ABSTRACT
INTRODUCTION The FDA Glossary of Computerized System and Software Development Terminology, published by the agency in 1995, quotes an ANSI (American National Standards Institute) definition: a database is “a collection of interrelated data, often with controlled redundancy, organized according to a schema to serve one or more applications. The data are stored so that they can be used by different programs without concern for the data structure or organization. A common approach is used to add new data and to modify and retrieve existing data.” Perhaps a more prosaic definition, and one that is probably much more readily understood by a large majority of computer system users, quality assurance organizations, and regulatory authorities, is simply that a database is a compilation of related data that is needed to support some activity.
