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  • 1.  Evidence of MDSAP audit

    This message was posted by a user wishing to remain anonymous
    Posted 11-Mar-2020 12:14
    This message was posted by a user wishing to remain anonymous

    Hi RA folks,

    I have a question regarding the MDSAP audit.
    Is there a attendance form issued by the auditor after the conduct of the stage 1 and 2 audit? I am not sure, however, I heard there is a Z-form/report issued. Any insight on this? Does anyone has a template of this form or a link from where it can be downloaded? Is this accepted by the authorities as an evidence that the audit occurred?

    Thanks in advance!


  • 2.  RE: Evidence of MDSAP audit

    Posted 12-Mar-2020 10:23
    Hi Anon,
    I'm not sure what you mean by "Z-form".
    There are 3 documents issued after the completion of an MDSAP audit:
    • Form with any nonconformities
    • MDSAP full report
    • MDSAP certificate


    ------------------------------
    Hiral Dutia
    Sr. Regulatory Affairs Specialist
    Third Pole Therapeutics
    Waltham, MA
    USA
    ------------------------------

    Original Message


  • 3.  RE: Evidence of MDSAP audit

    Posted 12-Mar-2020 13:55
    I recall that there is a page of the names and roles of the attendees included in the first section of the audit report. I don't know what a Z-form is; it might be the audit report that's issued at the end using a standard fillable template. Check the link below and see if it can help you navigate to the appropriate document. 

    https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-documents

    Good luck with the audit.
    Jo

    ------------------------------
    Jo Huang RAC
    Assoc Manager - Regulatory Affairs
    Irvine CA
    United States
    ------------------------------

    Original Message


  • 4.  RE: Evidence of MDSAP audit

    Posted 12-Mar-2020 16:42
    Edited by Brittany Gibson 12-Mar-2020 16:42
    Hi Anon,

    The names of these forms may be specific to certain auditing organizations.  In my experience, a Z1 visit receipt & A7 coversheet was signed after both stage 1 and stage 2 MDSAP audits, as was the case for prior ISO 13485 audits.  There is no template or link to download from because these forms are provided by the auditing organization and signed by both the manufacturer representative and the auditor to acknowledge the assessment occurred.  

    As for whether or not authorities accept the Z1 form as evidence of the audit, it would depend on which authority, but for Canada, it wouldn't be accepted.  Health Canada was accepting "MDSAP Audit Confirmation Notification" documents, issued by the auditing organization, as evidence of an MDSAP audit occurring (see the guidance here https://www.fda.gov/media/89192/download).  However, Health Canada's arrangements with manufacturers to transition into MDSAP after the deadline was only for 2019.  As far as I'm aware, there's no information about accommodations being made in 2020 and the MDSAP certificate is required with all new applications to Health Canada.

    Good luck with the audit!

    ------------------------------
    Brittany Gibson BSc
    Director, Quality and Regulatory Affairs
    Winnipeg MB
    Canada
    ------------------------------

    Original Message


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