FDA Guideline for Data Integrity

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  • October 4, 2023 at 3:03 am #4561
    aid
    Participant

      What are the FDA guidelines for data integrity?

      November 8, 2023 at 8:18 am #4692
      Pharma Digests
      Pharma Expert

        Requirements with respect to data integrity in 21 CFR parts 11, 211 and 212:
        – 21 CFR PART 211.68
        – 21 CFR PART 211.100
        – 21 CFR PART 211.160
        – 21 CFR PART 211.180
        – 21 CFR PART 211.188
        – 21 CFR PART 211.194
        – 21 CFR PART 212.110
        – 21 CFR PART 212.60
        – 21 CFR part 11

        November 28, 2024 at 1:32 am #6530
        aid
        Participant

          What are the common DI issues from FDA point of view?

          December 9, 2024 at 12:17 am #6575
          Pharma Digests
          Pharma Expert

            Most common DI issues in Pharma:
            1. Backdating of Postdating
            2. Difference between raw data and recoded data
            3. Data hidden
            4. Inconsistencies in Data
            5. Access by Unauthorized Individuals etc.

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