AssurX Blog
Straight talk for regulated industries.
Effectively Managing Data Integrity for CGMP
Data integrity is a key component in making informed decisions within any organization. Reliable data promotes good decisions. Unmanaged and inaccurate data will have consequences on a [...]
5 Commonalities of Enterprise Supplier Quality Management Systems
Global-scale events have tested the bounds of a supply chain system. The coronavirus, for example, has made it clear how critical an efficient supply chain is for continuity and surviv [...]
Don’t take your foot off the gas on EU MDR implementation
The coronavirus has had a massive impact on the medical device industry. As a consequence, the European Commission has accepted a proposal to postpone the EU MDR application date. Thi [...]
A Message from our CEO Concerning Coronavirus (COVID-19)
The worldwide coronavirus (COVID-19) has challenged our way of life and AssurX extends our thoughts to the people who have been affected. We also share our gratitude for the individual [...]
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 [...]
