Definition

A documented plan describing the procedures, responsibilities, and timelines for signal detection, validation, evaluation, and action.

Example

The signal management plan specifies: detection methods, frequency of review, validation criteria, evaluation procedures, escalation pathways, and decision-making responsibilities.

Regulatory source

EU GVP Module IX

Common mistakes

Having a generic plan that doesn't account for product-specific considerations or resource constraints.

Inspector question

Walk me through your signal management plan. How is it customized for different products?

Related terms