Vol. 7, Issue 2, Part J (2025)

Data integrity has become a cornerstone of pharmaceutical quality systems, directly influencing patient safety, regulatory compliance, and product quality. As pharmaceutical operations increasingly rely on both manual and electronic data, ensuring the accuracy, consistency, and reliability of information throughout its lifecycle is critical. Regulatory authorities such as the US FDA and EMA emphasize strong data governance through frameworks like cGMP, 21 CFR Part 11, and EU Annex 11. Central to these requirements are the ALCOA and ALCOA+ principles, which define good documentation practices. This article presents a concise yet comprehensive overview of data integrity concepts, principles, classifications, risks, regulatory expectations, and modern digital approaches, highlighting strategies to strengthen pharmaceutical quality systems and sustain regulatory trust.