The fastest way to keep AI-generated code compliant

A dead simple, drop-in replacement: real-time regulatory checks and one-click fixes as you build.

POST /v1/analyze → violations → POST /v1/fix-violation

No credit card required.

Built for regulated teams
FDA Part 11 GxP CSV Life sciences Healthcare
Real-time
analysis

Checks run as you type. No “Analyze” button—violations surface instantly.

One-click
fixes

Apply certified patterns per-rule or fix all. Audit trail, auth, integrity—inline.

3 modes
enforcement

Advisory, Enforced, or Blocking. Match to dev, staging, or production.

Meet teams shipping compliant code

Read story

Life sciences team cuts compliance review time by 60% with RegEngine

“RegEngine was such a low-effort way for us to keep AI-generated code compliant. We ship faster and pass audits with confidence.” — Compliance lead, regulated healthcare
Read story

Healthcare app achieves Part 11 compliance in the editor before merge

Meet our customers

Compliance, but actually in your editor

We fill the gap between “AI wrote it” and “auditors will see it”: see violations, apply fixes, and ship code that meets FDA 21 CFR Part 11 and GxP.

  • Spot missing audit trails, user attribution, and data-integrity gaps before merge.
  • Fix violations with certified patterns—append-only audit log, validated data update, e-signature.
  • Get inline fixes and one-click “Fix all” so PRs stay compliant.

RegEngine cuts compliance risk before code ships

Nobody wants to find Part 11 gaps in production. Fix issues while code is still in the editor.

■ 01

Analyze as you generate

RegEngine evaluates code against FDA Part 11 (and more), surfaces violations in real time—no separate audit step.

■ 02

One-click remediation

Each violation gets a suggested fix. Apply per-rule or fix all. Code updates with certified compliance patterns.

■ 03

Enforcement you control

Advisory (warn), Enforced (must fix), or Blocking (no ship). Match mode to environment.

Deploying with RegEngine versus the rest

Our product comes with batteries included and costs less than manual review, and far less than shipping without compliance checks.

Read docs

Features

RegEngine Manual review No checks
Real-time analysis
One-click fixes
Certified patterns Varies
API + IDE integration

Built for regulated workflows

Part 11
Rules covered
Certified
Compliance patterns
API + Cursor
Integrations

Start with the demo or plug in the API

Run the demo with sample healthcare code, or call /v1/analyze and /v1/fix-violation from your IDE.

Try the demo