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The Toxicology Archives. II. An Interactive Database Oriented System

The Interactive Toxicology Archive System of Hoechst-Roussel Pharmaceuticals Inc. was designed to provide and ensure an expedient system for producing archival documentation required by Food and Drug Administration (FDA) Good Laboratory Practice Regulations for Nonclinical Laboratory Studies (Subpart J, Section 58.190).’ These regulations require that “material retained or referred to in the archives shall be indexed by test article, date of study, test system and nature of study.” These archive indices have been computerized and arc part of the Toxicology Experiment Information Database, operating on an IBM 3033 (System 370) with data entry and retrieval utilizing Infodata’s INQUIRE@ Database Management System. The database was designed to interact through data processing with other key functions in the Department of Drug Safety, principally Toxicology Management and the Quality Assurance unit, for the purpose of providing one source of pertinent administrative information necessary for the management and monitoring of studies.