White Paper: Risk-Based Inspection Readiness: Reducing Headaches with Advanced Preparation

July 2019

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.

By downloading and reading the White Paper, you will learn how to:

• Implement a proactive, risk-based approach to inspection readiness within your organization
• Move toward a steady state of inspection readiness that is supported by confident, knowledgeable staff
• Leverage collective knowledge and industry-leading tools and practices
• Transition to a proactive state of inspection readiness with efficiency

Within the White Paper, you’ll find:

• An example of an active “Lessons Learned” process
• A table of the key components of a Quality Management System (QMS), along with descriptions
• A diagram of the appropriate tools for managing risk throughout the clinical trial lifecycle