Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA) defines foundational data integrity principles recognized by the FDA and global regulators.
These principles ensure that records can be traced to a responsible individual, are readable, recorded in real time, preserved in original form, and free from error. ALCOA standards apply to source documents, electronic systems, and regulatory files. Expanded into ALCOA+, the framework also includes completeness and consistency. Strong adherence supports inspection readiness and defensible research outcomes.