So often, inspections are a major source of stress in the clinical trial
environment. This is especially true when processes involved in preparing for an
inspection are reactive. But, it doesn’t have to be that way. Using industry-leading
practices and resources enables a proactive approach to mitigate—or even
eliminate—the pain points associated with preparing for inspections.
The term “risk-based approach” encompasses all activities related to risk-based
quality management (RBQM). RBQM is defined as a “systematic process put in
place to identify, assess, control, communicate, and review the risks associated
with the clinical trial during its lifecycle.
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