Data Integrity Violations in USFDA-Approved Pharmaceutical Industries
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This book explores the crucial role of data integrity in the pharmaceutical industry, particularly under the regulatory lens of the U.S. FDA. Covering the evolution of data governance principles like ALCOA and ALCOA+, it analyzes real-world case studies including major violations by industry leaders like Ranbaxy. The book examines FDA warning letters, 483 observations, and the statistical rise in data integrity breaches globally, especially in India and China. It highlights the consequences of violations - from product recalls to import bans - and presents actionable remediation strategies for...
This book explores the crucial role of data integrity in the pharmaceutical industry, particularly under the regulatory lens of the U.S. FDA. Covering the evolution of data governance principles like ALCOA and ALCOA+, it analyzes real-world case studies including major violations by industry leaders like Ranbaxy. The book examines FDA warning letters, 483 observations, and the statistical rise in data integrity breaches globally, especially in India and China. It highlights the consequences of violations - from product recalls to import bans - and presents actionable remediation strategies for maintaining compliance. Designed for professionals and scholars, this work serves as a vital guide to understanding how trustworthy data underpins public health, regulatory success, and corporate reputation.
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