ALCOA began as a five-word test for good records: data must be Attributable (who did it and when), Legible (readable for its whole life), Contemporaneous (recorded at the time of the activity), Original (the first capture, or a certified true copy) and Accurate (correct, with changes documented). The “plus” adds Complete (nothing missing, including repeats and failures), Consistent (in the expected sequence, with reliable time stamps), Enduring (durable for the retention period) and Available (retrievable for review and inspection).
Why it matters in GMP
ALCOA+ is the vocabulary of data integrity guidance from the FDA, MHRA, WHO and PIC/S. When an inspector questions a record, they are usually asking which of these attributes it fails: a shared login breaks attributability, a result typed up later breaks contemporaneity, a deleted failing injection breaks completeness.
- Attributable — unique user accounts, no shared logins, e-signatures linked to the person.
- Contemporaneous and consistent — trusted server time stamps, not user-entered dates.
- Original and complete — corrections that never overwrite the first entry.
- Enduring and available — secure retention and fast retrieval for the inspector.
How Swat iQua Suite handles it
Swat iQua Suite builds these attributes into every module. Each change is written together with its audit trail entry in one transaction, with the user, the site, a server time stamp, the old and new values and a mandatory reason. Corrections supersede and never overwrite, so the original value stays visible. Raw data files are stored with a SHA-256 checksum, and controlled prints and exports are logged.