ABSTRACT
Current legislation and regulatory guidance for the management and conduct of clinical trials is undergoing significant changes and the European and U.S. regulatory bodies are increasingly focusing greater attention on the compliance of the pharmaceutical industry to these regulations (1-3). Recent observations noted during both regulatory inspections and company vendor audits have indicated that one area of critical noncompliance, and a potential barrier to successful license applications, is that of the development, implementation, management, and controls applied to the use of computerized systems in the Good Clinical Practice (GCP) environment. Companies invest large amounts of time, resource, and finance into the process of developing, investigating, documenting, and registering new products, a process that can take upwards of 10 years to result in a successful launch to the marketplace. There are many stages during this process whereby the new product can fail, for example, not demonstrating adequate/beneficial therapeutic value, the presentation of adverse side effects, or not capable of being formulated into a delivery system suitable for mass production.
