FDA-regulated validation in clinical and nonclinical environments (Regulatory Affairs)

The Food and Drug Administration (FDA) governs the activities of medical and pharmaceutical research and healthcare organizations through regulations including, but not limited to, good laboratory practices (GLPs), current good manufacturing practices (CGMPs), good clinical practices (GCPs), and electronic records and electronic signatures (ERESs). These good practices and ERESs cite various requirements that comprise "validation". These regulations cover both the clinical and nonclinical environments. The FDA requires many different types of validation, such as methods and data validations. This article presents an overview of two validation types: a system validation and computer system validation (CSV)