The Document Request

Handle inspector document requests and navigate common inspection scenarios

Role: Quality Assurance Lead (PV)

Context: Day 2 of an FDA inspection. The inspector has reviewed your PADER submissions and now wants to examine your internal processes more closely.

Task: Respond appropriately to each document request and situation.

Step 1 of 3

The SOP Request

interview

Inspector: 'I'd like to see your current SOP for adverse event intake and processing. I'd also like to see the previous two versions and the change history showing what was modified and why.'

What's the best way to handle this request?