FDA Guideline for Data Integrity
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Tagged: Data Integrity, FDA
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