Developing A Knowledge Interface for A Document Management System

The creation of a knowledge-preserving, value-added document indexing system is described. Rapidly increasing information requirements in a regulatory department brought about a need for a method of document retrieval structured according to the special needs of that profession. Identification of the specifics of information usage to achieve the tasks of a regulatory department led to the creation of a program in Lotus Notes. The program references documents according to their method of use in the department. These documents consist primarily of those issued by government regulatory bodies as part of the process of the regulation of medical products. It organizes and preserves the knowledge and context brought to a document by regulatory professionals. This system, termed the “Regulatory Workup,” delivers productivity improvements both in the quantity and quality of work accomplished in a regulatory affairs department.