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Inspection Week Shouldn’t Feel Like A Fire Drill
Regulatory inspections shouldn’t require weeks of searching for records, rebuilding audit trails, and pulling teams away from their day-to-day work. This blog explores why organisations are moving from reactive inspection preparation to continuous compliance, and...
Beyond the PPD Label: Clearer Language for Stronger Clinical Trial Transparency Submissions
In this blog, we discuss PPD, what different agencies actually care about, and how to navigate CTT language in an ever-changing regulatory landscape.
What’s New in eQCM 10.01?
With the release of eQCM 10.01, Instem is introducing tighter document control and audit trail integrity for regulated environments.
Introducing Blur™ 2.10: Faster, More Precise Clinical Trial De-Identification
With the release of Blur™ 2.10, Instem is introducing a broad set of enhancements across CSR anonymization, data de-identification, risk simulation, administration, performance, and security.
Mutagenicity Assessment Under ICH M7: Scientific Principles Supporting Pharmaceutical Impurity Risk Assessment
Mutagenicity assessment is the critical first step in pharmaceutical impurity risk evaluation, and this blog explores the scientific principles underpinning robust ICH M7 assessments, from complementary QSAR methodologies and Ames study data to applicability domain...
Strengthening CMC Readiness with In Silico Insight
CMC readiness begins long before IND submission. Explore how early data-driven decision-making, predictive toxicology, and connected workflows can reduce risk, improve data quality, and simplify regulatory preparation throughout the drug development journey.
Webinar Recap: When SEND Quality Matters Most
Our recent webinar, “When SEND Quality Matters Most”, explored the recent FDA communications regarding data quality, why regulatory expectations are shifting, where common issues arise, and how organizations can strengthen confidence before filing SEND datasets...
The Changing Language of Clinical Trial Transparency
This blog examines how clinical trial transparency regulations are evolving and what organizations can do to keep up with expectations.
Webinar Recap: Closing Compliance Gaps with Compliance Builder
Comprehensive electronic recordkeeping is a cornerstone of all laboratory functions in regulated industries, but establishing and maintaining 21 CFR Part 11 compliance is challenging when processes are fragmented across multiple instruments and systems.
