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:

    A positive learning climate in a school for young children is a composite of many things. It is an attitude that respects children. It is a place where children receive guidance and encouragement from the responsible adults around them. It is an environment where children can experiment and try out new ideas without fear of failure. It is an atmosphere that builds children’s self-confidence so they dare to take risks. It is an environment that nurtures a love of learning.
    Carol B. Hillman (20th century)