Maintaining Data safety and accuracy through Data Integrity (DI): A Comprehensive Review

Abstract

In the pharma industry, data integrity (DI) is essential to make sure that the final products meet all the relevant quality requirements. It is the essence of all the methods of maintaining and ensuring the accuracy and continuity of data over its entire life cycle. DI is the most popular subject in the pharma industry. It gives precise, reliable and uniform data throughout its entire life cycle. This includes good documentation practices (GDP) that restrict the movement, deletion, copying or editing of data. Implementation of its principle will directly reflect the quality of the product. DI must comply with ALCOA+++ according to Food and Drug Administration (FDA) and Medicines and Healthcare Products Regulatory Agency (MHRA) guidelines. ALCOA+++ represents Attributable, Legible, Contemporary, Original, Accurate, Complete, Consistent, Enduring, Available. As outlined in numerous guidance and regulations, DI is over-critical to regulatory submissions. This article describes the concept, importance, regulatory requirements, data life cycle, types and principle ALCOA+++, DI-related risks, issues and its various solutions.