Your batches fail at 5–7%. We make that number zero.
AI-powered quality copilot that detects deviations before they become failures — and writes the investigation report for you.
🔒 EU-sovereign · GMP Annex 11 compliant · Data stays in Europe
Average cost per deviation investigation
Industry average (ISPE baseline)
Global pharma batch failure rate
BioPlan Associates, 434 facilities
Tablets produced between manual checks
Standard 30-min sampling at 100K tablets/hr
Watch BatchCortex work in real time.
No login required.
Live Sensors — Tablet Press Line 3
Station Compression Forces (45 stations)
Batch BC-2041 | Paracetamol 500mg
ML Ensemble Status
Press "Simulate Deviation" to see the 11-layer ensemble detect a punch wear failure in real time.
“This is exactly what your QA team would see. Except it would be your batch, your equipment, your data.”
Calculate Your Savings
Adjust the sliders to see how BatchCortex impacts your bottom line.
Estimated Gross Savings
€825K
Based on 30% reduction in batch failures through 15–30 minute early drift detection. Actual results vary by process type and facility.
The Hidden Tax on Every Batch
Quality failures are not rare events. They are a systemic cost baked into every production run.
1,000 deviations/year
Your QA team spends 6,000+ hours investigating. Most are documentation errors.
€50K–€5M per failed batch
Raw materials lost. Production time gone. Release delayed weeks.
4–8 hours per batch record review
Manual review is the bottleneck between production and release.
250,000 tablets between checks
Your operators sample 20 tablets every 30 minutes. That’s a 0.02% sampling rate. The other 99.98% are unchecked.
Current batch failure flow
How BatchCortex Works
Four steps. From deviation detection to signed documentation.
STEP 01
DETECT
11-layer ML ensemble monitors every station, every tablet, every second. CUSUM catches 1σ shifts in 10 readings — while your Shewhart chart needs 44. That’s 18 minutes of early warning your team doesn’t have today.
STEP 02
ANALYZE
Contribution plots show exactly which features drove the alarm. Station 23 punch wear vs feeder blockage — diagnosed in milliseconds, not hours. Every alert is inspector-ready with full traceability.
STEP 03
DOCUMENT
Auto-generates ALCOA+ compliant deviation reports, batch record annotations, and CAPA drafts. Ready for QP signature.
STEP 04
Zero-Latency Escalation
The moment an anomaly is detected, BatchCortex doesn't wait for someone to check the dashboard. It fires an SMS and email to your QA Manager instantly. No response in 3 minutes? Your QA Director gets the same alert. Still nothing? An automated phone call reads the full batch status report aloud. Your team has the information to save the batch before most systems have even logged the event.
Live Dashboard Preview
Batch #PH-2024-1847 — Tablet Compression Line 3
Station Heatmap (45 stations)
Hotelling's T² / SPE Control Chart
Ensemble Anomaly Score
Root Cause — Feature Contributions
AI RECOMMENDATION
Station 23: Main compression force trending +0.8σ/hour. Cross-station correlation: 0.71 (normal: >0.90). Pattern matches punch wear (confidence: 94%). Estimated time to spec breach: 18 minutes. Recommended action: Inspect punch tooling, Station 23.
Equipment Integration
Connects to your existing systems. No modifications required.
BatchCortex connects to your existing manufacturing systems via industry-standard protocols. Your equipment does not need to be modified. We read data from your control systems in read-only mode — we cannot write to your production equipment.
OPC-UA
Industry standard. Covers 60–70% of pharma DCS/SCADA systems (Siemens, Rockwell, ABB, Emerson DeltaV). Auto-reconnects with exponential backoff if the connection drops.
MQTT
IIoT setups, Siemens MindSphere, and modern sensor networks. Full anomaly detection pipeline — same AI as OPC-UA mode.
Your batch data stays in Europe.
While most AI platforms route your sensitive manufacturing data through US servers, BatchCortex runs on Swedish infrastructure. Your process data, your IP, your patients — all protected under EU jurisdiction.
Hosted in Sweden
Production AI runs on Berget AI's Swedish servers. EU data residency guaranteed. GDPR compliant by architecture, not by policy.
Sovereign from day one
BatchCortex was designed for the EU AI Act before most vendors knew it existed. Annex 22 compliant. No US data transfers for production workloads.
No vendor lock-in
Built on open-weight European AI models. Mistral Large via Swedish data centers from 2027. Your compliance doesn't depend on a San Francisco boardroom.
Developed in Sweden · The Silicon Valhalla · EU AI Act compliant · batchcortex.com
Built for GMP from Line One
Regulatory-ready. Not an afterthought.
Every feature is designed with pharmaceutical compliance requirements at its core.
EU GMP Annex 11
Compliant
EU GMP Annex 22 (AI)
Ready
21 CFR Part 11
Designed for
GAMP 5 Category 5
Validation package in development
ALCOA+ Data Integrity
Compliant
EU AI Act
Limited risk — classified
Sartorius SIMCA-equivalent
PCA/T²/SPE monitoring
Human-on-the-loop architecture. Every AI recommendation requires operator approval. Full audit trail. No black boxes.
Same math. Deeper intelligence.
We use the same PCA/T²/SPE monitoring that SIMCA pioneered — plus five additional detection layers that catch what multivariate statistics alone cannot.
Traditional MVDA (SIMCA, etc.)
BatchCortex
PCA on batch-level averages
11-layer ensemble on per-station, per-second data
Tells you a batch went wrong
Tells you WHICH station, WHICH failure mode, and HOW LONG until spec breach
∼€50K license + training
Pay-per-batch, no license
General-purpose toolkit
Purpose-built for tablet compression
Manual model building
Auto-calibrating ensemble
No temporal awareness
TCN + LSTM autoencoders detect drift patterns
SIMCA is the gold standard for multivariate batch analysis. BatchCortex builds on that foundation with purpose-built layers for tablet compression — same statistical rigor, deeper real-time intelligence.
Pay Per Batch. Not Per Promise.
Transparent pricing tied to your production volume. No surprises.
Monitor
+ €3,500 one-time setup
Real-time visibility into your batch process.
- OPC-UA & MQTT connectivity
- Real-time parameter monitoring
- Hard limit & drift detection
- Automated SMS/email escalation
- Immutable audit trail
- Annex 11 compliant dashboard
Analyze
+ €6,000 one-time setup
AI-generated GMP deviation reports and electronic sign-off.
- Everything in Monitor
- AI deviation report generation (<60s)
- Electronic sign-off (21 CFR Part 11)
- QA feedback loop & model improvement
- IQ/OQ validation document support
- EU-sovereign AI inference (Berget AI)
Guard
+ €8,500 one-time setup
Full GMP compliance stack with dedicated onboarding.
- Everything in Analyze
- Custom OPC-UA/MQTT integration support
- Dedicated onboarding engineer on-site
- Custom alert thresholds & escalation rules
- Priority support (4-hour response)
- Multi-line monitoring (unlimited lines)
One-time setup fee per site. No multi-year lock-in. Cancel anytime.
Frequently Asked Questions
Common questions about BatchCortex, GMP compliance, and our pilot program.
First 3 pilot partners get 50% off setup — and a custom ML model trained on your press data
50% off the one-time setup fee in exchange for a brief written case study after 90 days. EU AI Act enforcement begins August 2026 — validate your AI pipeline now and gain a 12-month compliance head start. Secure your pilot spot before ISPE Copenhagen.
Vilmer Frost
Founder, BatchCortex — Stockholm, Sweden
Built by a developer who spent months studying EU GMP regulations before writing a single line of product code. BatchCortex exists because the compliance gap is real and the existing solutions are too slow, too expensive, and not built for EU data sovereignty.
Get in Touch
Have a question about BatchCortex, Annex 22 compliance, or pilot partnerships? We'd love to hear from you.