Global Quality Events are defined as events impacting multiple geographic regions or sites, resulting in Class I or Class II product recalls, critical audit findings from Regulatory Agencies, or systemic failures in the global Quality Management System (QMS).

It specifically governs 'Global Quality Events,' which are defined as: Events impacting multiple geographic regions or sites. Events resulting in Class I or Class II product recalls. Critical audit findings from Regulatory Agencies (FDA, EMA, MHRA). Systemic failures in the global Quality Management System (QMS).

legacy import — synthesised from supporting_context_primary