MDSAP Chapter 4 — Adverse events and advisory notices

Chapter 4 has two tasks in the product data. Short does not mean optional if you sell where reporting rules apply.

Task 4.1 is notification of adverse events: a procedure, timelines for the jurisdictions you are in, records, and people trained to follow it. Task 4.2 is notification of advisory notices: how you start one, how you tell the authority, how you know it worked, and the file. The product's audit criteria say those things explicitly.

Timelines are jurisdiction-specific. This page does not print a number of days. Use the current FDA, Health Canada, EU vigilance, or other rule that applies to the event. Chapter 3 is where you decide the event might be reportable. Chapter 4 is where you show you reported, or that you recorded why you did not.

HAVGATE can hold the investigation as a CAPA and the procedure as a controlled document. It does not submit the report to an authority.

The working checklist is the full 4.1 and 4.2 set inside /mdsap-audit-checklist and in the product, not a PDF. Grades, when you assign them, are explained on the grading page. Confirm the current audit approach document before you treat a task title as the only criterion.