NEWS
Validation Gaps That Kill Launch Timelines
Validation is a critical component of quality management that ensures medical devices are safe, effective, and compliant. For MedTech innovators, gaps in validation ...more
Quality Culture
December 25, 2025•5 min read
Case Study: QMS Gap Assessment and Integration
The QMS gap assessment and integration project demonstrated how systematic evaluation, scientific documentation practices, and targeted training can achieve compliance with PIC/S PE 009 and Annex 3 re... ...more
Quality Culture
December 08, 2025•6 min read
Improve Performance in Key Risk Areas: Data Integrity, Deviations, and Documentation
QSN Academy provides expert guidance and training to help therapeutic goods manufacturers, testing laboratories, and biotechnology companies strengthen performance in these critical areas. ...more
Quality Culture
November 26, 2025•4 min read
Turning Compliance into Growth with Staff Upskilling
Staff upskilling not only ensures regulatory compliance but also builds resilient, capable teams capable of driving innovation, operational efficiency, and long-term organisational success. ...more
Quality Culture ,Quality Training
November 24, 2025•4 min read
How to Foster a Culture of Compliance and Professional Excellence
Establishing a culture where compliance is integrated into daily operations and professional standards are consistently upheld requires more than policies and procedures; it involves deliberate organi... ...more
Quality Culture
November 19, 2025•5 min read
Understand What Is the Risk Management Plan (RMP) and Risk Management File (RMF)
Risk Management Plan (RMP) and the Risk Management File (RMF). Although closely related, they serve different but complementary purposes. Understanding how these fit into your broader quality and regu... ...more
Quality Culture
October 01, 2025•7 min read
