Adverse Trends in the CAPA program are defined as three or more similar major deviations within a rolling 6-month period across different sites so that significant issues can be identified early.

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

legacy import — synthesised from supporting_context_primary