Development of Systematic Data Access and Integrity Features for Pharmaceutical Computer Applications

Abstract

A major concern in the development and implementation of computerized data systems in the pharmaceutical environment is to ensure data security and integrity. To provide these features the system must regulate user and data access and also maintain complete audit trails of data modifications. These are important features if the system is going to mimic and/or remain in compliance with current regulatory procedures. In response to these needs there has been much discussion regarding system security, database security, user privileges, and system audit trails. This article focuses on the concepts and methods that may be used to provide both system and data security, as well as maintain the required access to the system's data. Methods include examples of security and audit trail implementations from currently existing applications in the research and development environment.