NOTE #1: This template is supposed to give you an idea of the structure. Don’t use MS word – this is thought as an excel / sheets file.
NOTE #2: Think of the sub-sections below as different tabs in your excel sheet.
Overall Assessment
Overall QMS Assessment:
NOTE: Assess the general adequacy, suitability and efficacy or QM system to comply with regulatory requirements. Also take into account an assessment of the criticality / impact of single processes for product safety. List a summary of measures derived from the review.
| Date of Review | XYZ (…) |
| Participants (Name, Role) | XYZ (…) |
| Signature | XYZ (…) |
Process Assessment
NOTE: In your excel sheet, you may want to create one tab for every process and include results from previous Management Reviews for comparison.
| SOP | Key Performance Indicator | Review Input | Management Assessment | Improvement Measures | Evaluation of Previous Measures |
|---|---|---|---|---|---|
| Corrective and Preventive Action (CAPA) | Quick decision of action plan (goal: max. 1week) | Last year: 3 days on average | Process is followed and complies with requirements | None | N/A |
| Change Management | |||||
| Document and Record Control | |||||
| Software Development | |||||
| Management Review | |||||
| (…) |
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