FDA Guideline for Data Integrity

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      October 4, 2023 at 3:03 am #4561

      What are the FDA guidelines for data integrity?

        PharmaDigests.com
        November 8, 2023 at 8:18 am #4692

        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

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