PTM Consulting acquired a consistent, recognized experience using and developing statistical tools, widely used within the Life Science field. Thanks to its statistic unit PTM can deliver both specific technical applications and activities related to Process Analytical Technology, Quality by Design and Quality Risk Management projects .
Use of statistical tools is one of the pillars for the science-based approach required by regulatory agencies and in general in Life Science industry.
The aim is to design, optimize and control processes and products in order to increase knowledge, minimize variability and maximize robustness.
These tools provide a scientific rational base for decision-making process and can be very effective for an easy answer to several common problems in development and manufacturing.
Some of the most common Statistical Tools used by PTM are:
- Design of Experiments (DoE),
- Multivariate Data Analysis,
- Regression Correlation,
- ANOVA – MANOVA – ANOM,
- Process capability analysis (Cp Pp Cpk PPk),
- Acceptable Quality Limit (AQL),
- Control Charts,
- Modeling & Simulation,
- Measuring System Analysis (MSA) – Gauge R&R,
- Reliability assessment,