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Digital Tools and Software

CAPA Management System

The fix, and the proof the fix worked

A corrective action fixes this occurrence. A preventive action removes the cause that produced it.

We hold cause, corrective action and preventive action as distinct records and schedule effectiveness verification against each one, so the check happens whether or not anyone remembers. A system that does not separate the two ends up recording the same sentence twice and calling it prevention.

A quality engineer verifying equipment against a checklist in a clean production area

Raise

From an incident, audit finding, deviation or complaint, with the source preserved.

Investigate

Cause established at system level, not at the individual who was present.

Correct

The immediate fix, scoped to the specific failure.

Prevent

The wider condition addressed, as a separate record with its own test.

Close

Objective evidence attached, not a claim that work was done.

Verify

Effectiveness checked at an interval set by risk, and reopened if it failed.

Preventive action is a separate record with its own test. If it can be satisfied by restating the corrective action, it was never a preventive action.

Built for inspection, not just for storage

For regulated operations we configure electronic signature, record integrity and controlled reopen so the record satisfies inspection rather than merely being stored electronically. Extension and reopen are controlled events carrying a justification.

A quality engineer verifying equipment against a checklist in a clean production area

Verification will sometimes fail

Effectiveness verification will fail sometimes, and a failed verification reopens the CAPA rather than closing it. A process where nothing ever fails verification is one where the check is a formality.

Separate the corrective action from the preventive one

We will come back with the record structure, the effectiveness verification schedule and what the build would cost. Tell us how a CAPA is raised, closed and verified today.

Start a scoping call