FDA QMSR Inspection Readiness & Evidence Control System
FDA QMSR Inspection Readiness & Evidence Control System
An Excel-based inspection-readiness system for medical device manufacturers operating under FDA’s new Quality Management System Regulation (QMSR).
FDA’s QMSR became effective February 2, 2026, changing the framework FDA uses to inspect medical-device quality systems and replacing the former QSIT inspection approach.
The FDA QMSR Inspection Readiness & Evidence Control System helps quality and regulatory teams organize the records, evidence, responsibilities, and open issues they may need to manage before and during an FDA inspection.
Rather than trying to reconstruct an evidence trail after an investigator requests it, the system helps you build and maintain inspection readiness as part of normal operations.
What the System Helps You Control
• Management-review records and supporting quality data
• Internal quality-audit evidence
• Supplier qualification, monitoring, and audit records
• CAPA and nonconformance evidence
• Complaint and postmarket records
• Training, qualification, and competency evidence
• Controlled procedures and document versions
• Record ownership and retrieval locations
• Pre-February 2026 record reconciliation
• Inspection document requests and responses
• Evidence gaps and corrective actions
• Overall inspection-readiness status
Included Worksheets
Dashboard — At-a-glance view of evidence readiness, open requests, record gaps, legacy-record reviews, and high-priority actions
Evidence Map — Create a central index of inspection-relevant QMS records, owners, versions, locations, and readiness status
Inspection Requests — Log investigator or mock-inspection requests, assignments, deadlines, evidence locations, responses, and follow-up
QMS Record Review — Review whether important records are current, approved, traceable, and readily retrievable
Pre-2026 Reconciliation — Document review of quality records created before the February 2, 2026 QMSR effective date and identify areas requiring additional analysis or evidence
Issues & Actions — Turn inspection-readiness gaps into assigned, prioritized corrective actions with documented closure evidence
Inspection Readiness — Perform a structured final review across major evidence areas before an inspection
Sources & Scope — Maintain the official FDA sources underlying the system and its intended compliance boundaries
Designed for the New QMSR Inspection Environment
FDA has stated that investigators may review QMS records created before February 2, 2026, and that manufacturers may find a comparative analysis useful when evaluating how older records satisfy current QMSR requirements.
The system gives your team a structured place to perform and document that operational review without attempting to replace your existing QMS.
Who This Is For
Designed for:
• Medical device manufacturers
• Quality managers
• Regulatory affairs teams
• Quality assurance personnel
• Internal compliance teams
• Smaller device companies preparing for FDA inspection
• Consultants assisting manufacturers with inspection readiness
Format: Microsoft Excel workbook
Price: $149 one-time
Instant digital download
No subscription
This product is an operational inspection-readiness and evidence-control aid. It does not provide ISO 13485:2016 text, determine whether a quality system complies with QMSR or ISO 13485, replace required procedures or records, conduct an internal audit, provide legal advice, guarantee an FDA inspection outcome, or replace qualified regulatory or quality professionals.