Grimoire One — a compliance engine
§ 01·The regulations
two frameworks, one engine
§ 02·Method
the law, as a program
Regulatory text is compiled into Prolog. Your evidence asserts the facts, and the engine derives the verdict — deterministic, repeatable, and impossible to fudge.
Evidence documents are asserted as Prolog facts; the regulation, compiled as a rule, is satisfied term by term; the engine derives that the batch is compliant.
§ 03·Evidence
proof, not promises
Each audit and classification produces a report: the verdict, its basis, the underlying logic, and timestamps.1 Export it and move on.
01Classification basis
02Validation results
03Annex IV sections
04The Prolog itself
ACME Hiring Model v2.3
high-risk · Reg (EU) 2024/1689
1.The report records which clauses fired and in what order — the same derivation an inspector could reproduce by running the program themselves.
§ 04·In numbers
0+
FDA warning letters analyzed
0+
Regulatory citations per letter
0%
Title 21 CFR section coverage
§ 05·Procedure
scroll — the derivation unfolds
Four stages: first, the statute — 21 CFR § 211.188 requires reviewed and approved batch records, complete records, and the signature of the person performing each step. Second, that requirement is compiled into an executable Prolog rule, one clause per obligation. Third, your evidence — batch record, review log, record index — is asserted as facts. Fourth, the engine derives the verdict, compliant, and exports the derivation as an evidence report with the clauses that fired and timestamps.
Every audit begins with the regulation itself — the paragraph an inspector would read aloud. Grimoire One treats that text as the source of truth, phrase by phrase.
“Batch production and control records shall be prepared for each batch… reviewed and approved… and shall include complete records of, and the signatureof the person performing, each significant step.”
21 CFR § 211.188 — the source of truth
Each obligation becomes a clause of an executable Prolog rule. The underlined phrases reappear, one to one, as the terms of the program — the law, now machine-checkable.
% 21 CFR § 211.188, compiled
compliant(B) :-
signature(B),% the signature of the person
reviewed(B),% reviewed and approved
records_complete(B).% complete records
one clause per obligation — nothing paraphrased away
Your documents become facts. A batch record, a review log, a record index — each is asserted into the program as ground truth. No scoring, no judgment calls.
% facts asserted
→ signature(batch_42).
→ reviewed(batch_42).
→ records_complete(batch_42).
The engine runs the query and the verdict follows — pass, fail, or escalate, with the exact clauses that fired. Every audit exports the derivation as a report an inspector could reproduce.
?- compliant(batch_42).
true. ⊢ compliant ∎verdict · proven
Evidence report — CFR-211-188
the clauses that fired · timestamps · exportable
the verdict follows from the evidence — not from anyone's say-so.
Sampling tells you what you checked. Formal verification tells you what's true — across every requirement, every time.
§ 06·Questions
Checklists record opinions. Grimoire One compiles the regulation into a Prolog program and derives a verdict from your evidence — every pass or fail is backed by the exact rules that fired.
FDA Title 21 CFR (audits, Part 11, warning-letter analysis) and the EU AI Act (Regulation 2024/1689) today, with a shared engine designed to take on more.
Yes. Every classification and audit produces a report containing the verdict, its basis, the underlying Prolog, and timestamps — ready to hand over.
No. You answer plain-language screening forms (and can autofill them from documents). The logic runs underneath.
Start with a single CFR audit or classify an AI system against the EU AI Act — and walk away with proof.