Template: Management Review Report

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This is a free template, provided by OpenRegulatory.

If you are a user of Formwork, our eQMS software, choose “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, and then open the relevant folder to find this template ready to load into Formwork.

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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 ReviewXYZ (…)
Participants
(Name, Role)
XYZ (…)
SignatureXYZ (…)

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.

SOPKey Performance IndicatorReview InputManagement AssessmentImprovement MeasuresEvaluation of Previous Measures
Corrective and Preventive Action (CAPA)Quick decision of action plan (goal: max. 1week)Last year: 3 days on averageProcess is followed and complies with requirementsNoneN/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.

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