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IQ and OQ for assembled machine

Discussion in 'Qualification & Validation (21 CFR Part 11)' started by Airwolf, Oct 29, 2019.

  1. Airwolf

    Airwolf Member

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    I am unsure if this is the correct subforum! But here goes:

    I have recently finished the IQ report for an assembled machine, created from other machines. I had the assembled machine locked down regarding hardware and software. I am now ready to do the OQ, but since a joint on a robot arm broke down, the installation of a new one ended with the robot control software being updated.

    Now, what do I do about that?

    Any advice would be greatly appreciated

    /Nicholas
     
  2. yodon

    yodon Active Member

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    Validation (qualification) is never (should never be) a one-time thing. As events occur, follow-up actions are often warranted. Your overall (master) validation plan should help you drive what to do in the event of such changes. Depending on the risk associated with the equipment operations, you may need to do some level of re-qualification after cleaning / maintenance.

    Did your IQ address anything regarding the software? If so, at least that would have to be re-done.

    Since you mention software, do realize that the software itself should be validated. You posted in the Part 11 forum so if it's managing electronic records that fall under the regulation, there's a bit more burden for (software) validation.
     
  3. Airwolf

    Airwolf Member

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    yodon, thanks for your reply. I did an IT change for the version update, and concluded (along with the machine build department) that no functions or the like were changed.

    Thanks!
     

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