ALCOA+ - AtlaSent

ALCOA+ is the data-integrity vocabulary cited by FDA, EMA, WHO, MHRA, and PIC/S. It describes what “good data” looks like in a regulated environment.

Mapping

Principle	Definition	AtlaSent primitive
A — Attributable	Who did what, when	`actor.id` in every evaluation; human overrides name the user; API key hash identifies the service.
L — Legible	Human-readable	JSON entries; Console viewer; exported bundle is plain JSONL.
C — Contemporaneous	Recorded at time of event	Audit entry is atomic with the decision — no “write later.”
O — Original	Not a copy	Audit chain is the system of record for authorization decisions.
A — Accurate	Free of error	Server-generated entries; hash-linked to prevent tampering.
+C — Complete	All data, including meta	Policy ID, version, rule, reason, permit ID all in the entry.
+C — Consistent	In sequence	Chain order is preserved; `prev_hash` encodes the order.
+E — Enduring	Preserved as long as needed	Export is self-contained, verifiable offline, no dependency on AtlaSent uptime.
+A — Available	Retrievable on demand	Console query + API pagination; export for air-gapped review.

Where ALCOA+ ends and your SOPs begin

AtlaSent’s audit chain is ALCOA+ for the authorization decision. The underlying record (the EHR, the batch record, the trial data) still lives in your system of record — your own SOPs have to ensure ALCOA+ for that data. What AtlaSent adds is a tamper-evident authorization trail that links the two.