The Phantom CAPA

Following a major audit finding, a global medtech company initiated a CAPA across three sites. Each site entered the CAPA into their local quality system.

Three months later, none of the entries matched. The root cause was documented differently in each system. The corrective actions contradicted each other. Effectiveness checks were scheduled for different dates using different criteria.

When the next audit came, the auditor found three phantom CAPAs — each claiming resolution, none actually resolving anything.

The resulting 483 observation cost $4.2M in remediation, external consulting, and expedited system integration.

The CAPA existed everywhere. It worked nowhere.

With governed CAPA orchestration, a single evidence-linked corrective action would span all sites with consistent root cause documentation, unified corrective action tracking, and automated effectiveness verification.