FDA changed both the quality-system regulation and the inspection process.
The Quality Management System Regulation became effective February 2, 2026. FDA also stopped using QSIT and began using the inspection process in Compliance Program 7382.850. FDA tells manufacturers to be prepared to discuss and provide records demonstrating compliance with QMSR requirements.
FDA's QMSR FAQ also states that management review, quality audit and supplier audit reports can be inspected under QMSR, and that investigators may review records created before February 2, 2026. The Syntera system is designed to help teams know what evidence exists, where it lives, who owns it, what still needs attention and how inspection requests are being handled.
Eight working tabs
- Dashboard — evidence readiness, open requests, record gaps, legacy reviews and priority actions
- Evidence Map — central index of inspection-relevant records, owners, versions, locations and status
- Inspection Requests — request, assignment, due date, evidence location, response and follow-up log
- QMS Record Review — review whether records are current, approved, traceable and readily retrievable
- Pre-2026 Reconciliation — document review of older records and your organization's current mapping/reconciliation work
- Issues & Actions — prioritize gaps, assign owners and document closure evidence
- Inspection Readiness — structured final readiness review across major evidence areas
- Sources & Scope — official FDA references and product boundaries
This product focuses on evidence control and inspection operations. It does not reproduce ISO 13485 text or make compliance determinations for the user.
Read the free guide: FDA QMSR Inspection Readiness Checklist
Reusable workbook for evidence indexing, inspection requests, record review, legacy reconciliation, readiness gaps and corrective actions.
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