For more than 30 years, StatSoft has helped pharmaceutical companies turn complex Quality data into reliable action.
At CPHI Europe 2026, we show how proven analytics, pharmaceutical expertise, and AI protect batches, accelerate decisions, and make Quality a measurable business advantage.
Quality is our Discipline
StatSoft has worked at the intersection of pharmaceutical Quality, statistics, and manufacturing for more than three decades. This depth matters because Quality in Pharma cannot be reduced to software alone. It requires an exact understanding of processes, data, methods, regulatory expectations, and the operational reality behind every batch.
We live Quality in the way we design, implement, and support our solutions. Analytical rigor, transparency, traceability, and validation readiness are not added at the end. They are built into the work from the beginning. Pharmaceutical and statistical experts remain in control of methods, results, and decisions.
That combination is what makes StatSoft different. We bring together profound statistical expertise, hands on Pharma experience, proven implementation capability, and the ability to translate innovation into solutions that people can trust in regulated environments. We do not introduce AI as a black box. We apply it where it creates measurable value and where its output can remain understandable and governed.
Quality Solutions in Practice
At CPHI, StatSoft presents a connected portfolio for pharmaceutical Quality.
Stability-Analysis and Trending
Stability supports robust evaluation of product performance over time and enables reliable, regulatory ready decisions.
Robust stability evaluation and trending across all studies and sites.
- Regulatory-ready decisions
- Trend analysis & shelf-life optimization
- Full traceability & audit readiness
Automated Visual Inspection
Automated Visual Inspection turns inspection data into evidence, helping teams understand detection performance, investigate variability, and improve inspection processes.
Turn inspection data into evidence and continuous improvement.
- Understand performance
- Detect variability & root causes
- Improve processes & reduce risk
Further applications support process understanding, root cause analysis, OOS and OOT investigations, CPV, PQR, and reliable batch evaluation.
AI-Assisted Decisions
The next step in Quality is not replacing expertise. It is making that expertise available to far more people. StatSoft uses AI to create an intuitive natural language access layer for governed data, established methods, and controlled analytical workflows. Users can ask relevant questions in everyday language and receive analyses, visualizations, and evaluations without having to master complex analytical software.
Expert Quality for everyone – governed, transparent and in control.
- Ask in natural language
- Get governed analyses & insights
- Experts stay in control
This makes Stability results, inspection data, process information, and Quality evaluations accessible through natural language while the analytical logic remains controlled. The interface does not independently invent calculations or conclusions. It translates the user request into approved analytical processes based on governed data. The result is broader access without sacrificing transparency, traceability, or expert oversight.
AI – without the black box.
- GOVERNED & SECURE — Your data. Your rules. Your control.
- VALIDATED & TRANSPARENT — All methods, logic and results are traceable.
- EXPERT OVERSIGHT — AI supports. Experts decide.
- REGULATORY READY — Built for compliance from the ground up.
The C-Level Case
For executives, the value is direct. Earlier recognition of critical patterns and faster root cause analysis can reduce rejected batches, avoid write offs, and protect margin. More stable processes improve yield, asset utilization, and cost of goods. Faster, evidence based investigations support shorter release cycles and more reliable supply. Better use of existing data reduces manual Quality effort, focuses scarce expert capacity on the highest value questions, and strengthens inspection readiness.
The business outcome is stronger operational resilience: fewer surprises, faster decisions, greater confidence in every batch, and a Quality organization that actively supports growth, customer commitments, and competitive differentiation.
Real Impact
- Faster investigations — Shorter release cycles.
- More stable processes — Improve yield & asset utilization.
- Better use of data — Reduce manual Quality effort.
- Operational resilience — Stronger supply. Fewer surprises.
MEET STATSOFT IN MILAN 6 to 8 October 2026 | Prange Pharma booth 8F34
