FDA 21 CFR Part 11 ISO 13485 cGMP

AI-Powered Compliance,
Delivered in Minutes

Production-grade AI compliance engines — same deliverables a $300/hr consultant produces, delivered in minutes for dollars.

Pharmaceuticals
Medical Devices
Dietary Supplements
Cosmetics
Food Manufacturing

How It Works

Three steps to production-grade compliance deliverables.

Step 1

Upload Your Document

Upload an SOP, label, deviation report, or any quality document. Supports PDF, DOCX, and plain text.

Step 2

AI Analyzes Against Standards

Our engines cross-reference your document against FDA regulations, ISO standards, and cGMP requirements.

Step 3

Get Structured Report

Receive a consultant-grade report with findings, severity scores, regulation citations, and recommended corrections.

AI Compliance Engines

Each engine is a production-grade tool that delivers structured compliance deliverables. Pay per run or subscribe.

$8/run

SOP Gap Analysis

Identifies gaps in your SOPs against ISO 9001, ISO 13485, and 21 CFR Part 211.

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$5/run

Label Review

FDA compliance review for OTC drugs, dietary supplements, medical devices, and cosmetics.

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$15/run

CAPA Draft

AI-drafted Corrective & Preventive Action plans with root cause analysis and effectiveness criteria.

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$12/run

Audit Readiness

Pre-audit assessment with readiness score, gap inventory, and prioritized preparation actions.

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$3/run

Deviation Triage

Fast classification of deviations by severity with risk evaluation and response pathway.

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$5/run

Change Control Impact

Evaluates impact of changes across quality, regulatory, validation, and supply chain systems.

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$10/run

Supplier Qualification

Risk-based assessment of supplier QMS maturity, compliance history, and technical capability.

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+ More engines coming
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Coming Soon

The Nova QMS Platform

A complete AI-driven, paperless Quality Management System built for FDA-regulated industries.

Voice-First Interface

Talk to your QMS. NOVA understands context and populates records hands-free.

Dual AI Roles

NOVA helps you work. Verifier audits for compliance. Two AI roles, zero blind spots.

E-Signatures & Audit Trail

FDA 21 CFR Part 11 compliant electronic signatures with immutable audit trails.

Cross-Reference Intelligence

Automatic traceability between deviations, CAPAs, batches, and quality records.

The Math is Simple

Same quality deliverables. Fraction of the cost and time.

Traditional Consultant
$300/hr
  • 2–4 hours per deliverable
  • $600–$1,200 per assessment
  • Scheduling delays and limited availability
  • Inconsistent between reviewers
95% SAVINGS
Nova QMS
$3–15/run
  • Minutes, not hours
  • Available 24/7, no scheduling
  • Consistent, deterministic quality
  • Full regulatory citations included

10 SOP gap analyses: Consultant = $6,000–$12,000. Nova = $80.

Simple, Transparent Pricing

Pay per run or subscribe for volume discounts. Every plan includes 3 free runs per engine per month.

Starter

For small quality teams

$29/mo

25 runs/month included

  • All engines included
  • $3/overage run
  • Email support
Get Started
MOST POPULAR

Professional

For growing organizations

$99/mo

100 runs/month included

  • All engines included
  • $2/overage run
  • Priority support + API access
Get Started

Enterprise

For regulated enterprises

$299/mo

500 runs/month included

  • All engines included
  • $1/overage run
  • Dedicated support + custom integrations
Contact Sales

Or pay per run, starting at $3. View full pricing →

Ready to Transform Your
Compliance Workflow?

Start with 3 free runs per engine. No credit card required.