Regulatory Open Forum

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  • 1.  Electronic Signatures in Adobe PDF

    Posted 07-Aug-2014 13:31
    Wanted to ask you a quick question in regards to how regulators view signing forms in Adobe Acrobat, signature protected? I want to add more signatures to our internal CAPA form and it would be best done on a PDF fillable form with electronic signatures.  Does anyone have any thoughts on this?  Thanks.

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    Ryan Gilmore
    Regulatory Affairs/Quality Assurance Director
    Hemo Bioscience, Inc
    Durham NC
    United States
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  • 2.  RE: Electronic Signatures in Adobe PDF

    Posted 08-Aug-2014 08:16
    We use Adobe e-signatures in our labeling approval process and it has passed muster in an inspection 2 years ago. Be sure to enable the "Reason for Signature" function and set the app to lock the signatures once applied.

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    Carroll Hoyle
    Sr. Global Regulatory Affairs
    BSN Medical
    Rutherford College NC
    United States
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    Original Message


  • 3.  RE: Electronic Signatures in Adobe PDF

    Posted 08-Aug-2014 10:54
    Hi Ryan

    I had a discussion with a notified body about this issue a while back and he even recommended this approach.

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    Guido Bloedorn
    Quality & Regulatory Affairs Leader, Medical Imaging
    PerkinElmer
    Walluf
    Germany
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    Original Message