Regulatory Open Forum

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  • 1.  Service Report - Customer Signatures

    Posted 11-Jul-2019 09:35
    I work for the service side of our medical device manufacturing business. We install and service our equipment. Are we required to obtain the customer's signatures on completed service reports?

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    [Whitney] [Davis]
    [Quality Specialist III]
    [Instrument and Enterprise Services]
    [Thermofisher Scientific]
    [Marietta] [OH]
    [USA]
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  • 2.  RE: Service Report - Customer Signatures

    Posted 11-Jul-2019 12:19
    It is always a best practice to review and get a sign off from the customer to keep it for your records. More than from a compliance perspective, this closes the action that you have performed on the equipment. This would also ensure further issues  can be handled effectively (e.g. customer complaining about the quality of service, service documentation etc.)

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    Loganathan Kumarasamy, MS RAC
    Senior Consultant
    Waukegan IL
    United States
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