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Document Record Numbers

Discussion in 'Documentation Control, Procedures, Templates,...' started by Karly Chester Etzel, Aug 21, 2018.

  1. Karly Chester Etzel

    Karly Chester Etzel New Member

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    I'm working to transfer all of our paper documents into electronic copies managed in our EQS.
    We're currently working with ISO13485 and 21CFR 820 as our frameworks for our QMS. We've also started to incorporate 21 CFR 211

    We are also implementing a record numbering system at the same time.

    My question is: What's the acceptable way of adding record numbers to existing records?
    We've determined that we will add a box that says:

    Quality Record #:_____________
    Assigned By: ___________
    Date:________

    I'm wondering if we need to add these by hand and then scan the documents or if we can add in the box on the PDF before we protect the document and file it.

    Thank you for your help
     
  2. yodon

    yodon Active Member

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    Sorry for the delayed reply.

    I guess my first question would be to ask why you want to add record numbers to existing records? Are you solving a specific problem? What would the date line be for existing records?

    On the surface, it sounds like you're making things more complicated than they need to be.

    Regardless, since you'll be storing electronic records, don't forget 21 CFR 11. In all cases, data integrity needs to be maintained so as long as you do that and provide the required protection (and audit trail, etc.), the approach you take is up to you.
     
    Jennifer Kirley likes this.
  3. Karly Chester Etzel

    Karly Chester Etzel New Member

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    The records have not been assigned a record number. The paper document is filed in a folder and a quality record number has never been assigned. I am trying to address this gap in our QMS. In order to load them into our Electronic QMS I will need to assign each one a record number.

    We are Part 11 compliant and have validated our system using according to GAMP 5 guidelines. Thank you for bringing up this point.

    Sorry for the late reply and thank you for your help!
     
    Atul Khandekar likes this.

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