Insights
Field notes from the front line of quality.
Practical guidance from Globiox SMEs — FDA readiness, auditing, CAPA, validation, and quality systems for regulated life sciences.
AllAuditing (3)Company News & Events (7)FDA & Compliance (9)Insights (1)Medical Devices (5)Quality & Validation (7)Warning Letters (2)
Quality & Validation
High frequency of CAPA related observations in warning letters
Editor’s note (August 2026): On February 2, 2026, FDA’s Quality Management System Regulation (QMSR) replaced the Quality System Regulation, incorporating ISO…
July 18, 2013FDA & ComplianceWarning Letters: What they are, How we can help
As discussed in our previous post, “FDA 483: your company contains critical errors,” a company whose operations are not compliant with the regulations set out…
October 9, 2012Ready to get inspection-ready?
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