Can we predict adverse regulatory inspection outcomes for you?
Can we predict adverse regulatory inspection outcomes for you?
Based on our work for the FDA and pharmaceutical industry, we showed the existence of a relationship between operational stability, quality practices, and insepction outcomes. The importance of using operational metrics to preventive identify possible manufacturing quality risk is aknowledged by both regulators and companies.
Our scientific findings have been internationally published:
- 3 reports on the topic of FDA quality metrics reseach, showing the connection between operational metriccs and compliance;
- A scientific article supporting a positive relationship between lean practices and better inspectoin outcomes;
- A scientific article supporting a positive relationship between quality practices and delivery performance;
- A two-year (2022-2023) FDA BAA RiskSurve project to contribute to improve site surveillance with advanced machine learning.
The research findings support our project in the industry. We identify patterns and correlations of your operational KPIs with compliance metrics at drug product and manufacturing establishment level. By combining advanced analytics and our knowledge on quality metrics and quality management matuirty, we can support you in identifying the sites whitin your network that require extra attention and pehaps corporate assistance to successfully complete cGMP inspections. Additionally, we can support you in challenging and further developping your quality management review metrics.
Get in touch to learn from our research and design a tailored project to optimize your quality risk management approach.
For more detailed information and to join forces on this matter, please get in touch!
Matteo Bernasconi
Research Associate
Büro 24-0-238
Dufourstrasse 40a
9000 St Gallen