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Electronic Signatures

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  • Bert
    21/06/2018 09:11
    Dear All, Can you please confirm that if we capture signatures electronically on monitoring visit reports, these signatures have to meet the requirements of 21 CFR part 11, even if these records are not submitted to FDA? And if so, we need to send a certification to FDA stating that our organisation is using e-signatures? Many thanks, Bert
  • Matt Jones - Chair DIGIT Committee
    21/06/2018 09:45
    Dear Bert, If you are using e-signatures you should always send the attestation to the FDA (The address is on current 21 CFR Part 11 document). Even though the scope and guidance documents states that there are priorities for enforcement of 21 CFR part 11, it is strongly recommended that any documentation required by section 8 of ICH GCP and within the monitoring section 5.18.6 has a robust signature mechanism, they would expect the same level of confidence in the e-signature as a wet signature in the paper process. Other regulators including EMA and MHRA would also look for equivalence to the original process, so it wouldn't only be the FDA looking for the requirement of having a valid and appropriate electronic signature. Best wishes Matt
  • bert
    21/06/2018 12:02
    Thanks a lot Matt. That's clear :-).
  • elma asheley
    03/01/2019 04:25
    Very helpful reply by Matt
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