Does anyone have any Performance Qualification (PQ) validation protocol for Isensix Wireless Temperature Monitoring Systems? What needs to be included in this?

How much PQ needs to be performed in-house after the vendor performs OQ and IQ?

Any help or procedures related to this will be greately appreciated.

Thank You,

Kashmira Patel MS MT (ASCP) SBB

We are just getting ready to go live with another third party temperature monitoring system. I have not written my PQ yet, so I can't share in writing. Essentially the point of your PQ is to demonstrate that the system works in your specific situation as you need it to work. I would suggest that you could try a modified version of alarm QC where you make the temperature of the probe go up above high warning (if you set one) and high alarm, then low warning and low alarm, and check to be sure that all temperatures are recorded and the proper notification occurred. I am assuming that the IQ included calibration of the probes and the OQ included checking the accuracy of the probe temperature readings. If it did not, that would be important to do also.

Hope this helps!

I was just looking at Isensix as a temp monitoring system. Does anyone have experience with them that would share? How the system works, how the customer support is, etc.

I don't know this particular vendor but when we purchased ours (from Veriteq), the vendor provided a very in depth qualification protocol and was always there when I had questions. We qualified all aspects of the server (where the program resides) to the tune of slightly over 100 pages of fun filled steps. We are a multi site service so will have to qualify each logger at each site (mainly that the alarm goes off). Your vendor ought to supply you with a protocol that you can adapt if needed (personal opinon), it makes life a lot easier!