OpenRegulatory Template

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 (…)
(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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