Change Control - Regulatory Environment

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.

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Famous quotes containing the word environment:

    In a land which is fully settled, most men must accept their local environment or try to change it by political means; only the exceptionally gifted or adventurous can leave to seek his fortune elsewhere. In America, on the other hand, to move on and make a fresh start somewhere else is still the normal reaction to dissatisfaction and failure.
    —W.H. (Wystan Hugh)