Blog2022-01-15T20:42:38+00:00

AssurX Blog

Straight talk for regulated industries.

601, 2022

AssurX Promotes Kathryn Wagner to Vice President, Industry Solutions, Energy & Utilities

January 6th, 2022|AssurX News + Success Stories, Energy & Utilities Industry, NERC Compliance, Regulatory Compliance Management|

Morgan Hill, CA., January 6, 2022 – AssurX, Inc., a leader in enterprise quality management and regulatory compliance software, today announced the promotion of Kathryn Wagner to Vice [...]

401, 2022

Quality Risk Management: A Proven 4-Step Process

January 4th, 2022|FDA Regulated Industries, Quality Management, Regulatory Compliance Management, Risk Management|

There’s no question that quality risk management is becoming an indispensable tool for ensuring compliance across the globe. Risk has become a centerpiece of  ISO standards, as well as [...]

912, 2021

3 Essential Document Control Best Practices for Combination Products

December 9th, 2021|Document Management, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Combination products (CPs) have revolutionized drug delivery and patient care, but their very nature poses unique challenges to manufacturers. When two or more components create a comb [...]

3011, 2021

How to use Decision Trees for Root Cause Analysis

November 30th, 2021|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Risk Management|

Let's start with a scenario that illustrates the methodology behind using decision trees for root cause analysis. The scenario: one morning you notice a dark spot on your driveway wher [...]

1611, 2021

6 Habits of Highly Effective Quality Leaders

November 16th, 2021|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

In Stephen Covey’s 7 Habits of Highly Effective People, the author famously exhorts readers to “begin with the end in mind.” Quality leaders who are looking to get better results shoul [...]

1011, 2021

How to Use FMEA for Root Cause Analysis

November 10th, 2021|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Imagine that you’re a manufacturer of skincare products detecting a spike in complaints about a specific eye cream causing skin irritation. Your initial investigation helps isolate the [...]

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