Category: Data Integrity

  • An Analysis of 2019 FDA Warning Letters Citing Data Integrity Failures

    An Analysis of 2019 FDA Warning Letters Citing Data Integrity Failures

    By Mohammed Raihan Chowdhury Data integrity is a fundamental aspect of ensuring the quality, safety, and efficacy of pharmaceutical products. It refers to the completeness, consistency, and accuracy of data throughout the data lifecycle. Data integrity failures can compromise the reliability of data and lead to serious consequences for patients, manufacturers, and regulators. Therefore, the…