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 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 (…)|
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|
|Document and Record Control|
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