Deviation Reports: Description

What is the purpose of the Description section in a deviation report?

• To provide a detailed analysis of the root causes

• To outline the immediate corrective actions taken

• To explain the background, expectations, and problem statement

• To summarize the final impact assessment

Who are the potential audience members for the Description section of a deviation report?

• Internal and external stakeholders

• FDA and customers only

• Internal QA only

• Regulatory authorities only

What is the main challenge when writing the Description section for external stakeholders?

• Explaining the root causes in technical terms

• Addressing the immediate corrective actions taken

• Providing a detailed historical review

• Making the information understandable and relatable to external stakeholders