This is a collection of rules, procedure, and forms related to CAPA in a form consistent with the FDA QSR.
Management is strongly held accountable during QSR (Quality System Provision) inspections.

List of Forms
The following forms are included with your purchase.
・MD-QMS-K1 Management Review Provision
・MD-QMS-S101 Management Review Procedure
・MD-QMS-F101 QMS Annual Plan
・MD-QMS-F102 Management Review Input & Output

Table of Contents

Provision

1 PURPOSE
2 SCOPE
3 DEFINITIONS OF TERMS
4 Responsibility and Authority
5 Development and update of annual QMS plan
6 Convening Management Review Meeting
6.1 Term of Meeting
6.2 Responsibility of the meeting
6.3 Members
6.4 Meeting Requirements
6.5 Calling
6.6 Procedure for members absent of Management Review Meeting
7 Input for Management Review Meeting (Preparation for meeting materials)
8 Review and Discussion
8.1 Review
8.2 Decisions and Handling
9 Preparation of Records
10 Maintenance of Records
11 REFERENCE
12 APPENDICES

Procedure

1 PURPOSE
2 SCOPE
3 DEFINITIONS OF TERMS
4 Responsibility and Authority
5 Development and update of annual QMS plan
6 Convening Management Review Meeting
6.1 Calling Management Review Meeting
6.2 Preparation of Management Review Meeting by Bureau
6.3 Confirmation for establishment of Management Review Meeting
6.4 Discussion in Management Review Meeting
6.5 Preparation of records for Management Review Meeting
6.6 Procedure for members absent of Management Review Meeting
6.7 Maintenance of Records for Management Review Meeting
7 Temporary Management Review Meeting
7.1 Calling Temporary Management Review Meeting
7.2 Discussion in Temporary Management Review Meeting
7.3 Maintenance of Records for Temporary Management Review Meeting
8 REFERENCE
9 APPENDICES