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ISO (80002)

Discussion in 'Qualification & Validation (Also 21 CFR Part 11)' started by Micheli Lermen, Jul 16, 2018.

  1. Micheli Lermen

    Micheli Lermen Member

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    Dears,

    Do you think ISO (80002) could be used instead of gamp 5, if we are talking about a company that works only with warehouse of drugs and medical devices ?
     
    Micheli Lermen, Jul 16, 2018
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  2. yodon

    yodon Well-Known Member

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    If you're talking about in general for non-product software validation, then yes. Neither are specifically required by regulation and both take a risk-based approach.

    You posted in the Part 11 forum, though, and neither deal directly with the aspects of electronic records / electronic signatures called out in the Part 11 regulation. Of course, they can be used to demonstrate compliance to Part 11 but you have to explicitly address the Part 11 requirements.
     
    yodon, Jul 16, 2018
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  3. Micheli Lermen

    Micheli Lermen Member

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    Ah, ok, thank you for this... my only doubt still about the 'scope' of 80002/2017, "Medical device software -- Part 2: Validation of software for medical device quality systems"
    We should consider also drug warehouse ?

    it's really confusing me. Thanks Yodon...
     
    Micheli Lermen, Jul 16, 2018
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