Who is this for?
Quality Event Owner - completing the vigilance reporting assessment
How to do it
When the Quality Event type has vigilance reporting enabled, reportability must be captured before the record can move from Assessment to Review or Approval. When the type does not have it enabled, this section does not apply.
In the Assessment stage, locate Vigilance Reporting and select the edit pencil icon.
In Vigilance reporting, select one or more criteria that are met.
In Your assessment, enter the rationale that supports the selected criterion or explains why no criterion is met, then select Save.
The Vigilance Reporting criteria and assessment.
Vigilance reporting criteria
Criterion | Note |
Caused death, hospitalisation, or serious/life-threatening harm |
|
No harm occurred yet, but could reasonably require hospitalisation or cause life-threatening harm |
|
Unexpected event, not listed on current product labelling |
|
Led to, or may require, a recall or field action |
|
No criteria for reporting met | Selecting this option clears the individual criteria, and selecting an individual criterion clears this option. |
The saved criterion and assessment are recorded in the Audit Trail and Full History (see Workflow overview).
❗Once the reportability has been determined, submit the report outside of SimplerQMS to the relevant authorities.
❗SimplerQMS supports your reportability assessment, but the obligation to report (the recipient authority and the timeframe) is defined by the regulation that applies to your product and market. Follow your procedure and submit any required report to the relevant competent authority within the timeline that regulation sets.
💡Tip: Record a clear rationale even when “No criteria for reporting met” is selected. A documented negative assessment is itself evidence that reportability was considered, exactly what an auditor or inspector looks for.