AI-Driven GxP Compliance Assistant for Biotech Teams

Generate audit-ready SOPs, deviation reports, and validation logs in minutes — not hours

See how GxP Genie fits your QA workflows in just 15 minutes.

Free early access for biotech QA teams — no setup required.

Proactive Audit Assistant

Empower your QA team with an AI-powered assistant that continuously monitors compliance, instantly answers audit-related questions, and keeps you prepared for any inspection. It automatically:

  • Answers regulatory and compliance queries with instant accuracy.

  • Checks documents and processes against compliance standards in real time.

  • Identifies potential audit risks early, helping prevent compliance gaps.

  • Flags missing or incorrect documentation, simplifying audit prep.

  • It all begins with an idea. Maybe you want to launch a business. Maybe you want to turn a hobby into something more.

  • It all begins with an idea. Maybe you want to launch a business. Maybe you want to turn a hobby into something more.

Smart Deviation Logging & Report Automation

Seamlessly enter basic deviation details—our AI-powered bot shapes complete, compliant deviation reports for you. It automatically:

  • Formats reports and aligns them to the relevant SOP clauses

  • Suggests corrective/preventive actions

  • Pre-fills fields for quicker approval and sign-off

Instant SOP Creation & Audit‑Ready Drafts

Accelerate your SOP creation with an AI-driven assistant that quickly transforms your notes and templates into fully compliant, audit-ready SOP drafts. It automatically:

  • Analyzes existing templates and protocol notes instantly.

  • Generates complete, structured SOP documents within minutes.

  • Ensures compliance by including all required regulatory sections.

  • Minimizes manual edits, speeding up review and approval.

  • It all begins with an idea. Maybe you want to launch a business. Maybe you want to turn a hobby into something more.

  • It all begins with an idea. Maybe you want to launch a business. Maybe you want to turn a hobby into something more.

  • It all begins with an idea. Maybe you want to launch a business. Maybe you want to turn a hobby into something more.

  • It all begins with an idea. Maybe you want to launch a business. Maybe you want to turn a hobby into something more.