Laboratory Consulting Blog | Insights and Resource
Recent Articles:
Closing a CAPA Isn't the Same as Fixing the Problem
Novo Nordisk found the problem themselves. Opened a deviation. Identified the root cause. Documented the corrective actions. Then closed it without confirming anything was fixed. FDA showed up and found the same problem still running. This isn't a Novo Nordisk story — it's a QMS story.
Why Most Laboratory Audits Fail Before the Auditor Arrives
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.
Your Lab Doesn’t Need a Ransomware Attack to Fail an Audit
Most laboratories don’t fail audits because of cyberattacks. They fail because data integrity can’t be proven after routine system failures, restores, or IT fixes.