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Electronic Signatures

Discussion in 'EU Medical Device Regulations' started by Amy G, Oct 19, 2018.

  1. Amy G

    Amy G New Member

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    I am trying to find details within either the new MDR or 13485 in regards to documentation and signatures.

    Historically we have always printed signed and scanned documents for all, however as we cover many sites can we look at introducing electronic signatures? Would we have to have validated?
     
    Amy G, Oct 19, 2018
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  2. yodon

    yodon Well-Known Member

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    I'm not aware of anything on the device side that talks to e-signatures (i.e., comparable to the US 'Part 11') regulations. Eudralex Annex 11 (https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf) was written for the pharma & vet side but might be something to consider.

    Validation would give you support for claims of signature validity. In the absence of specific guidance, you may want to consider both Part 11 and Annex 11 and define your strategy. You WOULD be using a computer system to apply the signature so that would drive validation anyway.
     
    yodon, Oct 19, 2018
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