Quality
CAPA Effectiveness Check
capa ec · effectiveness verification
In short
A scheduled post-CAPA review proving the corrective/preventive action actually prevented recurrence — not just that the action was implemented.
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.
Regulatory anchors
- 21 CFR 820.100
- ICH Q10
Where this term comes up
Related terms
Software that covers CAPA Effectiveness Check
V5 Ultimate CAPA Software
Root cause, corrective and preventive actions and effectiveness checks sit with the source event, so owners can see what is open…
V5 Ultimate (QMSR)
The FDA Quality Management System Regulation (QMSR) — the harmonized replacement for 21 CFR 820 — became effective 2 February…
V5 Ultimate eQMS Software
Document control, CAPA, deviations, change control, training and audits in one platform, with a rollout plan agreed with you.
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