White Paper – Best Practice for Data Integrity Assessments

Best Practices for Conducting Data Integrity Assessments

In order to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical
devices, the FDA has stepped up its regulatory focus on data integrity significantly over the last several years.
From the moment data is generated, and extending through to the end of its life cycle, the FDA considers data
integrity to be critical to the manufacture of high quality and safe medications and devices. The FDA’s expectation
is that all data involved in the production of FDA regulated products is both reliable and accurate.

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