The Query Response System — A Database Which Captures Regulatory Questions/Responses

Abstract

The Query Response System (QRS) is a database designed to assist in the processing of regulatory inquiries received from regulatory agencies worldwide. The system uses the inquiry to identify the relevant questions, provides them to the appropriate scientist, and tracks receipt of the response which is then incorporated into QRS. The system provides for management approval of responses and generates letters to the Food and Drug Administration (FDA)/international registration manager for all approved or official responses. The advantages of the system include: 1. a fully electronic means to process and track regulatory questions and company responses, 2. a rapid searching mechanism to determine whether similar questions have been posed previously by other regulatory agencies, and 3. computer-generated reports designed to highlight repeated questions, thereby providing information that could be used in future submissions to possibly avert such questions. The system uses DOCUMENTUM, a UNIX-based document management tool that uses Oracle 7 as the back-end database. Oracle and DOCUMENTUM reside in a UNIX-based HP-9000 server and are accessed from networked personal computers.