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  • 1.  QMS Document Control Check

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jan-2022 12:53
    This message was posted by a user wishing to remain anonymous

    Hi All
    Can anyone share a Document Control check - checklist. 
    What does Document Control check at the end of a document approval process? 
    Many thanks!


  • 2.  RE: QMS Document Control Check

    Posted 27-Jan-2022 13:41
      |   view attached
    Attached is a sample of a final medical device document control checklist demonstrating what needs to be assured at the end of a document approval process either manually or via the eQMS.  Per the limited scope of your question, this is just for the final administrative step, whereas more substantive approval steps (like the need and adequacy of supporting verification or validation) are instead addressed earlier in the process.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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    Attachment(s)

    pdf
    202201 Document Control Final Checklist.pdf   120 KB 1 version
    Original Message


  • 3.  RE: QMS Document Control Check

    This message was posted by a user wishing to remain anonymous
    Posted 28-Jan-2022 12:53
    This message was posted by a user wishing to remain anonymous

    Thank you very much! 
    I would add to that check that all approvers approved the document ( according to the matrix) 
    I wonder if anything else is missing.
    Original Message


  • 4.  RE: QMS Document Control Check

    Posted 28-Jan-2022 13:30
    Edited by Kevin Randall 28-Jan-2022 13:35
    Further to the scope limitation in my original post, the intent of the sample final administrative checklist is for the final document admin tasks that happen after document approval.  As noted before, more substantive approval steps (like the recording of all stakeholders approval) happens in the preceding steps of the process.  Specifically, in the illustrated sample, the corresponding SOP is that the final change administration (step 6) doesn't happen (manually or in an eQMS) until the prior steps are completed (i.e., like step 5 where all stakeholder signatures/approvals are obtained).

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


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