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

AssurX Blog

Straight talk for regulated industries.

502, 2020

AssurX Releases Manufacturing Incident Report Solution for EU MDR Report Automation for Medical Device Manufacturers

February 5th, 2020|AssurX News + Success Stories, eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Regulatory Compliance Management|

Morgan Hill, CA., February 5, 2020 – AssurX, Inc., a leader in enterprise quality management and regulatory compliance software, announced the availability of its Manufacturing Inciden [...]

2301, 2020

Configuration vs. Customization for Enterprise QMS Software

January 23rd, 2020|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

Experience shows that out-of-the-box configured software only works for businesses with limited resources or standardized business processes. Unfortunately, quality management systems [...]

1912, 2019

Best Practices for 21 CFR Part 11 Compliance

December 19th, 2019|Document Management, eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

With more modern-day compliance enforcement, life science manufacturers and distributors are opting to digitize manual, paper processes with electronic transactions. Electronic records [...]

1112, 2019

Looking Ahead: 2020 Life Sciences Technology Trends

December 11th, 2019|Document Management, eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management, Uncategorized|

The Life Sciences industry has always been fast-paced and competitive. Changes are influenced by the regulatory landscape, a need for lifesaving products as well as therapies and scie [...]

312, 2019

Elements of a Modern and Efficient Change Management System

December 3rd, 2019|Energy & Utilities Industry, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

An efficiently designed change management system clearly defines how strategies, procedures, and technologies will be applied to address changes in the business environment. Implementi [...]

1811, 2019

Top 10 Traits of World Quality Management Leaders

November 18th, 2019|AssurX News + Success Stories, Manufacturing Industries, Quality Management, Regulatory Compliance Management, Risk Management, Uncategorized|

It’s World Quality Month (WQM) and that means taking time to reflect and recognize the impact that good quality management has on products and processes. What is good quality?  We’ll l [...]

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