ALCOA+ Demystified: The Ultimate Framework for Data Integrity in Pharmaceutical Compliance
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ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) is a globally recognized framework mandated by regulatory bodies like the FDA, WHO, and EMA to ensure data integrity in the pharmaceuticals manufacturing industry. Originating from the FDA’s 1990s ALCOA guidelines, it evolved into ALCOA+ in the 2010s to…