Adverse Trends in the CAPA program are defined as three or more similar major deviations occurring 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. Adverse Trends are defined as three or more similar major deviations. occurring within a rolling 6-month period across different sites.

legacy import — synthesised from supporting_context_primary