Blog2025-03-18T10:11:14+00:00

AssurX Blog

Straight talk for regulated industries.

109, 2021

Root Cause Analysis and CAPA: Creating a Closed-Loop Process

September 1st, 2021|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

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 [...]

1908, 2021

AssurX Announces Migration to Switch for Cloud-Based QMS and Compliance Platforms

August 19th, 2021|AssurX News + Success Stories, Energy & Utilities Industry, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, SaaS & Cloud Computing|

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 [...]

1808, 2021

How to Automate Food and Beverage Quality Management

August 18th, 2021|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, 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 [...]

1307, 2021

How to Simplify CAPA Management with a Cloud-Based QMS

July 13th, 2021|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Risk Management|

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 [...]

1606, 2021

How COVID-19 Is Driving the Shift from Paper to Cloud QMS

June 16th, 2021|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

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 [...]

806, 2021

Deviation vs. Nonconformance: What’s the Difference?

June 8th, 2021|Complaint Management, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

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 [...]

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