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The Avoca Group

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Risk-Based Inspection Readiness: Reducing Headaches with Advanced Preparation

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.


Risk-Based Inspection Readiness: Reducing Headaches with Advanced Preparation
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