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Data Integrity for Regulated Labs
About this paper
Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of
human and veterinary drugs, biological products, and medical devices. As such, the FDA’s expectation is that
all data which is submitted to the Agency is both reliable and accurate. This white paper outlines all of the key expectations and guidance by the FDA which should act as a guidepost for lab managers and informatics professionals.