Scope of Computer Validation
The definition of validation above discusses production of evidence that a system will meet its specification. This definition does not refer to a computer application or a computer system but to a process. The main implications in this are that validation should cover all aspects of the process including the application, any hardware that the application uses, any interfaces to other systems, the users, training and documentation as well as the management of the system and the validation itself after the system is put into use. The PIC/S guideline (PIC/S 2004) defines this as a 'computer related system'. Much effort is expended within the industry upon validation activities, and several journals are dedicated to both the process and methodology around validation, and the science behind it (Smith 2001; Tracy & Nash 2002; Lucas 2003; Balogh & Corbin 2005).
Read more about this topic: Validation (drug Manufacture)
Famous quotes containing the words scope of, scope and/or computer:
“Every person is responsible for all the good within the scope of his abilities, and for no more, and none can tell whose sphere is the largest.”
—Gail Hamilton (1833–1896)
“Happy is that mother whose ability to help her children continues on from babyhood and manhood into maturity. Blessed is the son who need not leave his mother at the threshold of the world’s activities, but may always and everywhere have her blessing and her help. Thrice blessed are the son and the mother between whom there exists an association not only physical and affectional, but spiritual and intellectual, and broad and wise as is the scope of each being.”
—Lydia Hoyt Farmer (1842–1903)
“Family life is not a computer program that runs on its own; it needs continual input from everyone.”
—Neil Kurshan (20th century)