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:
“Autonomy means women defining themselves and the values by which they will live, and beginning to think of institutional arrangements which will order their environment in line with their needs.... Autonomy means moving out from a world in which one is born to marginality, to a past without meaning, and a future determined by others—into a world in which one acts and chooses, aware of a meaningful past and free to shape one’s future.”
—Gerda Lerner (b. 1920)