ABSTRACT
Despite the fact that the Food and Drug Administration (FDA) has required validation of computer systems used for electronic trial data handling in clinical trials since 1996 (see International Conference on Harmonization [ICH] Good Clinical Practice (GCP) section 5.5.3), there is still confusion as to what validation is and when it is required. There are entire courses, seminars, and books devoted to this topic, as well as FDA guidance documents. Because it is such a large topic, this chapter will only present a very high-level introduction to the concepts of, and approaches to validation. Since most data managers will be involved in validation of vendor products, the focus will be on validating purchased systems rather than validation for systems and large software applications developed in house.
