Most laboratories don’t fail audits in the conference room.
They fail quietly, weeks or months earlier, when systems drift, assumptions accumulate, and defensibility erodes unnoticed.

Passing an audit may confirm compliance at a moment in time, but it does not guarantee that documentation, data integrity, or governance would hold up under deeper scrutiny. This article explores where audit failures actually begin, why “fixing findings” rarely reduces risk, and how regulatory gap analysis creates clarity before pressure forces the issue.