Data Integrity: The Importance of a Quality Culture

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 generated to support the quality of manufactured products is both reliable and accurate.

Compliance violations involving data integrity have led to numerous regulatory actions by the FDA in recent years, including warning letters, import alerts, and consent decrees. In 2018 alone, the FDA issued 54 warning letters that had references to data integrity and data management deficiencies in pharmaceutical companies, 10 of which were in the United States. An analysis of 2018 warning letters by FDAzilla found that 45% of GMP-related warning letters issued to pharmaceutical companies based in the United States included a data integrity deficiency.

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