Data Logging System IQ/OQ/PQ On-site Services

MadgeTech now provides on-site IQ/OQ/PQ services to help the user validate the data logging system.Our trained staff are familiar with the standard IQ/OQ/PQ protocols of the MadgeTech data logging system. This service is a cost-effective means to save time and ensure proper implementation of IQ/OQ/PQ of the MadgeTech data logging system with a minimal disruption to staff and operations.

Key Benefits

• Custom IQ/OQ/PQ protocol generation
• Product/protocol expertise
• On-site qualification by trained individuals
• Recommendations for PQ and ongoing maintenance
• Comprehensive qualification report supplied upon completion
  
  

A member of the MadgeTech staff will provide the protocol and on-site services to expedite the required MadgeTech data logging system validation. We will work with the end user to conduct test protocols including IQ, OQ and PQ. As part of this validation service, MadgeTech will provide protocols and a comprehensive final report that documents all testing that was performed and results that were obtained. Recommendations will be made for testing worst-case and normal operating conditions of the instruments, future performance qualification and on-going maintenance. Certified operator training will also be provided as part of the completion of the service.

MadgeTech performs extensive product qualification testing prior to releasing new products to the marketplace. This includes independent testing of the hardware and software components, as well as integrated testing of the complete data logger system. Despite this detailed testing, regulatory agencies still require that the end-user validate the data logging system in the environment in which it will be used. This validation process includes installation qualification(IQ), operational qualification(OQ) and ongoing performance qualification(PQ). MadgeTech offers standard protocol templates and on-site services to help end-users fulfill their validation requirements.

Data Logging System IQ/OQ/PQ Protocol

MadgeTech provides the IQ/OQ/PQ protocol to establish that the MadgeTech system has been received as specified, is properly installed on the computer in the selected environment, that this environment is suitable and appropriate for use of the MadgeTech system and that proper communication occurs between the MadgeTech data logger(s) and the computer. In addition, this protocol will verify that proper communication occurs between the MadgeTech data logger(s) and the computer, that the MadgeTech system functions and performs as specified on the computer in the selected environment and will provide a basic framework for typical use of the system.

The ordering information for the IQ/OQ/PQ protocol is shown below:
P/N: SVP-Standard-2.00.63
Description: IQ/OQ/PQ Protocol for MadgeTech Standard 2.00.63 Software

AREAS EVALUATED

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 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) Recomendation

• 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

For more information or to arrange for an on-site visit, please contact MadgeTech at (603) 456-2011.