Integrations

Every batch,
fully evidenced.

BatchCortex pulls LIMS results, material genealogy, and NIR PAT predictions into one immutable record per batch — so every batch is inspection-ready, not just monitored.

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A dashboard shows you a number. BatchCortex captures the evidence behind it.

Most monitoring tools stop at a trend line. Our differentiator is depth: the QC result, the material lot, the spectral prediction — each one captured, hashed, and tied to the batch an inspector will eventually ask about.

LIMS at-line QC

Analyze & Guard

Pull quality-control test results — assay, dissolution, content uniformity — straight into the batch record and the annual Product Quality Review.

Evidence it produces

  • Process capability (Cpk) per test method
  • OOS / OOT incidents flagged against spec bands
  • Per-result provenance: analyst, instrument, sampled & tested timestamps

How you connect

Connect today via CSV import. LabWare, STARLIMS, and Sample Manager adapters come online during onboarding.

Material genealogy & recall trace

Analyze & Guard

Link every API, excipient, and packaging lot to the batches that consumed it — so a recall is a query, not a week of spreadsheets.

Evidence it produces

  • Forward & backward lot-to-batch trace in constant time
  • Supplier CoA hashes captured per lot
  • Dispense events with quantity, scale serial, and operator attribution

How you connect

Connect today via CSV import. SAP, PAS-X, and Oracle MES/ERP adapters land post-pilot.

NIR PAT & Annex 22 drift

Guard

Ingest near-infrared blend-uniformity predictions and monitor input-data drift against the model's validated baseline — the heart of EU GMP Annex 22 readiness.

Evidence it produces

  • Per-prediction potency, moisture, and uniformity with confidence
  • Input-drift (PSI) scored against the frozen training baseline
  • Frozen model lineage: model hash, version, validated range

How you connect

Streams from your line via read-only OPC-UA edge push — the agent never writes to your equipment.

Every ingestion is an audited event

Every import runs as a tracked adapter run with replay detection, an integrity hash, and the reason & ticket reference 21 CFR Part 11 §11.10(e) requires. Connections are read-only — BatchCortex never writes to your production systems — and all data stays in the EU.

Verify a packSee the compliance map

What unlocks at each tier

StreamMonitorAnalyzeGuard
LIMS at-line QC
Material genealogy & recall trace
NIR PAT & Annex 22 drift

Full tier breakdown on the pricing page.

Turn every batch into evidence.

Pilot BatchCortex on one line and see the depth for yourself — at half price, for 90 days.

Apply for Pilot