What is Data Integrity? Data integrity is the maintenance of, and the assurance of, data accuracy and consistency over its entire life-cycle and is a critical aspect to the design, implementation, and usage of any system that stores, processes, or retrieves data. Data integrity is a key approach in the pharmaceutical quality control system. ALCOA is (Attributable, Legible, Contemporaneous, Original, and Accurate) was introduced in the 1990s for ensuring the pharma industry as a framework for data integrity and Good documentation practice (GDP). Then further introduced ALCOA plus is (Complete, Consistent, Enduring and Available) Currently used by the FDA, WHO, PIC/S, and GAMP. So overtime periods, data integrity concepts expand from ALCOA to ALCOA plus for ensuring data security and integrity ( data protection) are observed and maintained. ALCOA+ ALCOA has five basic principles (Attributable, Legible, Contemporaneous, Original, and Accurate) to stop data integr...
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