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

AssurX Blog

Straight talk for regulated industries.

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 th [...]

2810, 2021

AssurX Further Enhances its QMS Validation Solutions Portfolio

October 28th, 2021|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Focus on the future of validation and customized validation services drive further efficiencies MORGAN HILL, CA - October 26, 2021 – AssurX, Inc. (AssurX), a leader in quality and comp [...]

2110, 2021

How to Use the 8D Method for Investigations

October 21st, 2021|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Each day, quality leaders run across all types of problems. Fortunately, some can be corrected immediately. However, others need further investigation, such as a 5 Why analysis. Furthe [...]

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