ABSTRACT
Current legislation and regulatory guidance for the management and conduct of clinical trials are 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
Functional Subgroup Data Capture Data Processing Production Control Record Management
the use of computerized systems in the GCP environment. Companies invest large amounts of time, resources, and finance into the process of developing, investigating, documenting, and registering new products-a process that can take upward 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, by not demonstrating adequate/beneficial therapeutic value, by the presentation of adverse side effects, or by
not being capable of being formulated into a delivery system suitable for mass production.
