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The Nova QMS Platform

AI-driven, paperless quality management for FDA-regulated industries. Talk to your QMS. Let AI handle the rest.

Built Different

Nova QMS isn't another document management system. It's an AI-native platform that understands compliance.

Voice-First Interface

Talk to your QMS. NOVA understands context, extracts structured data from natural speech, and populates records — hands-free. Perfect for clean rooms and production floors.

Dual AI Roles

NOVA is your conversational helper — drafts records, answers questions, populates fields. Verifier audits everything for compliance. Two roles, zero blind spots.

Schema-Driven Records

15+ QMS record types with AI context hooks that tell the system how to behave per record. Extract-on-save pattern minimizes hallucinations. Structured data, not free text.

Built for FDA 21 CFR Part 11

Every feature is designed with regulatory compliance as the foundation — not bolted on as an afterthought.

  • Electronic Signatures with Meaning Codes

    Compliant e-signatures with author, reviewer, and approver roles — each with documented intent.

  • Immutable Audit Trails

    Every action, change, and AI interaction is logged with timestamp, user, and context. Nothing can be deleted.

  • Role-Based Access Control

    Granular permissions by role, department, and record type. Quality managers, operators, and auditors each see what they need.

  • Version-Controlled Records

    Full history for every record. Compare versions, see who changed what, and roll back when needed.

  • Cross-Reference Intelligence

    Automatic traceability links between deviations, CAPAs, batches, and quality records. See the full picture.

Enterprise-Grade Architecture

Modern tech stack built for regulated environments.

Next.js + React
Modern frontend
FastAPI + Python
High-performance backend
Supabase PostgreSQL
45+ tables, RLS, triggers
AI Orchestrator
GPT-4o + deterministic rules

Be Among the First to Use Nova QMS

Request early access to get hands-on with the platform before general availability.