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:
“For it is not the bare words but the scope of the writer that gives the true light, by which any writing is to be interpreted; and they that insist upon single texts, without considering the main design, can derive no thing from them clearly.”
—Thomas Hobbes (1579–1688)
“In the works of man, everything is as poor as its author; vision is confined, means are limited, scope is restricted, movements are labored, and results are humdrum.”
—Joseph De Maistre (1753–1821)
“What, then, is the basic difference between today’s computer and an intelligent being? It is that the computer can be made to see but not to perceive. What matters here is not that the computer is without consciousness but that thus far it is incapable of the spontaneous grasp of pattern—a capacity essential to perception and intelligence.”
—Rudolf Arnheim (b. 1904)