How International Quality Assurance Audits Can Contribute to Quality Management

Abstract

Today's harried pharmaceutical managers are trying to meet ever increasing government requirements and market demands. Simultaneously, they are pressed to decrease staff resources, costs, and time to market. “Quality” is often trumpeted as the magic solution but how can this be accomplished? If an international clinical quality assurance group has developed a mixed palette of individual audits (clinical trial center, case report form versus database, and clinical research report) as well as system (process) audits (monitoring department, contract research organizations, central laboratories, etc.), it can contribute to both the “Plan” and “Check” phases of quality management to enhance functional line management's improvement efforts. Auditors should have extensive previous international research experience; a mature, positive personality with sensitivity and good communication skills; and a variety of professional backgrounds and languages.