ALCOA principle

ALCOA is a regulatory data-integrity framework requiring records in GxP-regulated manufacturing to be Attributable, Legible, Contemporaneous, Original, and Accurate — with the "+" extension adding Complete, Consistent, Enduring, and Available.

In depth

ALCOA and ALCOA+ are the FDA and EMA shorthand for what a trustworthy electronic record looks like. Attributable: you know who did it. Legible: humans and machines can read it. Contemporaneous: captured at the time of the action. Original: first recording (or a certified copy). Accurate: correct. ALCOA+ adds Complete, Consistent, Enduring, and Available. Azumuta is built to produce ALCOA+-compliant electronic batch records and audit trails by default: every action is signed by the operator, timestamped, and immutable.

See also

• Electronic batch record
• audits

Azumuta resources

• ALCOA principle and data integrity