Introduction

Clarix is a comprehensive digital platform designed for FDA-registered 503B outsourcing compounding facilities. It replaces paper-based batch records, manual quality tracking, and disconnected compliance workflows with a unified, auditable digital system.

What is Clarix?

Clarix provides end-to-end digital management for sterile compounding operations:

• Digital Batch Records — Step-by-step guided execution with e-signatures
• Inventory Management — Lot tracking, FIFO enforcement, expiry alerts
• Environmental Monitoring — Room monitoring, sample schedules, excursion tracking
• Quality Management — Deviations, CAPAs, document control
• Equipment & Calibration — Registry, calibration schedules, cleaning logs
• Training & Compliance — Personnel qualifications, 21 CFR Part 11 compliance

Architecture

Clarix is built as a monorepo with the following structure:

clarix/
├── apps/
│   ├── web          — Next.js dashboard (admin, management)
│   ├── mobile       — React Native / Expo (iPad + Android)
│   └── docs         — Documentation (you are here)
├── packages/
│   ├── auth         — Better Auth + RBAC
│   ├── db           — Drizzle ORM + PostgreSQL
│   ├── observability — Pino logging + OpenTelemetry
│   └── utils        — Shared utilities (BUD calculator, etc.)

Technology Stack

Regulatory Compliance

Clarix is designed to comply with:

• 21 CFR Part 11 — Electronic records and signatures
• USP <797> — Sterile compounding standards
• cGMP — Current good manufacturing practices
• FDA 503B — Outsourcing facility requirements