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21 CFR Part 11 Electronic Signatures scanned

Discussion in 'Qualification & Validation (Also 21 CFR Part 11)' started by binnie, Jun 5, 2020.

  1. binnie

    binnie Member

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    The scanned electronic signature is acceptable to kept as electronic record?
    example, the report has needed to be signed by 3 approvers.
    1st person sign using electronic signature after that second person print out and sign manually then scanned and send to third person. third person sign using electronic signature. After that the report has been kept as electronic record in database. in this example, in electronic record , 1st person electronic signature is scanned one.
    i would like to know this is acceptable as electronic record under FDA regulatory?
     
  2. yodon

    yodon Well-Known Member

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    Wow, that's an, um, interesting process. Why wouldn't everyone e-sign?

    First, I'm not completely sure what you mean by "1st person e-signature is scanned one." An e-signature cannot be scanned. An e-signature is data carried with the e-record (the data must include who signed, what the signature means, & when it was signed and the data must be retrievable).

    I am sure that what you describe would certainly result in more interest and scrutiny by the inspector. The bottom line is that you have to be able to demonstrate signature integrity. With "wet ink" signatures (and signatures captured electronically through use of a stylus or finger), the individual's signature is unique (discounting forgery) and thus can be considered to have integrity. Integrity of an e-signature can only be demonstrated through control of credentials and the ability to produce the signature data as described above. If you can somehow show all that with the process you describe, you should be in a defensible position. When you mention "1st person e-signature is scanned one," though, I suspect it's non-compliant.
     
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  3. binnie

    binnie Member

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    thanks for your answer... yes all e-signature is included name date and time.... what i mean for "1st person e-signature is scanned one" is that when the second person printed out as paper and scanned back to electronic record, i consider 1st person e-signature become scanned one. not sure my interpretation is correct? i would like to know whether 1st person e-signature is still valid? can we accept such kind of e-record.
     
  4. yodon

    yodon Well-Known Member

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    If an inspector walked in today, picked up that document, and asked for evidence that all 3 signatures were legitimate, what would you show? Obviously for the "wet ink" signed on the signature is sufficient (since the signature is unique). Can you present controlled material showing who signed, when signed, and what the reason of the signature was? If so, then that test is passed. There's still the question of validating the application and ensuring all proper controls but that's another story.
     
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  5. PERFEQTA

    PERFEQTA New Member

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    Along with electronic signatures, per FDA Title 21 CFR Part 11, and all of its sub-parts, GxP organizations use PERFEQTA to handle their processes. From document control, CAPA, equipment management, maintenance and calibration, in-process quality control, and hundreds of apps and dashboards, PERFEQTA helps GxP operations control their process better and meet quality standards with ease.
     

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