What the Yellow Book Updates for 2025 Means for Auditing Organizations
The U.S. Government Accountability Office (GAO) issued the 2024 revision of Gov [...]
Why Change Control is Important: Tips for Manufacturers
Change is a constant in manufacturing, and is both necessary for innovation and [...]
The Hidden ROI of Complaint Management
Formal complaint management is a requirement in regulated industries such as med [...]
9 Strategies for Effective Internal Audits
As the age-old saying goes, sunlight is the best disinfectant. In the field of q [...]
AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)
AssurX will be exhibiting at this year’s ASQ World Conference on Quality & [...]
Why Manufacturers are Integrating EHS and Quality
Quality management and environmental, health, and safety (EHS) have traditionall [...]
How to Establish Sustainable Validation for FDA & EU Compliance
Software validation is historically one of the most difficult compliance activit [...]
QMS Configuration vs. Out-of-the-Box: Real-World Considerations
When evaluating an automated QMS, the question to invest in configuration vs. ou [...]
EUDAMED Update: What You Need to Know Now
The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]
How to Conduct Remote Supplier Quality Audits in a QMS
Since the Covid pandemic, regulators and notified bodies have been doing more re [...]
