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← Document libraryCorrective and Preventive Action (CAPA)
Fictional document for the demonstration.
§4.1 Initiation
A CAPA is raised when a deviation, audit finding or trend shows a systemic cause. Each CAPA names an owner, a due date and a risk rating under ICH Q9.
§5.2 Effectiveness check
An effectiveness check is defined at CAPA approval and run after a monitoring period of at least 90 days. A CAPA is closed only when the check shows no recurrence.
§5.3 Overdue actions
A CAPA action more than 30 days overdue is escalated to the Head of Quality Assurance with a revised plan.