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Service Desk system - Software Validation

Discussion in 'Qualification & Validation (21 CFR Part 11)' started by Micheli Lermen, Jun 13, 2018.

  1. Micheli Lermen

    Micheli Lermen Member

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    Dears,

    I need to know your opinion about the need for a system validation for a healthcare warehouse company it service desk software.

    My point is, our WMS is validated, so when users(managers) send us a request to create a WMS access in our Service desk system, we request a manual form and manual signature because it has always been done like this and like our Service desk system doesn't have some FDA´s requirements, we opted to do like this.

    Now, thinking about improvements in this scenario, do you have ideas? Do you know compliance service desk systems?

    Do you think this manual effort is really needed?


    Our IT sd software is open source- GLPI.
     
  2. yodon

    yodon Active Member

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    If I understand, your service desk system software is only to request service from your IT department (which could include creation of a WMS [Warehouse Management System?] user account)?

    (Non-product) software validation is only required where the software supports some aspect of the QMS. If I understand the situation correctly, the service desk software would not be in scope for validation required under 21 CFR 820.

    As far as the manual effort goes, that would be up to you. If there's no added value, why do it? If it provides the tracking to show the correct access was given to the new user account, then maybe it's still needed.

    Hopefully I'm at least close to answering your questions. :)
     

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