Under QMSR, the practical inspection-readiness question is not simply whether a procedure exists, but whether relevant records can be discussed and produced when FDA asks for them.
Management review, quality audits and supplier audits changed materially
FDA explicitly says it has authority to inspect management review, quality audit and supplier audit reports under QMSR. The prior QS-regulation exceptions at § 820.180(c) were not retained.
Readiness is broader than three record categories
Inspection preparation should also consider the records generated by the manufacturer’s own QMS processes: supplier controls, complaints, nonconformity and corrective-action work, training and competency, document control and other applicable records. The exact universe depends on the firm, its devices and applicable requirements.
Avoid creating an inspection-only shadow system
The strongest readiness process indexes and reviews controlled records already maintained in the ordinary course of business. An evidence map should point to source records rather than replace them with disconnected copies. A QMSR inspection evidence map can connect each request to its controlled source without creating a shadow record set.
Retrieval matters
FDA’s FAQ says relevant records should be readily available upon inspection. An internal index that captures owner, location, date/version and review status can make retrieval problems visible before an investigator is waiting.
FDA QMSR Inspection Readiness & Evidence Control System
Organize QMS evidence, inspection requests, record reviews, pre-2026 reconciliation and corrective actions in one reusable Excel workbook.
Official FDA resources
- FDA Quality Management System Regulation (QMSR)
- FDA QMSR Frequently Asked Questions
- CDRH Compliance Programs — CP 7382.850
This article is operational information, not legal advice and not a substitute for the QMSR, incorporated standards, FDA guidance, or qualified regulatory/quality advice.