FDA Electronic Records & Electronic Signatures. The same gate attaches whatever you're building — a reviewer agent reads the rule, your code, and your tests, and blocks the merge if a requirement is missing.
FDA enforcement runs from 483 observations to Warning Letters, import alerts and consent decrees — the cost is a halted submission or a blocked product.
Part 11 findings commonly appear in Warning Letters tied to missing audit trails and uncontrolled electronic signatures; a consent decree can suspend manufacturing entirely.
The risk is rarely ignorance of the rule — it's the gap between knowing it and enforcing it on every pull request. Electronic records with no tamper-evident audit trail, e-signatures without identity controls, and no validation of the system that produces the records — each is a pattern a reviewer can catch in the diff, before it reaches production. That gap is what the fda-reviewer + glp-glab-reviewer enforce validation + audit-trail gates closes.
GreatCTO detects your project's archetype, overlays the matching reviewer agent, and attaches the 21 CFR Part 11 gates. The reviewer reads the regulation text, your code, and your tests, then emits a verdict per requirement — with a diff if anything's missing.
Stack signals, manifests, and README keywords identify the project type. 21 CFR Part 11 gates attach when the code paths that carry the obligation are in scope.
The reviewer prompt encodes each requirement above as a check. When a PR touches a relevant code path, the gate fires with the specific check that matters.
Each gate decision is logged to .great_cto/gates.log with timestamp, reviewer, verdict, and rationale. Auditors get a tidy CSV; no scramble at audit time.
When an auditor flags something, the lesson promotes to ~/.great_cto/decisions.md after the 3rd similar finding and ships in the next project's Step 0.
21 CFR Part 11 doesn't care what you're building — and neither does the gate. The same enforcement attaches whether your project is a fintech API, a healthcare app, a marketplace, an MLOps pipeline, or an internal tool:
It does not certify you. 21 CFR Part 11 compliance requires human accountability — a sign-off, a review, in some cases an external auditor. GreatCTO ships the evidence; you still own the attestation.
It does not substitute legal review. The reviewer encodes commonly accepted readings of the regulation, not your specific jurisdictional interpretation. For high-stakes cases, lawyer involvement is still load-bearing.
It does not eliminate gaps in the requirements list. The list above is the surface area covered programmatically. Override the reviewer prompt in agents/ for your specifics.
Every box on the diagram is a clickable link to the agent's source on GitHub.
A pack rollout with gates auto-wired. Timeline, costs, artifacts.
The fda-reviewer + glp-glab-reviewer enforce validation + audit-trail gates prompt is auditable. Read it, override it, fork it.
$ npx great-cto init
Free, MIT, runs locally. The reviewer agent ships with the npm package — no SaaS portal, no compliance-vendor lock-in.
Startups have often reached out to me with the same problem: their team could ship a regulated feature in days, but the compliance setup aro
Not a complaint about lawyers. A breakdown of where the six weeks actually go, and which parts of it are mechanical.
Per-feature, per-MVP, per-quarter numbers. Hardware ratios, runway math, and the honest places where the savings stop.
Regex vs LLM-based archetype detection, the false-positive count, and why I keep rejecting the obvious fix.