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IQ, can it stand alone?

Discussion in 'Qualification & Validation (21 CFR Part 11)' started by Airwolf, Jan 2, 2020.

  1. Airwolf

    Airwolf Member

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    Hi guys

    Regarding IQ of an inhouse-built machine, built from other machines and CE-marked etc.

    I want to do an IQ for the installation of the above machine, but there seem to be different
    opinions regarding whether an IQ can 'stand alone' or if it needs to be followed by OQ, PQ.

    So, the machine is done (a tumbler with timer). It has a CE-mark and danger symbols etc. Should
    this machine be subjected to an IQ? If not, how can I make sure that the machine is installed
    correctly with voltage, safety switches, compressed air and more?

    Thanks!
    Nicholas
     
  2. yodon

    yodon Well-Known Member

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    The equipment could still be installed in a manner inconsistent with the manufacturer's recommendations / requirements. So, yes, an IQ is likely a good idea for exactly the reasons you indicate.

    Not completely sure what you mean by "stand alone." Are you asking if nothing else besides OQ needs to be done to qualify the equipment? I'd guess that's unlikely but all decisions should be risk-based (and documented).
     
    Andy Nichols likes this.

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