Developing A Knowledge Interface for A Document Management System
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Drug Information Journal. Vol. 33, pp. 95-99. 1999 F’rinted in the USA. All rights reserved.
DEVELOPING A KNOWLEDGE INTERFACE FOR A DOCUMENT MANAGEMENT SYSTEM STEVENAGORATUS, DA Regulatory Coordinator, ConvaTec, A Bristol-Myers Squibb Company, Skillman, New Jersey
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 “RegulatoryWorkup,”deliversproductivity improvements both in the quantity and quality of work accomplished in a regulatory affairs department. Key Words: Knowledge management; Index; Document management; Productivity; Regulatory affairs
THIS ARTICLE DESCRIBES how a regulatory department encountered and met the dynamic change and rapid decision making that characterize the modem medical products business arena. Information-dependent tasks must be completed in a manner and time period profitable to the company. Thus, information handling must improve as business needs dictate. This upgrading takes two major directions:
quisition, distribution, storage, and retrieval. Rapidly increasing information requirements caused by implementation of European Community law in 1992; the Safe Medical Devices Act of 1990 (SMDA); and the 1992 Device Amendments overloaded existing acquisition, distribution, storage, and retreival systems, threatening productivity. At one company, subsequent implementation of a solution developed through total quality management procedures solved this problem (1). Large numbers of documents could quickly and easily be acquired, stored, and retrieved, using traditional alphabetical, chronological, or broad subject area indexes. Readily accessible and retrievable information produced a problem of its own, however: as business requirements continued to grow, it was not always easy to identify a particular document needed. There was room for productivity improvement, as staffers returned repeatedly to the system as they found
1. Document acquisition, distribution, storage, and retrieval, and 2. Arrangement of those documents to contribute value to business decisions. In the mid-1990s medical product company regulatory departments faced a potential information quagmire in document acReprint address: Steven Agoratus, ConvaTec, Mailstop C1-10.2, P.O. Box 5254. Princeton. NJ 08543-5254.
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