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The FDA’s New Playbook: Preparing for Inspections Under the QMSR

As of February 2, 2026, the medical device industry officially entered a new regulatory era. The long-anticipated transition is complete: the Quality Management System Regulation (QMSR) has modernized 21 CFR Part 820 by integrating ISO...

Tips & Advice ► February 28, 2022

The Fallacy of the “Original Paper Record”

It happens at least a few times a year as I interface with pharma/bio/med tech clients. We start talking about computerized system use or data integrity of records, and I invariably hear some version of:...