AssurX Blog
Straight talk for regulated industries.
Best Practices for 21 CFR Part 11 Compliance
With more modern-day compliance enforcement, life science manufacturers and distributors are opting to digitize manual, paper processes with electronic transactions. Electronic records [...]
Looking Ahead: 2020 Life Sciences Technology Trends
The Life Sciences industry has always been fast-paced and competitive. Changes are influenced by the regulatory landscape, a need for lifesaving products as well as therapies and scie [...]
Elements of a Modern and Efficient Change Management System
An efficiently designed change management system clearly defines how strategies, procedures, and technologies will be applied to address changes in the business environment. Implementi [...]
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 management has on products and processes. What is good quality? We’ll l [...]
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 organization. The Quality 4.0 initiative is designed to expand the respon [...]
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 processing activities. Quality Management System (QMS) software v [...]
