Review on Data Integrity Based on The Principle of ALCOA

Data integrity is the cornerstone of 21 CFR Part 11, which was published in the United States, and is essential for enforcing rules. FDA officials wished to guarantee that accurate data was collected by the pharmaceutical industry along the course of the medication’s lifespan. Even if this information becomes one of the most valuable assets of any company, if they are not honest, they are not very useful to prevent data from being altered, copied, or transferred, it also entails using appropriate documentation practices. Regarding data integrity, all original records— whether stored electronically or on paper—including source data and metadata are referred to as data. Several regulatory agencies, such as the USFDA, Health Canada, and EMEA, recommended ALCOA to guarantee the accuracy of the data (Attributable, Legible, Contemporaneous, Original, and Accurate.