Regulatory Environment
In a Good Manufacturing Practice regulated industry, the topic is frequently encountered by its users. Various industrial guidances and commentaries are available for people to comprehend this concept. As a common practice, the activity is usually directed by one or more SOPs. From the information technology perspective for clinical trials, it has been guided by another USFDA document.
Read more about this topic: Change Control
Famous quotes containing the word environment:
“People between twenty and forty are not sympathetic. The child has the capacity to do but it can’t know. It only knows when it is no longer able to do—after forty. Between twenty and forty the will of the child to do gets stronger, more dangerous, but it has not begun to learn to know yet. Since his capacity to do is forced into channels of evil through environment and pressures, man is strong before he is moral. The world’s anguish is caused by people between twenty and forty.”
—William Faulkner (1897–1962)