Skip to content
Trust Center

Architecture

How RegEngine is built

Service topology, data flow from ingest to export, tenant isolation model, and infrastructure posture. This page is written for IT reviewers and security teams evaluating RegEngine for procurement.

System flow at a glance

The core path keeps customer-owned source data, authenticated request context, PostgreSQL tenant controls, and export review boundaries visually separate. Optional processors sit outside the default core path unless they are enabled or configured for a workspace.

Source systems

ERP, WMS, and supplier data sent as CSV uploads or JSON events API calls

Customer-owned data quality

App and API edge

Next.js app, authenticated routes, and mediated API traffic

Session and request context

Ingestion service

FastAPI validation, mapping, coverage and completeness checking, and workflow orchestration

Server-side tenant context

Tenant database

PostgreSQL records, RLS policies, append-oriented evidence handling

Core data isolation layer

Evidence exports

FDA-oriented spreadsheets, EPCIS (Preview) and CSV packages, and manifests where configured

Customer review and archive

Conditional processors
AI extraction where enabledObject storage where configuredTransactional email where configuredAnalytics after consent or workspace enablement

Service topology

This page describes the current service topology and intended control boundaries. Exact infrastructure details can vary by deployment and environment.

Frontend
Next.js 16 on Vercel

Current deployment posture uses a server-rendered React app with edge caching and proxy-based API routing so browser traffic is mediated before it reaches backend services.

Backend
FastAPI monolith on Railway

Single consolidated Python service for CTE ingestion, JSON events API validation, CSV parsing, compliance coverage and completeness checking, exports, and alert generation. The services directories are code-organization boundaries, not separate default deploys.

Database
PostgreSQL on Railway

Current database posture uses PostgreSQL tenant-scoping controls, append-oriented audit protections, and managed connection pooling.

Infrastructure
US-configured core hosting

Default active application/database hosting is US-based where configured. CDN, edge, AI, and object-storage processing locations vary by provider and executed DPA.

Data flow: ingest to export

The current product posture aims for a consistent five-stage pipeline from ingest to export, with integrity controls applied after validation.

1
Ingest

CTE events arrive via CSV upload or the JSON events API. Both paths run validation synchronously and persist before coverage checks. EPCIS 2.0 is in Preview.

2
Normalize

Raw event data is mapped to FSMA CTE/KDE structures. Lot codes, GLNs, and facility identities may be standardized, with exceptions or missing KDEs surfaced for review.

3
Hash & Chain

Validated events are SHA-256 hashed and chain-linked at ingest, scoped per tenant. Commit means accepted records are appended after checks you configure; this is not a certification. Independent verification of exported bundles is offered at /verify. Default deployments use PostgreSQL-backed task processing rather than a managed message bus.

4
Coverage & Completeness Checklist

The compliance engine produces an advisory coverage and completeness checklist across six weighted dimensions: export-checklist completeness, KDE completeness, CTE coverage, chain integrity, obligation coverage, and FTL product-list overlap. This is not a readiness score, not a badge, not an FDA or buyer decision. FTL overlap is list-membership, not a covered-person determination. Per-dimension maturity varies; rule enforcement is opt-in per workflow and is advisory in production today.

5
Export

Compliance records may be exported in one or more supported formats such as EPCIS 2.0 (Preview), FDA-oriented spreadsheets, or CSV, depending on the enabled workflow.

Tenant isolation model

Isolation is intended to be enforced as close to the data layer as possible rather than depending solely on application logic.

Row-Level Security

PostgreSQL row-level policies and authenticated tenant context are designed and tested to restrict reads on core PostgreSQL-backed paths. Identity-resolution and graph-layer hardening is in progress; details available under NDA.

Per-tenant hash chains

Integrity records are designed to remain tenant-scoped so one customer workspace does not depend on another customer's evidence chain.

API key scoping

API credentials and tenant context are intended to be scoped per customer workspace, with server-side mediation preferred over trusting raw client context.

Append-oriented audit handling

Compliance records are append-oriented after ingest; in-place mutation is not the supported path. Audit-chain coverage across review and admin surfaces is being expanded.

Infrastructure controls

Encryption at rest
Managed-cloud default
Encrypted storage is part of the current managed infrastructure posture
Encryption in transit
Encrypted transport
Client and service connections are intended to use encrypted transport
Data residency
US default
Current default posture for active deployments
Backup cadence
Platform managed
Backup and recovery posture depends on the active hosting configuration
CI/CD security
Current workflow controls
Secrets, SAST, and dependency gates run in CI; DAST, SBOM, and container scans run when configured or on scheduled/main-branch workflows
Branch protection
Repository controlled
Review and merge controls are managed at the repository level

Need more detail? The security page covers RLS testing, hash verification, and audit trail posture.

Verify supported evidence export bundles yourself: drop a supported bundle into /verify.