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.
Average cost per deviation investigation
Global pharma batch failure rate
QA review time reduced with BatchGuard
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.
Current batch failure flow
How BatchGuard Works
Three steps. From deviation detection to signed documentation.
STEP 01
DETECT
Real-time ML monitors every sensor on your line. Catches drift 10–30 minutes before it crosses spec limits.
STEP 02
ANALYZE
AI root cause analysis in seconds. Correlates across batch records, sensor data, and your SOPs.
STEP 03
DOCUMENT
Auto-generates ALCOA+ compliant deviation reports, batch record annotations, and CAPA drafts. Ready for QP signature.
Live Dashboard Preview
Batch #PH-2024-1847 — Tablet Compression Line 3
Compression Force
8.2 kN
Turret RPM
42.5
Tablet Thickness
5.31 mm
▲ DRIFT DETECTED
Ejection Force
1.8 N
Hardness
98 N
Weight Variation
±1.2%
AI RECOMMENDATION
Tablet thickness trending toward upper spec limit (5.31mm vs 5.40mm USL). Compression force adjustment of -0.3 kN recommended. Similar pattern in Batch #PH-2024-1802 resolved with pre-compression force increase.
Calculate Your Savings
Adjust the sliders to see how BatchGuard impacts your bottom line.
Estimated Annual Savings
$28.8M
BatchGuard Annual Cost
$100K
Analyze tier @ €50/batch
ROI
288.0x
Payback: 0 months
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 included
ALCOA+ Data Integrity
Compliant
EU AI Act High-Risk
Compliance roadmap
Human-on-the-loop architecture. Every AI recommendation requires operator approval. Full audit trail. No black boxes.
Pay Per Batch. Not Per Promise.
Transparent pricing tied to your production volume. No surprises.
Monitor
Know before it breaks.
- Real-time anomaly detection
- Sensor drift alerts
- Dashboard access
- Basic reporting
Analyze
Investigate in minutes, not weeks.
- Everything in Monitor
- AI root cause analysis
- Deviation report drafts
- CAPA recommendations
- SOP correlation engine
Guard
Full batch lifecycle protection.
- Everything in Analyze
- Remediation recommendations
- Full batch record review
- Predictive quality scoring
- QP release acceleration
Pricing finalized during pilot. Join waitlist for early access rates.
No setup fees. No multi-year lock-in. Cancel anytime.
First 10 pilot partners get 50% off Year 1
Join the waitlist to secure your spot and early access pricing.