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:
“If the Revolution has the right to destroy bridges and art monuments whenever necessary, it will stop still less from laying its hand on any tendency in art which, no matter how great its achievement in form, threatens to disintegrate the revolutionary environment or to arouse the internal forces of the Revolution, that is, the proletariat, the peasantry and the intelligentsia, to a hostile opposition to one another. Our standard is, clearly, political, imperative and intolerant.”
—Leon Trotsky (1879–1940)