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Deviation Reports: Description

Authored by Kelly Zepp

English

Professional Development

Used 2+ times

Deviation Reports: Description
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3 questions

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1.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

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

2.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

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

3.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

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

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