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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
Best Practices for 21 CFR Part 11 Compliance
With more modern-day compliance enforcement, life science manufacturers and distributors are opting to digitize manual, [...]
Looking Ahead: 2020 Life Sciences Technology Trends
The Life Sciences industry has always been fast-paced and competitive. Changes are influenced by the regulatory landsca [...]
Elements of a Modern and Efficient Change Management System
An efficiently designed change management system clearly defines how strategies, procedures, and technologies will be ap [...]
Top 10 Traits of World Quality Management Leaders
It’s World Quality Month (WQM) and that means taking time to reflect and recognize the impact that good quality manageme [...]
Have You Transitioned to Quality 4.0?
Quality 4.0 focuses on a collaborative approach to quality to ensure that quality is top of mind throughout an organizat [...]
QMS Validation 101: SDLC vs. STLC Methodologies and Relationships
Validation is integral part of Good Manufacturing Practices (GMPs) and covers almost every aspect of manufacturing and p [...]
