Turn QMSR review findings into a structured, traceable action plan.
The AVRA QMSR Gap Assessment Workbook is a practical Excel tool for medical-device manufacturers, startups, importers, and quality or regulatory teams preparing for the FDA Quality Management System Regulation. It provides a consistent place to document what was reviewed, the objective evidence available, the gaps identified, and the actions required through closure.
What the workbook helps you document
- Applicable QMSR and quality-system review points
- Existing procedures, records, and other objective evidence
- Observed gaps and their potential compliance impact
- Priority, responsible owner, and target completion date
- Corrective or remediation actions
- Follow-up evidence and closure status
What is included
- Six organized Excel worksheets
- Structured fields for findings, evidence, risk, ownership, actions, and closure
- A reusable format for internal assessment and remediation tracking
- Unlimited internal use by the purchasing organization
Who it is for
Designed for medical-device quality and regulatory professionals, finished-device manufacturers, startups establishing or updating their quality systems, and teams organizing QMSR readiness activities.
How to use it
Begin with the free QMSR Transition Checklist to identify areas that deserve review. Use this workbook when you need to record the assessment in greater detail, assign responsibility, track remediation, and retain an organized history of closure.
Format: Microsoft Excel (.xlsx)
Delivery: Digital download after purchase
License: Unlimited internal use by the purchasing organization
This workbook is provided as a practical organizational tool. It does not constitute legal or regulatory advice and does not, by itself, establish or demonstrate compliance.