AssurX Blog
Straight talk for regulated industries.
A Successful QMS Implementation Requires Clearly Defined Processes
This blog is the second of a three-part series on QMS implementation best practices. Read the first blog article for a best practices approach for organizing and managing a QMS impleme [...]
Avoid QMS Implementation Failures with the Right Team
This blog it the first of a three-part series on QMS implementation best practices. Sign up for our blog to receive parts two and three. Even after decades of eQMS availability, a stag [...]
How Risk-Based Testing is Revolutionizing Computer System Validation
We live in a world where speed is vital to success. Patients and consumers expect products to be of good quality and available when needed. Therefore, companies must oblige in the exp [...]
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 [...]
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 [...]