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AssurX Blog

Straight talk for regulated industries.

1409, 2020

AssurX Focuses on Medical Device Compliance at RAPS Convergence 2020

September 14th, 2020|AssurX News + Success Stories, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

AssurX is participating in the first virtual RAPS Convergence Conference currently live through September 16, 2020, in Virtual Booth 610. RAPS Convergence brings together the largest c [...]

408, 2020

Why Consider a Cloud QMS for FRACAS Automation?

August 4th, 2020|FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

Authors: Sal DiIorio, Principal Consultant, Semi-Tech Group Dave Vadas, VP of Special Projects, AssurX   Quality management software by design is built to automate processes for s [...]

2807, 2020

Prioritize QMS Process Automation or Risk Failure

July 28th, 2020|Complaint Management, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management, Risk Management|

This blog is part of a three-part series on proven strategies to help avoid QMS implementation failures.  The first blog article describes the best practices approach to building a QMS [...]

1307, 2020

A Successful QMS Implementation Requires Clearly Defined Processes

July 13th, 2020|Document Management, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

This blog is the second of a three-part series on QMS implementation best practices. Read the first blog article for a best practices approach for organizing and managing a QMS impleme [...]

1307, 2020

Avoid QMS Implementation Failures with the Right Team

July 13th, 2020|FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

This blog it the first of a three-part series on QMS implementation best practices. Sign up for our blog to receive parts two and three. Even after decades of eQMS availability, a sta [...]

106, 2020

How Risk-Based Testing is Revolutionizing Computer System Validation

June 1st, 2020|FDA Regulated Industries, Manufacturing Industries, Quality Management|

We live in a world where speed is vital to success. Patients and consumers expect products to be of good quality and available when needed. Therefore, companies must oblige in the expe [...]

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