One of the most consequential inspection changes under QMSR is FDA access to records that previously benefited from specific QS-regulation inspection exceptions.
The old inspection exception is gone
FDA’s QMSR FAQ states that the agency has authority to inspect management review, quality audit and supplier audit reports. The exceptions that existed under the former QS regulation were not maintained.
Treat the underlying evidence as a controlled record set
For readiness purposes, identify where reports, schedules, supporting metrics, approvals and follow-up records live, who owns them, and whether the current evidence is readily retrievable.
Management review evidence should be contemporaneous
FDA enforcement history illustrates the risk of trying to reconstruct management-review history during an inspection. Teams should maintain records as part of normal operations and review their completeness before an inspection occurs.
Audit readiness is not an invitation to rewrite audits
An inspection-readiness review should verify indexing, availability and controlled status. Any substantive correction to a quality record should follow the firm’s established quality-system controls.
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.