Glossary
What ALCOA+ means for LLM outputs
The data integrity standard regulators already use, applied to the text an AI agent produces.
ALCOA+ is the data integrity standard that an LLM or AI agent output must be Attributable, Legible, Contemporaneous, Original, and Accurate, plus Complete, Consistent, Enduring, and Available. For regulated work it means each output is tied to a named person, recorded as it happened, kept in its unaltered form, and retrievable for an audit years later.
ALCOA+ came out of FDA and MHRA expectations for lab and manufacturing records. It predates the current wave of AI. When an LLM writes a deviation summary or an agent updates a batch record, that text is a GxP record, and the regulator applies the same nine attributes it has always applied. A model drafting the words does not change the rule.
The attribute that breaks first is Attributable. A clean paragraph from a model, with no author and no record of which version produced it, fails before anyone reads it. This is the same reason an AI audit trail logs every step and keeps a human accountable for the output. For the wider control framework around that, see GAMP 5 for AI and our work in regulatory affairs.
ALCOA+ is the data integrity standard that an LLM or AI agent output must be Attributable, Legible, Contemporaneous, Original, and Accurate, plus Complete, Consistent, Enduring, and Available. For regulated work it means each output is tied to a named person, recorded as it happened, and kept retrievable for audit.
The nine attributes, applied to AI output
- Attributable. A named person signs for the output, and the system records which model and prompt version produced it.
- Legible and Original. The output is readable and the first unaltered version is preserved, not silently overwritten.
- Contemporaneous and Accurate. The record is logged as the work happens and reflects what the agent actually did.
- Complete, Consistent, Enduring, Available. Nothing is dropped, the format holds over time, and the record can be retrieved for the full retention period.
Common questions
Does ALCOA+ apply to AI-generated records?
Yes. A regulator does not exempt a record because an LLM drafted it. The same nine attributes apply, so the output needs an author, a timestamp, an unaltered original, and an enduring, retrievable copy.
What is the hardest ALCOA+ attribute for LLM outputs?
Attributable. A model output with no named human behind it and no trace of which version produced it fails on the first attribute, which is why a human signs for the result and every step is logged.
15 min. 5-day written diagnosis. No deck.