Products · #16 · Operations & Forecasting

TIER B BLUEPRINT

Spectroscopic QC Pipeline

Turn NIR / Raman / FTIR spectra into validated release decisions - chemometrics + ML with a GxP-grade audit trail.

from €4,990

BATCH B-2026/1147 · NIR SCAN - CONTENT UNIFORMITY

absorbance spectrum regions driving the call

Prediction - API content · model: PLS v7 (validated)

99.2%interval 98.7 - 99.7 · spec: 95.0 - 105.0 · WITHIN VALIDATED RANGE

R² 0.994 ✓ RMSEP 0.31 ✓ control sample ✓ instrument drift ✓

→ QP RELEASE QUEUE · full evidence attached
🔴 the Qualified Person signs the release - always. The pipeline provides evidence, never the decision.

B-2026/1148 ▸ spectrum outside validated range → ABSTAIN → routed to manual lab assay · logged ⛓

How it works

⚠ Validation plan before any model

Written per ICH Q2(R1) / Q14 with your QA: acceptance criteria, intervals of validity, revalidation triggers. Your QP signs the plan - building first and validating after is how vendors fail inspections.

Locked preprocessing, PLS first

SNV, Savitzky-Golay, derivatives - versioned and locked per the plan. PLS baseline (inspectors know PLS); deep models only if they demonstrably beat it.

Every call is attributed

The spectral regions driving each prediction are shown - chemistry your QC team can sanity-check, not a black box over wavelengths.

Outside validity = abstain

Predictions carry intervals; anything beyond the validated range refuses to answer and routes to manual assay. Instrument + batch drift trigger recalibration, control samples tracked.

The Four Guarantees™ - this build

Measured value

~75% of release-test labour cut at reference volume. GxP validation gate: R²/RMSEP, accuracy, precision, robustness - per the signed plan.

Defensible

Spectral-region attribution per call; 21 CFR Part 11 / EU Annex 11 audit trail; validation dossier auto-generated from each run.

Self-correcting

Predictions with uncertainty; instrument & batch drift with automatic recalibration triggers; control-sample tracking; abstention outside validity.

Yours & everywhere

On-prem where GxP requires it; LIMS integration; full source. MCP tools for QC agents (🔴 no release-decision tool exposed).

The number, sized honestly

Reference buyer: EU pharma or specialty-food QC lab, ~5,000 batches/yr, release-test cycle ~4 hours/batch, manual model rebuilds on every product change.

4h → 1h release-test cycle per batch - the agreed number (conservative)

€350-500k per year in release-test labour ≈ 7 FTE-equivalents at this volume

~3 mo payback at the PoC tier, on labour alone

€500k+ typical cost to remediate one GMP citation for inadequate model validation - context, not a promise

Three ways to own it

Tier	What you get	Price
Scaffolding ★	The full repo - preprocessing + PLS/CNN harness, GxP-grade R²/RMSEP validation gates, drift + control-sample tracking, audit log, MCP server.	€4,990
PoC ★★RECOMMENDED	Chemometric models trained on your spectra - prediction quality measured against your reference-lab results, GxP evidence trail included. Code + quality report yours. No guarantee at PoC.	from €15,000
Implementation ★★★	Production: validated pipeline in your QC flow, instrument-drift monitoring, model lifecycle under change control, audit-ready documentation maintained - the agreed number (conservative) attaches here.	from €45,000

★ = engagement depth. PoC is the recommended path: quality proven on your data before production money. The PoC carries no performance guarantee by design; the agreed number (conservative) attaches at Implementation, informed by the PoC report.

What we don't promise

The regulatory bar here is the highest in our catalog - and the decision is never ours. Your Qualified Person signs the validation and every release; we provide the tool and the evidence package, not the regulatory judgment. No model gets built before the validation plan is signed, and predictions outside the validated range abstain rather than guess - a system that knows its own limits is the only kind an inspector should ever see.

Ready to see your own number?

Request the build: within 48h you get a personal reply with the value sized to your volume.

No commitment · reply within 48h · your data stays in the EU