NAVIGATION 13.5 kn HDG 250° · SOG nominal ↑ ETA Hamburg +7 min CARGO STATUS 5 bays · 849 TEU Integrity: 98.7% 1 FLAG ENGINE ANALYTICS RPM 78 · Temp 352°C Fuel eff. +4.7% vs baseline BRIDGE SYSTEMS All nominal 6 / 7 sys
StatSoft — Hamburg, Krakau, Kopenhagen

From Hidden

Analytics
to

Predictive

Intelligence.

Seit Jahrzehnten arbeitet StatSoft dort, wo Qualität nicht sichtbar ist — aber absolut entscheidend. Pharmazeutische Fertigung, Hightech-Produktion, Energieinfrastruktur.

Unser Fundament

Gebaut um Qualität —
nicht um Dashboards.

StatSoft wurde nicht um Dashboards oder abstrakte Modelle herum gebaut. Es wurde in Umgebungen gebaut, wo ein einziges verpasstes Signal eine zurückgerufene Charge, ein fehlgeschlagenes Audit oder einen Produktionsstopp bedeuten kann.

Wir behandeln Qualität nicht als Ergebnis. Wir planen von Anfang an dafür.

Ensuring data integrity and traceability across complex systems
Detecting deviations that impact process quality
Stabilizing operations where quality cannot fail
Turning raw data into reliable, quality-assured insights
30+ Jahre Erfahrung

Analysen in hochregulierten, komplexen Industrieumgebungen bereitgestellt.

40+ Bewährte Lösungen

Über 8 Module — von SPC und FDC bis zu KI-Ertragsprognose und digitalen Zwillingen.

3 Kernbranchen

Pharma, Hightech-Fertigung & Halbleiter, Energie & Infrastruktur.

1 Intelligence Fabric

Eine einheitliche Datenbasis über alle Module und Produktionssysteme hinweg.

Die Reise

Vom Maschinenraum
auf die Brücke.

StatSofts analytische Präzision war immer die verborgene Kraft, die die Produktion am Laufen hielt. Jetzt bewegt sich diese Intelligenz von der unsichtbaren Infrastruktur hin zur strategischen Führung.

Bis jetzt

Der Maschinenraum.

StatSoft-Expertise lebte tief in der Infrastruktur — in Prozesshistorikern, LIMS-Systemen, SPC-Modulen. Unverzichtbar, aber unsichtbar. Qualität lief. Niemand fragte warum.

Analytics as IT infrastructure
Insights for specialists only
Reactive — after the event
Data as operational burden
ENGINE ROOM BELOW WATERLINE

Aufwärts

WATERLINE ENGINE ROOM Intelligence rising
Die Wende

Daten durchbrechen die Oberfläche.

Die Intelligenz, die die Produktion am Laufen hielt, beginnt ihren Aufstieg. Prozessdaten, Qualitätssignale und KI-Erkenntnisse steigen aus der Tiefe auf — zur Entscheidungsebene.

Data unified across silos
Signals becoming insights
AI pattern recognition active
Command comes into view

Auf der Brücke

Mit QuAI

Auf der Brücke.

Lernen Sie QuAI kennen. StatSofts analytische Tiefe — jetzt auf strategischer Ebene. Produktionsdaten, Qualitätsintelligenz und KI-gesteuerte Entscheidungen, vereint auf der Brücke. Hier wird 30 Jahre Maschinenraum-Expertise endlich sichtbar.

Analytics as strategic leadership
Insights across all functions
Predictive — before the event
Data as competitive advantage
PROCESS INTELLIGENCE — LIVE YIELD 98.4% ↑ 2.1% vs last lot EQUIPMENT HEALTH 94% All tools nominal RELEASE MONITOR PREDICT REPORT QuAI BRIDGE — COMMAND & CONTROL

Der Paradigmenwechsel

Von reaktiver Kontrolle
zu prädiktiver Qualität.

Früher — Reaktiv
  • Detecting deviations after the fact
  • Investigating root causes manually
  • Documenting what has already happened
  • Reacting to problems
  • Quality control after production
Mit StatSoft — Prädiktiv
  • Forward-looking quality assurance
  • AI-driven root cause identification
  • Continuous, real-time process monitoring
  • Preventing problems before they occur
  • Quality embedded in every decision
Abweichungen vorwegnehmen
Identify quality issues before they occur — not after specification failures.
Kontinuierliche Überwachung
Monitor and improve process stability and yield in real time, across all systems.
Erklärbare KI
Apply AI without compromising quality standards — auditability by design.
Operative Intelligenz
Embed quality directly into every operational and management decision.

Why StatSoft

Weil wir Qualität dort verstehen, wo sie entsteht — nicht wo sie berichtet wird.

In komplexen Industrien ist Qualität kein Merkmal. Sie ist das Fundament. Wir bauen Systeme, die Qualitätsintelligenz am Produktionsort einbetten — nicht im Nachhinein.

  • 01.Data Quality
  • 02.Process Quality
  • 03.Decision Quality

Von Daten zur prädiktiven Aktion

RAW DATA Sensors · MES · LIMS THE PLATFORM AI · SPC · FDC · Vision PREDICTIVE Quality · Maintenance · Yield ACTION Decisions · Release · Control VALUE ROI · Quality INPUT ENGINE INTELLIGENCE OUTCOME IMPACT

Quality as a Strategic Lever

The Cost of Non-Quality is High. We fix that.

Every batch recall, failed audit, OOS event and production stop is not just a quality failure — it is a strategic and financial failure. StatSoft QuAI turns quality from a cost centre into a competitive advantage.

Batch Recalls & OOS EventsAverage cost per recall: €5–15M. Every OOS event triggers CAPAs, investigations and regulatory scrutiny that consume weeks of quality team capacity.
Failed Audits & Inspection UnreadinessManual, reactive preparation. Warning letters, import bans and remediation programmes cost orders of magnitude more than prevention.
Slow Time-to-MarketEvery unnecessary lab cycle is time competitors use. RTRT and AI-driven risk scoring cut release time by up to 40%.
Yield Loss & Material Write-offsUndetected process drift leads to batch failures that compound year on year into significant losses.

The Business Case for Quality Intelligence

40%
Faster Release
Reduce batch release cycles with RTRT & AI risk scoring
98%+
Inspection Readiness
Continuous ALCOA+ — always audit-ready
2.1×
Yield Improvement
Early drift detection prevents batch failures
−60%
CAPA Burden
Proactive SPC cuts corrective actions significantly
Before StatSoftWith QuAI
Quality after production
Embedded in every decision
Manual root cause investigation
AI-driven identification
Slow lab & release cycles
Faster release & readiness
Reactive troubleshooting
Proactive yield protection
Documenting what happened
Continuous real-time monitoring
Hamburg Alster
European by Origin
Hamburg · Copenhagen · Krakow

Qualität zuerst. By Design.

30 Jahre Erfahrung.

Seit mehr als 30 Jahren liefert StatSoft Analyse- und Entscheidungsunterstützungslösungen in den am stärksten regulierten Branchen der Welt.

StatSoft steht für

🎯
Consulting & Project Delivery

From requirements to go-live — StatSoft consultants work hands-on in your environment. We implement, configure, and validate QuAI within your existing infrastructure.

🎓
Training & Academy

Onsite and remote training for engineers, quality leads, and data teams. Covering statistical methods, AI workflows, and QuAI platform operation — tailored to your industry.

⚙️
Project Capability

Structured project management with GMP documentation, validation support, and regulatory readiness — from concept to qualification report.

Hamburg Elbphilharmonie
Hamburg · Deutschland
Krakow
Krakau · Polen
Copenhagen Nyhavn
Kopenhagen · Dänemark
🇪🇺 Europäisch von Ursprung
Kernteams und Betrieb in Deutschland, Polen und Dänemark. Tiefes Verständnis der GMP-Erwartungen, regulatorischen Rahmenbedingungen und Qualitätskultur in Europa und weltweit.
🌐 Global durch Relevanz
Für globale Skalierung gebaut — internationale Fertigungsorganisationen unterstützen, ohne lokale regulatorische Anforderungen zu kompromittieren.
🏢 Gestützt durch Größe
Teil einer großen, etablierten Unternehmensgruppe — Unternehmensstabilität mit der Agilität eines Spezialanbieters verbinden.
✓ Jenseits der Compliance
Datenintegrität und Rückverfolgbarkeit von Tag eins. Prüfbarkeit, Erklärbarkeit und Reproduzierbarkeit — eingebaut, nicht nachträglich hinzugefügt.

Open Architecture

No Vendor Lock-In.
Your data. Your systems. Your rules.

StatSoft QuAI connects to your existing MES, LIMS, ERP and historian systems — it does not replace them. You retain full data ownership and full control over your technology stack. Start small, scale as you grow.

Connects to Any Data SourceNative connectors for PI, OSIsoft, SAP, Siemens, Rockwell, Emerson and custom REST APIs.
Your Infrastructure, Your CloudOn-premise, private cloud or hybrid. No mandatory SaaS migration. GDPR-compliant EU data residency.
No Data HostageAll data remains in your systems. Export in standard formats at any time. Full audit trail ownership — always.
Modular — Use What You NeedStart with SPC. Add FDC, RTRT or Autonomous Visual Intelligence (AVI) as you grow. No forced bundling, no shelfware.
Typical ROI Timeline
Month 1–2
Connect & Configure
Month 3–4
First Insights
TARGET
Month 6
Full ROI
Open Intelligence Architecture
Your Systems & TeamsMES · LIMS · ERP · Historian · Custom APIs
QuAI Intelligence LayerSPC · FDC · AI · Autonomous Visual Intelligence (AVI) · RTRT
Your Data — Always YoursOn-prem · Private Cloud · EU Data Residency
"StatSoft does not lock you in — it opens up. Our clients typically see ROI within 6 months, with zero infrastructure hostage risk."
Die Plattform

Wir stellen vor: QuAI[kweɪ]

Eine einheitliche, modulare Analyseplattform — entwickelt für die komplexesten Produktionsumgebungen der Welt. QuAI verbindet Prozesskontrolle, KI, Autonomous Visual Intelligence (AVI) und Datenintelligenz in einem einzigen, skalierbaren Gefüge.

QuAI für Pharma QuAI für Hightech-Fertigung

QuAI for Pharma

Die einheitliche Plattform für pharmazeutische Fertigungsexzellenz.

QuAI für Pharma verbindet Prozessdaten, Qualitätsintelligenz, KI und Autonomous Visual Intelligence (AVI) in einer einzigen Plattform — für GMP-Umgebungen konzipiert, für Echtzeit-Entscheidungen gebaut.

"From reactive quality control to predictive pharmaceutical manufacturing — powered by data, AI, and vision."

Wichtigste Anwendungsfälle

Prädiktive Qualität
OOS/OOT Detection & Prediction AI-Assisted Quality Prediction Real-Time Release Testing Batch Release Risk Scoring
Prozessüberwachung
Statistical Process Control Multivariate Monitoring Continued Process Verification
Intelligente Fertigung
Predictive Maintenance Yield Optimization Digital Twin of Production
Intelligente Inspektion
Autonomous Visual Intelligence (AVI) for Production Lines Vision-based Anomaly Detection
01
Process Control
SPC · CPV · PPQ · MVDA · Golden Batch Modelling · Root Cause Analysis · DoE
CPV - Continued Process Verification
PPQ - Process Performance Qualification Report
SPC - Statistical Process Control
Process Capability & Variation Analysis
RCA - Root Cause Analysis
Process Deviation Analysis
DoE - Design of Experiments
Sampling Strategy Optimization
Multivariate Process Monitoring (MVP / MVDA)
Batch Reconstruction & Golden Batch Modeling
Design Space Monitoring
CPP–CQA Relationship Modeling
Process Knowledge Repository
02
AI-Assisted Quality
OOS/OOT Prediction · Batch Release Risk · RTRT · AI-Driven Release-by-Exception · ALCOA+
Stability & Shelf Life Modeling
OOS / OOT Detection & Prediction
Method Performance Monitoring
AI-Assisted Quality Prediction
AI-Driven Release-by-Exception
Real-Time Release Testing (RTRT) Support
Parametric Release Analytics
Batch Release Risk Scoring
Data Integrity Monitoring (ALCOA+)
GxP-compliant Process Documentation
Bioequivalence & Biowaiver Analytics
Regulatory-ready Analytics Reporting
03
Manufacturing Intelligence
Predictive Maintenance · Yield Optimization · Digital Twin · Material Flow · Supplier Quality
Predictive Maintenance (AI-based)
Downtime Analysis
Material Flow Optimization
Yield Optimization
Digital Twin of Production
Raw Material Variability Analysis
Supplier Quality Monitoring
Incoming Material Risk Scoring
Raw Material Impact on Process Performance
04
Autonomous Visual Intelligence (AVI)
AI Visual Inspection · Anomaly Detection · Defect Pattern Recognition · GMP Document Recognition
Autonomous Visual Intelligence for Production Lines
Vision-based Anomaly Detection
Automated GMP Document Recognition
05
Talk to Your Data
Natural Language Analytics · Self-Service BI · Regulatory-Ready Reporting
Analytics as Self Service
Natural Language Data Exploration

Business Impact

Schnellere Freigabe
RTRT and AI-driven batch risk scoring cut time-to-market by eliminating unnecessary lab cycles.
Weniger Abweichungen
Proactive SPC and AI anomaly detection prevent OOS events before they occur — reducing CAPA burden.
Inspektionsbereit
Continuous ALCOA+ compliance, automated audit trails and GxP documentation — permanent readiness, not event-driven.
Niedrigere Betriebskosten
Automated CPV, batch record analysis and regulatory reporting free quality teams for higher-value work.
Higher Yield & Faster Ramp-Up
Early drift detection and design space monitoring reduce batch failures, material write-offs and new product introduction timelines.

QuAI for Hightech Manufacturing

Gebaut für die anspruchsvollsten Fabs der Welt.

QuAI für Hightech-Fertigung ist eine integrierte Intelligenzplattform für Halbleiter- und Advanced-Fertigung — verbindet Prozesskontrolle, Anlagenanalytik, Fehlerintelligenz und KI in einem einzigen operativen Gefüge.

"QuAI for Hightech Manufacturing turns fragmented fab data into unified manufacturing intelligence — accelerating yield, stabilizing operations, and moving high-tech manufacturers from reactive troubleshooting to predictive, autonomous process excellence."
01
Process Control & Monitoring
SPC · APC · FDC · Virtual Metrology · Alarm Management · Equipment Performance
Alarm Management & Rationalization
Sampling Optimization
Parametric Test Analytics
Equipment Performance Monitoring
VM - Virtual Metrology
FDC - Fault Detection & Classification
APC - Advanced Process Control
SPC - Statistical Process Control
02
Metrology & Measurement Intelligence
MSA/GRR · Measurement Uncertainty · Calibration & Tool Matching · Process Window Analysis
Process Window Analysis
Calibration & Tooling Matching
MU - Measurement Uncertainty
MSA - Measurement Systems Analysis & GRR
03
Inspection & Defect Intelligence
Wafer Map Analysis · Defect Pattern Recognition · AOI Analytics · Yield Impact Scoring
Yield Management & Correlation
Defect Pattern Recognition (CV - ML)
Wafer Map Analysis & Signature Detection
AOI - Automated Optical Inspection Analytics
04
AI-Driven Operations & Quality
Anomaly Detection · Predictive Maintenance · AI Yield Prediction · Digital Twin
Automated Reporting & Insights Generation
Digital Twin - Virtual Fab
Dispatching & Prioritization Models
Cycle Time Analysis & Forecasting
Anomaly Detection
Predictive Maintenance
Intelligent Release - Lot Disposition Automation
AI-Driven Yield Prediction
05
Process Development & Qualification
DoE · Response Surface Modeling · Baseline Characterization · Process Qualification
Process Qualification & Release
Baseline Characterization
Variability & Sensitivity Analysis
Material & Recipe Optimization
Response Surface Modeling
DoE - Design of Experiments
06
Quality Governance & Reliability
CAPA Workflow · Compliance & Audit Trail · Lot/Wafer Genealogy · Failure Mode Analysis
Compliance & Audit Trail
CAPA Workflow Management
Lot & Wafer Genealogy and Traceability
Reliability & Failure Mode Analysis
RCA - Root Cause Analysis
07
Facilities & Infrastructure Quality
UPW Analytics · Chemical & Gas Monitoring · Environment Monitoring (Cleanroom)
UPW - Ultrapure Water Analytics
Chemical & Gas Distribution Monitoring
EM - Environment Monitoring
08
Intelligence Fabric
Data Integration & Connectivity (SEMI/GEM) · Role-Based Dashboards · Self-Service Analytics
Data Integration & Connectivity
Role-Based Dashboards & KPI Management
Analytics as a Self Service

Business Impact

Höhere Ausbeute
Integrated defect, process and test analytics identify yield loss drivers systematically — enabling faster learning and proactive yield protection.
Weniger Ausfallzeit
AI-based predictive maintenance and FDC detect equipment degradation before failure — reducing unplanned stops and tool-related excursions.
Schnellerer Hochlauf
DoE, process window analytics and digital twin simulation shorten new technology stabilization — protecting market windows and first-to-volume.
Prozessstabilität
APC, SPC and virtual metrology maintain critical parameters in control — run-to-run, lot-to-lot, across tools and fabs, at full scale.
Lower Scrap & Technology Readiness
Earlier excursion detection and systematic root cause analysis reduce material losses and rework. A scalable data platform that grows with your technology portfolio — supporting next node development and multi-site operations.

The Result

Fortgeschrittene Analytik, KI und Autonomous Visual Intelligence (AVI) — Qualität von einer Kontrollfunktion zu einer strategischen Fähigkeit.

Von verborgenen Systemen zu einem sichtbaren Leistungstreiber. Qualität ist nicht mehr etwas, das man prüft — sie wird zu etwas, das man kontinuierlich sicherstellt.

Advanced Analytics Artificial Intelligence Autonomous Visual Intelligence (AVI) Pharmaceutical Manufacturing Semiconductor Production High-Tech Manufacturing Energy & Infrastructure Explainable AI Predictive Quality GMP Compliance ALCOA+ Data Integrity Quality by Design
Vertraut von führenden Organisationen weltweit
roche
merck
bi
thyssen
helmholtz
danfoss
diehl
rodenstock
roche
merck
bi
thyssen
helmholtz
danfoss
diehl
rodenstock

Sie wissen es nicht,
aber Sie kennen uns bereits.

Aber Sie vertrauen uns schon lange Ihre Qualität an.

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The Challenge

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Key Capabilities

    v0.3.2

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