Home › Forums › Signatures › FDA Provides Clarification on 21CFR11 for Third Parties

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    • July 20, 2021 at 7:57 am #4218
      Eldin RammellEldin 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 NishiharaMai 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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