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Insights on GMP compliance, data integrity, and quality management for pharma, biotech, and healthcare teams.

18 articles
Expert Insights
Why Is Digitalization Becoming Essential in Pharma?

Why Is Digitalization Becoming Essential in Pharma? Digitalization improves operational efficiency; automated workflows reduce repetitive tasks, accelerate approvals, and streamline investigations. By: Susan Cleary, Parsa Famili (Novatek International), Pedro Jorge (Vita Health), Walter Routh, John O’Neill (StabilityHub) Full Article: Digitized vs. digitalization: what is the difference? What is digitalization? Pharmaceutical manufacturing is one of the…

May 19, 2026 · 2 min read
Expert Insights
Digitized vs. Digitalized: Understanding the Core Difference

Digitized vs Digitalized understanding the core difference. Analog information to digital VS how to use digital information. Digitized vs Digitalized understanding the core difference By: Susan Cleary, Parsa Famili (Novatek International), Pedro Jorge (Vita Health), Walter Routh, John O’Neill (StabilityHub) Digitized vs Digitalization – What is the Difference? – StabilityHub For years, organizations across pharmaceutical,…

May 11, 2026 · 2 min read
Expert Insights
Why Statistics Matter in Stability Studies

Why Do Statistics Matter in Pharmaceutical Stability Studies? Co-Written by: Susan Cleary, Novatek International John O’Neill, StabilityHub In pharmaceutical manufacturing, raw stability data is only valuable when paired with advanced statistical analysis. Automated stability software, like Novatek’s digital solutions, turns laboratory data into actionable insights: 💠Revealing trends 💠Predicting shelf life 💠Identifying risks early in the…

Feb 2, 2026 · 1 min read
Expert Insights
Stability Studies in Pharmaceutical Manufacturing

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 studies help manufacturers understand degradation, support accurate shelf-life predictions, and generate the validated data needed for FDA/ICH regulatory submissions. Today’s leading organizations are adopting…

Jan 16, 2026 · 1 min read
Expert Insights
Stability Testing in Pharma with Optimized Statistics

Stability Testing in Pharma: In pharmaceutical manufacturing, ensuring drug product stability is essential for maintaining GMP compliance, quality control, and long-term patient safety. Robust stability studies help manufacturers understand degradation, support accurate shelf-life predictions, and generate the validated data needed for FDA/ICH regulatory submissions. Today’s leading organizations are adopting automation-enabled stability management, predictive analytics, and…

Nov 26, 2025 · 1 min read
Resources
Whitepaper: Doing Digital or Being Digital

Doing Digital or Being Digital? How vertical business applications are providing enormous advantages in pharmaceutical manufacturing & quality operations. At Novatek we are committed to excellence in both software and service. But more than that, we take pride in supporting, supplying, and servicing our clients, with a commitment to Quality. As such we are constantly…

Dec 11, 2024 · 1 min read