Remediation

CAPA and Root Cause Analysis

The fix, not just the finding: corrective actions that stay closed.

A corrective and preventive action (CAPA) is only finished when the problem stays gone. We manage CAPAs and run root cause analysis so that the fix is real, not paperwork.

Root cause is the hard part. A closed CAPA that treats the symptom brings the same issue back a few months later, and an auditor will notice the repeat. We work back from what happened to why it was possible, and we write the cause in terms your team can verify.

We build the action around that cause, set an owner and a date, and define how you will show the action worked. That last step is what an investigator asks about.

We can take over a stalled CAPA backlog, rebuild a single CAPA that was closed too early, or run the process alongside your team.

It is the same standard we apply to every remediation: done, and done right.

When to call us

  • “Our last CAPA closed and the issue is back.”

Tell us what FDA, an auditor, or your own team found. We will tell you how we would handle it.

Request a call