Reply To: FDA Guideline 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