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IQ/OQ/PQ
Installation Qualification (IQ)
• A description of the MadgeTech system
• Verification that all MadgeTech system equipment, software and accessories are
received in good condition
• A check for complete documentation
• Verification that the installation of MadgeTech equipment is completed properly
• Verification that MadgeTech 4 Secure Software is installed properly on the target
workstation
• Verification of basic communication between MadgeTech data logger(s) and the
target workstation(s)
Operational Qualification (OQ)
• Functional verification of MadgeTech data loggers
• Handling and maintenance information for the use of MadgeTech equipment
• MadgeTech operating procedures for primary functions
• Verification of proper communication between the MadgeTech data logger(s) and the
workstation(s)
• Verification that the data logger hardware is operational
Performance Qualification (PQ) Recommendation
• Additional handling precautions for maintaining the accuracy of MadgeTech equipment
• Periodic maintenance information for the use of MadgeTech equipment
• Periodic calibration verification in the field
• Comparison of the reported values to a known good standard
• Verification of acceptable performance in the target system
Meeting compliance with regulations for the FDAs Good Manufacturing Practices, or those set forth in Quality Plans, has become increasingly
complex. MadgeTech has simplified this process by including IQ/OQ/PQ protocols with its MadgeTech 4 Secure Software package.
This enormous time and money saving feature eliminates the need to develop in-house software validation procedures. The MadgeTech IQ/OQ/
PQ protocol is in support of FDA and cGMP guidelines. In addition, MadgeTech offers a Software Validation Workbook to help the user verify the
functionality of the software.
IQ/OQ/PQ Validation Protocol