FDA Provides Clarification on 21CFR11 for Third Parties

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    • July 20, 2021 at 7:57 am #4218
      Eldin Rammell
      Keymaster

      The FDA have provided some clarification on the applicability of 21CFR11 for third parties e.g. eTMF vendors, training companies, software companies, document storage companies etc. The Q&A document can be found on the Resources page or a direct link here.

    • August 1, 2021 at 7:44 am #4227
      Mai Nishihara
      Participant

      Dear Eldin

      Thank you for posting the document.
      Watching your session online, I looked forward to having some guidance from FDA.
      The attached email you shared really helps me to get a clear picture.

      Warm Regards
      Mai

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