Management Review Report
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 | |||||
| (…) |
Template Copyright openregulatory.com. See template license.
Please don’t remove this notice even if you’ve modified contents of this template.
Template Copyright openregulatory.com. See template license.
Please don’t remove this notice even if you’ve modified contents of this template.