Regulatory Open Forum

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  • 1.  Scanned (electronic) records

    Posted 20-Oct-2011 11:04

    Has anyone had any experience with FDA questioning the use of scanning documents for storage ?,particularly the aspect of "validating" the scanning equipment to create a legally accepted facsimilie of the original.
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    Steven Howell
    Senior QA Director
    FlexMedical
    Chula Vista CA
    United States
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  • 2.  RE:Scanned (electronic) records

    Posted 20-Oct-2011 12:08
    There is a Draft Guidance from the FDA on the topic of electronic records and electronic signatures. 


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    Marc Sanchez
    Attorney and Consultant
    Atlanta GA
    United States
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    Original Message


  • 3.  RE:Scanned (electronic) records

    Posted 20-Oct-2011 13:32
    Steven,

    FDA does periodically inquire and evaluate manufacturers systems that include electronic signatures and electronic records.  As mentioned, there is a guidance document that gives insight into the expectations http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072322.pdf.  In addition the compliance guidebook talks about what to review pertaining to electronic signatures or electronic records.

    There is no specific requirement for validation of the scanning equipment, however, there could be a validation of the process.  We have found that it is important to have SOPs in place the detail how electronic records are generated, how they are verified (after scanning), and how they are periodically checked (audits).  In my experience, I did have an inspector ask a specific question related to scanned documents.  Basically, we had to support that once the document was scanned, we had to have the mechanism and verification that the scanned copy was an exact duplicate of the original.  He had not really concentrated on the scanning equipment itself.

    The entire process includes finalization of the hard-copy, utilizing the scanning equipment to generate the electronic version, and then storage of the electronic record.  Make sure that you also have an electronic record retention policy that includes back-up and restoration of those files; this should also be validated.

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    Richard Vincins RAC
    Vice President, QA
    Emergo Group Inc
    Austin TX
    United States
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    Original Message