AI writes the code.
RegEngine keeps it compliant.
Real-time regulatory checks and one-click fixes for AI-generated code.
Enforce FDA 21 CFR Part 11, CSV, and GxP as you build—not after the fact.
Manual compliance review doesn’t scale
AI writes code fast; audits and remediation happen later. Regulators care about electronic records, audit trails, and access control—catch gaps before they ship.
Audit-after-the-fact
Finding Part 11 gaps in production is costly and risky. Fix issues while code is still in the editor.
Scattered enforcement
Different tools, spreadsheets, and tribal knowledge. RegEngine brings rules and fixes into one place.
Inconsistent fixes
One-click remediation that follows certified patterns—audit trail, auth, integrity—so fixes are consistent and defensible.
Analyze. Fix. Enforce.
Integrate with your IDE or use the live demo. RegEngine evaluates code against FDA Part 11 (and more), surfaces violations, and applies compliant patterns with a single click.
Real-time analysis
As you type, RegEngine checks for audit trails, user attribution, timestamps, and data integrity. No “Analyze” button required.
One-click fixes
Each violation gets a suggested fix. Apply per-rule or fix all. Code is updated with certified compliance patterns.
Enforcement modes
Advisory (warn), Enforced (must fix), or Blocking (no ship). Match mode to environment—dev, staging, or production.
Built for regulated workflows
Rules engine, versioned rule packs, and remediation tuned for healthcare and life sciences.
FDA Part 11 rules
11.10(c) access control, 11.10(e) audit trail, 11.10(a) integrity—checked and fixed inline.
Compliance patterns
Append-only audit log, electronic signature, validated data update—reusable, versioned, certifiable.
API + Cursor plugin
Call /v1/analyze and /v1/fix-violation from any client, or use the RegEngine Code Assist extension in Cursor.
See it in action
Run the demo with sample healthcare code. Change enforcement mode, fix violations one by one, and watch compliant code apply.
Open the demo