CAPA stands for corrective and preventive action. A corrective action removes the cause of a nonconformity that has already occurred — a deviation, an out-of-specification result, an audit observation or a complaint. A preventive action removes the cause of a potential problem before it happens, often identified from trends, risk assessments or near misses.
A CAPA is more than a to-do list. It starts with a documented investigation and root cause, then defines actions with owners and due dates, verifies that each action was done, and finally checks whether the problem has actually stopped. That last step — the effectiveness check — is where many quality systems are weakest.
Why it matters in GMP
CAPA sits at the heart of the pharmaceutical quality system described in ICH Q10, and it is one of the first areas an inspector samples. Common findings include CAPAs that treat symptoms rather than causes, actions closed without evidence, overdue CAPAs with no approved extension, and no link back to the event that triggered them.
- Every CAPA should trace back to its source record and forward to its evidence of completion.
- Overdue actions need a documented, approved extension — not a silent date change.
- Effectiveness should be judged against a defined criterion, after enough time has passed.
How Swat iQua Suite handles it
In Swat iQua Suite a CAPA can be raised standalone or directly from a deviation, OOS investigation, lab quality event, audit observation, stability failure or audit trail review finding — and a source-raised CAPA is approved together with its source. Preparer, reviewer and approver must be different people, an action’s verifier cannot be its owner, and a hard overdue gate blocks final closure unless an extension has been approved. An optional effectiveness review runs before the CAPA closes, and a daily digest emails owners about overdue items.