About HIVE — how this works, and its limits
Prototype. Two product records are seeded so the flow can demonstrate Principle 1 — nothing already on a record is asked for. Smart Intake calls Claude to read your description and pre-answer what it can. It pre-answers questions of fact only. Questions tagged Judgement or Memory are never pre-answered: a scientific call and a company's own regulatory history are not things a language model should assert on your behalf. Classification runs on the deterministic rule base, not on the model. No confidence percentage is shown, because on a table lookup there is nothing for one to mean.European Union and United States (FDA) in this build. An earlier US module was withdrawn because it reused the EU annex as its own routing taxonomy and kept leaking EU tier labels into screens that were never built with jurisdiction in mind. It has been rebuilt from scratch as a standalone module: its own change-taxonomy, browsed and searched on its own terms, classified by the risk the applicant assesses against four statutory reporting categories under 21 CFR 314.70(a) — never by looking up an entry from another jurisdiction and translating it. GCC remains withdrawn: no GCC taxonomy has been built.
The loop closes here. Closed cases, with the judgements made in them, persist in a shared archive and are consulted before any Memory question is asked. The archive can establish that something exists — a protocol, a prior case, a determination already made. Whether it applies to this change stays a person's call, so the question is informed, never answered. That is the apex of the knowledge pyramid, and the only layer of the architecture a competitor cannot copy, because it is not knowledge about the world — it is knowledge about one organisation's history.