The Global Quality Intelligence (GQI) team must continuously monitor inputs to the CAPA program, including adverse trends, external signals, and internal signals, to ensure timely identification of issues so that appropriate corrective actions can be implemented.

Inputs to the CAPA program shall be continuously monitored by the Global Quality Intelligence (GQI) team. Adverse Trends: Three or more similar major deviations within a rolling 6-month period across different sites. External Signals: Regulatory inspection findings (FDA 483s), Customer Complaints with safety implications. Internal Signals: Management Review outcomes, significant audit non-conformances.

legacy import — synthesised from supporting_context_primary