CAPA Effectiveness Check

An Effectiveness Check (EC) is the final required step of a CAPA: a defined, measurable verification — usually 3–6 months after closure — that the root cause did not recur. Inspectors routinely cite CAPA programmes that close on implementation alone without an EC.

V5 schedules ECs at CAPA closure, attaches the supporting data (deviation rate, complaint rate, audit findings), and reopens the CAPA automatically if the criterion fails.