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  • 1.  Electronic Signature

    Posted 18-Nov-2021 09:58

    Hello,

     

    Could you please let me know if the following requirement (Part 11, Subpart C- electronic signature 11.100 general requirements) must be performed?

     

    (1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.

     

     

    Thanks in advance.

     

    Kind regards,

    Elham A. Mirzanagh

     

     

     

     

     

     

     

     

     

    Dr. Elham Abdollahi Mirzanagh

     

    Consultant

    +491731872593

    Elham.Abdollahi-Mirzanagh@gxp-cc.com

     

     

     

    GxP-CC GmbH: Europaallee 33 - 67657 Kaiserslautern - Germany
    GxP-CC Inc.: 15757 Pines Blvd Suite 713 - Pembroke Pines, FL 33027 - USA 

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    . . . . . . . . . . . . . . . . . . . . .

    Best Regards / Mit freundlichen Grüßen

    Elham Abdollahi-Mirzanagh 
    Consultant

    +49 173 1872593

    Elham.Abdollahi-Mirzanagh@gxp-cc.com


    We Dare, We Share, We Care, We always Deliver! 
    Find us online | LinkedIn

    GxP-CC GmbH: Europaallee 33 - 67657 Kaiserslautern - Germany
    GxP-CC Inc.: 1560 Sawgrass Corporate Parkway, 4th Floor - Sunrise, FL 33323 - USA 

    Handelsregister/Commercial Register: HRB 32899 Registergericht: AG Kaiserslautern


    Geschäftsführung/Executive Management: James R. Francum

    Zusatzinformation GxP-CC-GmbH/ Extra Info GxP-CC-GmbH:
    Handelsregister/Commercial Register: HRB 32899 Registergericht: AG Kaiserslautern Umsatzsteueridentifikationsnummer gemäß § 27a Umsatzsteuergesetz/VAT Registration number: DE290218167 Telefon/Telephone: +49 800 49 72 246 – E-Mail: info@gxp-cc.de

    Diese E-Mail enthält vertrauliche und/oder rechtlich geschützte Informationen. Wenn Sie nicht der richtige Adressat sind oder diese E-Mail irrtümlich erhalten haben, informieren Sie bitte sofort den Absender und vernichten Sie diese Mail. Das unerlaubte Kopieren sowie die unbefugte Weitergabe dieser Mail ist nicht gestattet.

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  • 2.  RE: Electronic Signature

    Posted 18-Nov-2021 15:33
    Hi Elham.

    This one I think is pretty straight forward and I don't expect that you will get many differences of opinion on this one.  This is required.  The general basis of this includes:

    1. The fact that this is part of the regulations (note that the CFR is a legal requirement).
    2. The use of the verb "shall" implies a mandatory requirement.  In fact, one of the definitions of the term "shall" is "must; is obliged to".

    Hope this helps.

    ------------------------------
    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
    ------------------------------

    Original Message


  • 3.  RE: Electronic Signature

    Posted 19-Nov-2021 04:30
    Edited by Richard Vincins 19-Nov-2021 04:31
    Elham,

    The specific requirement you are citing is if you are sending in electronic signatures directly to the FDA such as for electronic submissions.  21 CFR 11 is well mis-understood because this is a regulation generated for how FDA requires electronic signature and data in relation to multiple aspects.  Reading through 21 CFR 11.1 defines the scope and has a nice blanket statement, 'under any records requirements set forth in agency regulations.'  Also this applies to all of FDA, not just one branch like drugs or medical devices.  Many companies apply these concepts and rules internally in order to conform with the regulation concerning electronic records managed during inspections.  If you are just using electronic signatures internal within your company, you do not need to send in certification to FDA.  Though you need to comply with 21 CFR 11.100(b) to confirm identity of the individual, so having wet signature and confirmation of identity on a record is needed.  If the organisation is making as an example an eCTD to the Agency with electronic signatures, than this would be needed to support the wet signature to the electronic signature.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: Electronic Signature

    Posted 25-Nov-2021 08:39
    Thank Richard for more elaboration.


    Best,
    Elham

    ------------------------------
    Elham Mirzanagh
    Consultant
    Kaiserslautern
    Germany
    ------------------------------

    Original Message


  • 5.  RE: Electronic Signature

    Posted 25-Nov-2021 08:37
    Thank you Victor for you reply.

    This means, sending once a letter to FDA or per company, that they are using legally binding signatures?

    Best,
    Elham

    ------------------------------
    Elham Mirzanagh
    Consultant
    Kaiserslautern
    Germany
    ------------------------------

    Original Message


  • 6.  RE: Electronic Signature

    Posted 19-Nov-2021 05:31
    This certification is for the entire company and only needs to be done once.  It should be signed by someone who has responsibility for the entire organisation - and I have seen it signed by the head of Regulatory.
    Proof of this certification is required by the US-FDA in order to obtain an ESG account for sending electronic submissions to the US-FDA.

    ------------------------------
    Donald Palmer
    Sr. Regulatory Affairs Director
    United States
    ------------------------------

    Original Message


  • 7.  RE: Electronic Signature

    Posted 25-Nov-2021 08:40
    Thank Donald for your input.

    Best,
    Elham

    ------------------------------
    Elham Mirzanagh
    Consultant
    Kaiserslautern
    Germany
    ------------------------------

    Original Message


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