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:

    Maturity involves being honest and true to oneself, making decisions based on a conscious internal process, assuming responsibility for one’s decisions, having healthy relationships with others and developing one’s own true gifts. It involves thinking about one’s environment and deciding what one will and won’t accept.
    Mary Pipher (20th century)