ALCOA++

ALCOA++ is the foundational acronym for Data Integrity in the regulated pharmaceutical and life sciences industries (cGMP). It stands for Attributable, Legible, Contemporaneous, Original, and Accurate. The “++” represents the extensions: Complete, Consistent, Enduring, and Available. Adherence to ALCOA++ is non-negotiable for all data—paper-based or electronic—used for regulatory submissions and batch release decisions. It guides the design of computerized systems, validation protocols, and Data Governance policies to ensure data reliability, especially as the industry adopts AI models and other Advanced Manufacturing Technologies (AMT).