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

AssurX Blog

Straight talk for regulated industries.

2102, 2020

Human Error is a Precipitator for Root Cause Analysis, Not Blame

February 21st, 2020|Document Management, eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management, SaaS & Cloud Computing|

Have you ever been part of a process that had a failure or two? Perhaps you’ve been on a team that missed a deadline because something didn’t go as expected. Most of us have. In many c [...]

1002, 2020

Assurx2020 Further Modernizes Efficiencies In Automating Quality Management

February 10th, 2020|AssurX News + Success Stories, Document Management, eMDR, Energy & Utilities Industry, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, NERC Compliance, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management, SaaS & Cloud Computing|

Morgan Hill, CA., January 22, 2020, – AssurX, Inc., a leader in enterprise quality management and regulatory compliance software, announced AssurX2020, an expansion of enhancements in [...]

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 [...]

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