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:
“The poorest children in a community now find the beneficent kindergarten open to them from the age of two-and-a-half to six years. Too young heretofore to be eligible to any public school, they have acquired in their babyhood the vicious tendencies of their own depraved neighborhoods; and to their environment at that tender age had been due the loss of decency and self-respect that no after example of education has been able to restore to them.”
—Virginia Thrall Smith (1836–1903)