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    Please Note This forum exists for community support for the Mango product family and the Radix IoT Platform. Although Radix IoT employees participate in this forum from time to time, there is no guarantee of a response to anything posted here, nor can Radix IoT, LLC guarantee the accuracy of any information expressed or conveyed. Specific project questions from customers with active support contracts are asked to send requests to support@radixiot.com.

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    Is Mango compatible with 21 CFR Part 11 ?

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    • M
      Malaguena last edited by

      Hi All,

      Is Mango compatible with 21 CFR Part 11 ?

      21 CFR Part 11 : https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

      Thanks!

      cwangv 1 Reply Last reply Reply Quote 1
      • cwangv
        cwangv @Malaguena last edited by

        @nurr
        I am guessing the answer is no since Mango does not enforce annotation for user actions. that is one of requirements of fda.

        1 Reply Last reply Reply Quote 0
        • M
          Malaguena last edited by

          @cwangv
          Actually, Mango logs audit events for edit, delete, create user actions.

          1 Reply Last reply Reply Quote 0
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