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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…
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Going Paperless: The Benefits of E-Document Management Systems in Pharmaceutical Industry
The pharmaceutical industry is highly regulated and complex, with strict requirements for document management. Paper-based document management is no longer feasible in this environment, as it is inefficient, error-prone, costly, and challenging to comply with regulations. On top of everything, paper documentation causes huge environmental pollution. Every year, $25-35 billion is spent in the U.S.…