Data Integrity Violations in the Pharmaceutical Industry and Regulatory Measures

Data integrity is critical to the pharmaceutical industry, ensuring the reliability, accuracy, and consistency of data generated throughout the product lifecycle. However, data integrity violations have been a growing concern, potentially compromising pharmaceutical products’ safety, efficacy, and quality. This systematic review aims to provide an overview of data integrity violations in the pharmaceutical industry and examine the regulatory measures implemented to address this issue. Through a comprehensive analysis of literature, this review highlights the root causes of data integrity violations, the impact on patient safety and public health, and the regulatory landscape governing data integrity in the pharmaceutical industry. It is essential for pharmaceutical companies to prioritize data integrity as an integral part of their operations, from research and development to manufacturing, clinical trials, and post-marketing surveillance. By implementing robust data integrity practices and adhering to regulatory requirements, pharmaceutical companies can protect patient welfare, maintain regulatory compliance, and sustain public trust in the industry.