ALCOA is the shorthand FDA uses in its data integrity guidance: records should be attributable, legible, contemporaneously recorded, original (or a true copy) and accurate. ALCOA+ adds complete, consistent, enduring and available. Some guidance extends the list further, often called ALCOA++, and the EU's 2025 draft revision of Chapter 4 refers to these principles for document integrity.
Why it matters for labeling
Labeling records are GMP records. The approved master, review comments, comparison results and approvals all need to be attributable to a person, readable, recorded at the time, original or a verified true copy, and accurate. Converting artwork between formats or re-keying text can create copies that no longer match the original, so how copies are made and checked matters.
Common mistakes
- Approvals recorded without a named individual
- Screenshots or printouts kept as the original instead of the source file
- Edits made after sign-off without a record
- Records that can't be retrieved for the full retention period