MRK III - QualForge — screenshot 1
MRK III - QualForge — screenshot 2
MRK III - QualForge — screenshot 3

MRK III - QualForge

From a brochure to a signed audit-ready validation binder in hours, not weeks

NextGen BioAgents Hackathon - NYTechWeek

Additional info

Project Slide Deck Link

docs.google.com/presentation/d/1u-3rQVXrRGcZwV7p7eW-4ztSWNVog4rC/edit?usp=sharing&ouid=108155978115745317399&rtpof=true&sd=true

Team

3 members
  • KE

    Kevin Ortiz

  • MA

    Manil Shah

  • RA

    Raj Bora

    Owner

Overview

QualForge is an agentic copilot that turns a piece of equipment's brochure into a complete, e-signable GMP qualification binder — URS → IQ → OQ → PQ → RTM → VSR — in an afternoon instead of a week. A multi-agent pipeline drafts every document in dependency order under a deterministic rulebook, so the AI never invents a regulatory requirement, and a human SME signs every page. Live and working mvp at markiii.vercel.app.