Abstract :
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)
Keywords :
formal verification; health care; security of data; Food and Drug Administration-regulated validation; computer system validation; current good manufacturing practices; data validation; electronic records; electronic signatures; good clinical practices; good laboratory practices; healthcare organizations; medical research; pharmaceutical research; regulations; system validation; Biomedical equipment; Hardware; Instruments; Laboratories; Manufacturing; Performance evaluation; Qualifications; Software systems; System testing; Writing; Clinical Medicine; Device Approval; Documentation; Equipment and Supplies; Government Regulation; Guideline Adherence; Guidelines as Topic; Software Validation; United States; United States Food and Drug Administration;
