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Life Sciences
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 ava [...]
Effectively Managing Data Integrity for CGMP
Data integrity is a key component in making informed decisions within any organization. Reliable data promotes good deci [...]
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 [...]
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 [...]
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 effec [...]
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 bec [...]
