What is CAPA?
Corrective and Preventive Action: a systematic approach to identifying, investigating, and addressing quality issues. Follows an open, investigate, resolve, close lifecycle.
A corrective action fixes a problem that has occurred; a preventive action stops a potential problem before it does. A defensible CAPA record connects the triggering signal (an excursion, failed result, or deviation), the investigation and root cause, the actions taken with owners and due dates, and an effectiveness check showing the action actually worked.
Inspectors frequently trace a single excursion forward: was it investigated, what was concluded, what changed, and did the change prevent recurrence? A CAPA log disconnected from its source evidence is one of the most common documentation gaps in compounding pharmacies.
See how CompliRx handles this in practice:
CAPA softwareRelated terms
Turn the standard into daily records
CompliRx helps compounding pharmacies keep environmental monitoring, qualifications, cleaning, documents, and CAPA evidence inspection-ready.