FDA QMSR Inspection Readiness Checklist

FDA says firms inspected on or after February 2, 2026 should be prepared to discuss and provide records that demonstrate compliance with QMSR requirements.

Start with the inspection-process change

QMSR became effective February 2, 2026, and FDA stopped using QSIT for device inspections. The replacement process is described in Compliance Program 7382.850. A readiness review should therefore be built around the current regulation, your own controlled QMS, and the records your team can actually retrieve.

Build an evidence index before inspection day

Create an index of important QMS records with an owner, current version or date, controlled location and readiness status. The purpose is not to create duplicate records; it is to make the existing evidence trail visible and retrievable.

Include management review and audit evidence

FDA states that the QMSR permits inspection of management review, quality audit and supplier audit reports; the former QS-regulation exceptions were not maintained. Treat those records as part of the inspection-readiness universe.

Review older records deliberately

FDA says investigators may inspect records created before February 2, 2026 when evaluating current compliance and notes that manufacturers may find comparative analysis useful. Document your own review rather than assuming an older record automatically maps to a current requirement.

Test the request-and-response workflow

Assign who receives requests, who locates records, who reviews them before provision, how response status is logged, and how follow-up is controlled. A mock request exercise can reveal retrieval and ownership problems before a real inspection.

Official FDA resources

• FDA Quality Management System Regulation (QMSR)
• FDA QMSR Frequently Asked Questions
• CDRH Compliance Programs — CP 7382.850