The documented evidence that a procedure, process, or change has been fully evaluated before its implementation that it, which can provide a high degree of assurance of meeting pre-determined specifications and quality. First used by the Food and Drugs Administration in the US in the 1970s to improve the quality of pharmaceuticals, it is widely used in many industries and, in particular, the pharmaceutical and allied medical industries. It is used alongside other regulatory requirements such as Good Manufacturing Practice. Before the validation process begins, it is necessary to ensure that the system is properly qualified, which includes a design, installation, operational, performance, and component qualification. These define the function, operation, and specification of the equipment, process and product.