also described are programs for data entry, data edit/update and for producing several standard reports, including laser printing of a completed FDA 1639 form.
Published Version
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