FDA has directly addressed what happens to records created before QMSR took effect: investigators may review them, and firms may find comparative analysis useful.
Older records do not disappear on February 2, 2026
FDA explains that records generated before the QMSR effective date may be inspected. When those records were created, manufacturers were required to comply with the QS regulation then in effect.
FDA suggests comparative analysis may be useful
The agency notes that a manufacturer may find a comparative analysis useful to demonstrate that a pre-February 2, 2026 record satisfies current QMSR requirements. That is a useful operational concept, but the firm must perform its own qualified mapping.
A practical reconciliation register
For each material legacy record set, capture the record or procedure, date range, prior basis, the organization’s current mapping reference, evidence location, reviewer, result, identified difference and action. This creates a review trail without rewriting the original record.
Do not manufacture history after the fact
Inspection readiness should emphasize contemporaneous controlled evidence. A reconciliation process can explain and organize older records; it should not be used to create fictional contemporaneous documentation.
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.