ISSN : 2663-2187

An Overview Of Data Integrity in Pharmaceutical Industry

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Ashish S. Jain, Sayali.S. Shelke, Vaishali Jadhav, Sunita Gagare, Aditi Vitthal Sawant, Divya kalu shirsath, EmadKhan, Sanid Hadal
» doi: 10.48047/AFJBS.6.12.2024.4448-4458

Abstract

Data integrity is the cornerstone of 21 CFR Part 11, which was created in the United States, and is essential for implementing rules. FDA officials sought to guarantee that the pharmaceutical industry collected accurate data across the course of a medication's lifecycle. Even while this data grows to be one of the most valuable resources for any company, if it is not reliable, it is not very useful. Accuracy and original data boost the likelihood of stability and performance in an organization. Data integrity is the extent to which all data are complete, accurate, and consistent during the course of the data's life cycle. In order to prevent data from being altered, copied, or transferred, it also entails using appropriate documentation practices. When discussing data integrity, "data" refers to any original records—whether stored electronically or on paper—including source data and metadata. Many regulatory agencies, such as the USFDA, Health Canada, and EMEA, recommended using ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) to guarantee data integrity.

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