Glossary

Data must correctly represent what was observed. The platform enforces this via citation grounding on authoring agents and reviewer sign-off before promotion.

See also: ALCOA+, Citations

The FDA / MHRA data-integrity framework. Every regulated write on this platform carries the metadata needed to satisfy all nine pillars. See each pillar entry for what it means in practice.

See also: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available

Every record must identify who created it. The platform records created_by, signed_by, and a full provenance_event chain for every regulated write.

See also: ALCOA+, Provenance

Data must be retrievable on demand throughout the retention period. Inspection-ready exports are produced from the provenance store and signature events.

See also: ALCOA+

All data, including repeats and reanalyses, must be retained. The platform never deletes provenance rows; corrections are recorded as new events with links to the original.

See also: ALCOA+, Provenance

Records must follow the same sequencing and use synchronized, traceable timestamps. The platform timestamps every event in UTC (timestamptz) and orders by the database clock.

See also: ALCOA+

Records must be created at the time of the activity. Agent actions write provenance events synchronously; signatures capture the wall-clock signing time, not the action time.

See also: ALCOA+

Records must persist for the full regulatory retention period (often 25+ years). Provenance and signature rows are append-only and backed up off-site.

See also: ALCOA+

Records must be readable and permanent. Stored as structured JSON in Postgres with human-readable rendered views in the inspection package.

See also: ALCOA+

Records must be the first capture, or a verified true copy. Staging carries the original proposal; promotion produces a true copy bound to the signature.

See also: ALCOA+, Staging

The append-only log (provenance_event table) recording every regulated action: who, what, when, why, with which model and prompt version. Powers ALCOA+ and inspection exports.

See also: ALCOA+, Attributable