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.

Read more about this topic:  Change Control

Famous quotes containing the word environment:

    Modern man’s capacity for destruction is quixotic evidence of humanity’s capacity for reconstruction. The powerful technological agents we have unleashed against the environment include many of the agents we require for its reconstruction.
    George F. Will (b. 1941)