AssurX Blog
Straight talk for regulated industries.
Root Cause Analysis and CAPA: Creating a Closed-Loop Process
This article examines why a closed-loop root cause analysis (RCA) and corrective and preventive action (CAPA) process is critical, as well as the key steps it should cover. In addition [...]
AssurX Announces Migration to Switch for Cloud-Based QMS and Compliance Platforms
Powerful Private Cloud Delivers Enterprise Performance and Security MORGAN HILL, CA, USA, August 19, 2021 /-- AssurX, Inc. (AssurX), a leader in quality management and regulatory compl [...]
How to Automate Food and Beverage Quality Management
Data buried in file cabinets. Forgotten emails. Poorly documented processes. Unfortunately, these practices are not uncommon in food and beverage companies. As a result, poor food and [...]
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 [...]