AssurX Blog
Straight talk for regulated industries.
How to Simplify CAPA Management with a Cloud-Based QMS
Corrective and preventive action (CAPA) violations are the most frequently cited non-compliance in FDA 483 inspection observations. In 2020, nearly 200 violations were cited among medi [...]
How COVID-19 Is Driving the Shift from Paper to Cloud QMS
When COVID-19 hit in 2020, companies around the world suddenly found themselves at the mercy of processes designed for the previous era of manufacturing. Not surprisingly, cloud QMS be [...]
Deviation vs. Nonconformance: What’s the Difference?
Recent headlines over wasted COVID-19 vaccines reveal shocking instances of lab workers not following key procedures, leading to contamination of millions of doses. Is this event a dev [...]
Connecting Your Document Control System for Employee Training Management
When companies implement an enterprise quality management system (EQMS), one of the first places they often start is with a corrective action solution. This makes business sense when t [...]
All Roads Lead to ISO 13485: The Global Context
As regulations and standards evolve, one trend is continually sharpening in focus. ISO 13485 for medical device quality management systems is becoming the international standard for st [...]
Are FDA Warning Letters and 483 Observations About to Spike?
The number of U.S. Food and Drug Administration (FDA) inspections dropped dramatically in 2020, with the agency postponing most onsite visits to limit COVID-19 risks. The number of FDA [...]
