AssurX Blog
Straight talk for regulated industries.
The Six C’s of a Modern Complaint Management System 2020
Regulators such as FDA, European Commission (EC), ISO 13485 require a product complaint management system that is effective for resolving product quality issues and improving patient [...]
Human Error is a Precipitator for Root Cause Analysis, Not Blame
Have you ever been part of a process that had a failure or two? Perhaps you’ve been on a team that missed a deadline because something didn’t go as expected. Most of us have. In many c [...]
Assurx2020 Further Modernizes Efficiencies In Automating Quality Management
Morgan Hill, CA., January 22, 2020, – AssurX, Inc., a leader in enterprise quality management and regulatory compliance software, announced AssurX2020, an expansion of enhancements in [...]
AssurX Releases Manufacturing Incident Report Solution for EU MDR Report Automation for Medical Device Manufacturers
Morgan Hill, CA., February 5, 2020 – AssurX, Inc., a leader in enterprise quality management and regulatory compliance software, announced the availability of its Manufacturing Inciden [...]
Configuration vs. Customization for Enterprise QMS Software
Experience shows that out-of-the-box configured software only works for businesses with limited resources or standardized business processes. Unfortunately, quality management systems [...]
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 [...]
