Good Clinical Practice Guide
Results 1 to 2 of 2

Thread: Using two devices for monitoring temperature

  1. #1
    Forum Member
    Join Date
    Nov 2011

    Using two devices for monitoring temperature

    Dear all,

    I need your kind suggestion in regards to temperature monitoring.
    Normally we use min/max thermometer for daily monitoring of temperature. Also we use data loggers as back up device, as we know sometime thermometer may show some deviations due to battery fault or any other faults.

    Recently I have been told by sponsor that we only allowed to use one device either data logger or min/max thermometer. To what extent you will comfortable with this comment.

  2. #2
    Forum Member
    Join Date
    Nov 2011
    The sponsor may be concerned with two (conflicting) sets of data being recorded. The MHRA has recommended in the past, a risk based approach should be taken to the need for and the degree of requirement for back-up devices needed, for temperature monitoring. An SOP or note to file could state what is the primary device and what is the back-up in case of failure etc. However, unless there is a very good argument for two devices, one should normally suffice. Watch out for the old trick of identifying the measuring device and the area being monitored on the documented recording. Also make sure that the documentation (including validation and servicing/maintenance) are readily available for inspections.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts