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Clear, actionable intelligence for regulated industries.

Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.

2001, 2022

Making the Business Case for an Electronic Quality Management System

January 20th, 2022|FDA Regulated Industries, Quality Management, Regulatory Compliance Management|

Part 2 of a three-part EQMS blog series If you’re responsible for establishing or improving your electronic quality management system (QMS), brace yourself for many challenges. One of [...]

1301, 2022

5 Reasons Why an Enterprise Quality Management System (EQMS) is Imperative

January 13th, 2022|FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Many companies are still clinging to paper-based and unconnected electronic processes. As a result, they are at risk of compromising product quality and compliance. But there are other [...]

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 [...]

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