Qualification procedure for equipment in a form consistent with FDA QSR.

List of Forms
The following forms are included with your purchase.
・MD-QMS-S707 Equipment Qualification Procedure
・MD-QMS-F771 FMEA Sheet
・MD-QMS-F772 Qualification Plan for Equipment
・MD-QMS-F773 DQ Implementation Results
・MD-QMS-F774 IQ OQ Implementation Results
・MD-QMS-F775 PQ Implementation Results

Table of Contents

Procedure

1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Roles and Responsibilities
5 Qualification of equipment implemented
5.1 Implementation Flow
5.2 implementation procedure
5.2.1 Conduct FMEA
5.2.2 Qualification Plan Preparation
5.2.3 DQ (Design-Qualification)
5.2.4 IQ (Installation Qualification) and OQ (Operational Qualification)
5.2.5 PQ (Performance Qualification Qualification)
5.3 requalification
6 Record keeping
7 form
8 reference
9 by-laws