Qualification

 

With the use of Eupry Qualification protocol, you can ensure GxP compliance, by utilizing a tailor-made qualification protocol for qualifying temperature and humidity monitoring.

 

You will receive our qualification protocol, which you can either fill out yourself or have us do it. This will ensure that all relevant qualifications have been performed, as required by GxP requirements.

How to use it

 It is easy to use the qualification protocol. It consists of a series of tests that needs to be performed, to ensure that the temperature or humidity monitoring and alarm system has been properly installed (IQ), that all settings are done correctly (OQ) and that the organization has implemented all operating procedures to handle alarms and deviations (PQ).

A few questions for the quality manager?

Jakob Konradsen, MSc from the Technical University of Denmark

Jakob Konradsen Eupry

 

Head of Quality and Production at Eupry Civil Engineering, M.Sc. Electronics engineer advises customers in compliance in connection with monitoring of temperature-sensitive assets as well as making qualification and mapping exercises. Has a background as a civil engineer from the Technical University of Denmark in instrumentation and Space Electronics. In collaboration with Eupry’s R&D team, has developed “The Intelligent Calibration System” supported by the Innovation Fund. Teaches and lectures in the development of sensor electronics

Talk to Jakob

Different steps

Qualification of the system involves 4 different steps, although not all organization choose to involve all 4, it all depends on the level of qualification needed.

  • DS / DQ

The design specification and design qualification ensure that an organization has a clear idea of what the specific requirements are in the organization and the use that it has for a temperature monitoring system. Furthermore, it ensures that the purchased system fulfills these requirements.

 

  • IQ

The installation qualification part ensures that everything has been installed to the specifications set forth by the supplier (Eupry), and that it has been checked that everything is functioning as it should at the time of installation.

 

  • OQ

The operational qualification ensures that the system performs as specified in the design specification and as per the suppliers’ specification when it has been installed in the setting it is to operate in. In other words; does the system operate properly in the specific setting where it has been installed and has everything been set up correctly in the Eupry Logger online system.

This is also the part where calibration is checked, and the correct set up of users and so forth is ensured.

 

  • PQ

The performance qualification is often an optional step and helps to ensure that the system has been properly integrated into organizations quality systems. It helps to qualify the employment of standard operating procedures to handle all aspects of the system’s performance and operation.

Normally a qualification is done during first use or during major changes to the setup, and documentation for the conformant fulfillment of the protocol should be kept in your quality system.

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