Built to solve a problem no one else is solving
No company on Earth currently offers a GxP-validated AI system for real-time pharmaceutical batch monitoring. BatchCortex is changing that.
€50K–€5M
Lost per failed batch
Annex 22
The regulation driving AI adoption
100% EU
Data residency, by architecture
21 CFR Part 11
Audit trails & e-signatures
Vilmer Frost
Founder & Developer
I'm a 17-year-old developer based in Stockholm, Sweden.
I built BatchCortex after identifying a genuine market gap: pharmaceutical manufacturers lose €50,000–€5,000,000 per failed batch, yet no validated AI system exists to monitor and flag deviations in real time.
EU GMP Annex 22 is creating a regulatory tailwind for AI adoption in pharmaceutical manufacturing. BatchCortex is purpose-built for that moment — combining real-time process monitoring, multivariate anomaly detection, and GMP-compliant audit trails in one platform.
We're starting in the Nordic market and expanding across Europe.
The Problem
Billions lost annually
Batch failures cost the pharmaceutical industry billions every year. A single failed batch can mean €50K–€5M in lost materials, investigation costs, and delayed releases.
The Opportunity
Annex 22 mandates AI readiness
The EU's upcoming Annex 22 guidance creates regulatory requirements — and incentives — for AI adoption in GMP manufacturing. Early movers gain a compliance advantage.
Our Approach
Human-on-the-loop AI
BatchCortex keeps humans in control. AI analyzes and recommends; qualified personnel approve. Full audit trails, electronic signatures, and ALCOA+ compliance built in from day one.
What we build on
Principles that don't bend
Pharma doesn't reward shortcuts. These are the constraints we designed the platform around — and we hold them even when it would be easier not to.
Regulation first
When a design tradeoff arises, the choice that satisfies GMP, Annex 11, and 21 CFR Part 11 inspectors wins — even at the cost of convenience.
Capture everything
More evidence per batch is a regulatory moat. We log OPC quality codes, source timestamps, and full provenance — not just sensor values.
Tamper-evident by design
The audit trail is append-only at the database level with chained SHA-256 signatures. Enforced by a Postgres trigger, not a policy.
Read-only on the floor
BatchCortex never writes to your production systems. Edge agents connect with read-only OPC-UA credentials. We observe; we never control.
Invite-only access
No self-signup. Your admin controls exactly who has access, with roles scoped to operator, QA, QP, and admin.
European, end to end
Mistral (France), Vercel Frankfurt, Twilio Dublin, Supabase EU. Your batch data is processed within EU infrastructure under EU law.
Want to see it on your line?
We run a 90-day pilot with a handful of EU manufacturers. On-site deployment, IQ/OQ walkthrough, and a real batch monitored end to end.
EU data residency · GMP-compliant audit trail · Invite-only onboarding