Focused on the critical role of digitalization, statistical analysis, and GxP compliance in pharmaceutical manufacturing. These articles highlight how Novatek International’s validated digital solutions help pharmaceutical manufacturers improve data integrity, regulatory compliance, and operational efficiency. Regulatory-readiness (21 CFR Part 11) for laboratory management auditing, drives Novatek International to prioritize drug stability through accurate shelf life predictions, automated trending and statistical analysis, and reporting.
Susan B. Cleary, B.Cs, EMBA. Director of Product Development Why Do Statistics Matter in Pharmaceutical Stability Studies? Co-Written by: Susan Cleary, Novatek International John O’Neill, StabilityHub In pharmaceutical…
The Importance of Stability Studies in Pharmaceutical Manufacturing In pharmaceutical manufacturing, ensuring drug product stability is essential for maintaining GMP compliance, quality control, and long-term patient safety. Robust stability…
Susan Cleary Susan B. Cleary, B.Cs, EMBA. Director of Product Development Stability Testing in Pharma: In pharmaceutical manufacturing, ensuring drug product stability is essential for maintaining GMP compliance, quality control,…