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Compliance Intelligence Hub

Expert perspectives and essential resources to navigate the evolving global GxP landscape with certainty.

Beyond the Transition: Navigating Unannounced Inspections Under 21 CFR 211

The FDA has officially shifted from episodic preparation to continuous inspection readiness.

Official Regulation: 21 CFR Part 820 (QMSR)

As of February 2, 2026, the FDA has replaced the QSR with the new QMSR.

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