Risk Management Software by AssurX

AssurX Risk Management Software enhances the identification, assessment, and control of risks across enterprises. Our platform integrates with quality management systems to automate risk processes, ensuring compliance with standards like ISO 14971 and ISO 9001. Experience improved visibility and decision-making with real-time risk analysis and reporting.

24 10, 2024

5 Places to Use a FMEA in Your Quality Process
5 Places to Use a FMEA in Your Quality Process

5 Places to Use a FMEA in Your Quality Process

By Stephanie Ojeda|2025-04-04T01:32:06+00:00October 24th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Before any road trip, it makes sense to check your tire pressure along with lev [...]

26 07, 2023

Risk Management in ISO 13485
Risk Management in ISO 13485

Risk Management in ISO 13485

By Stephanie Ojeda|2024-06-03T14:04:45+00:00July 26th, 2023|Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management, Risk Management|

In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue i [...]

15 12, 2022

FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls
FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls

FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls

By Stephanie Ojeda|2024-06-25T18:23:15+00:00December 15th, 2022|FDA Regulated Industries, Quality Management, Regulatory Compliance Management|

Alignment with the Food Safety Modernization Act (FSMA) is necessary for manufac [...]

9 02, 2022

7 Benefits of Quality Risk Management in the EQMS
7 Benefits of Quality Risk Management in the EQMS

7 Benefits of Quality Risk Management in the EQMS

By Sal Lucido|2024-03-04T21:20:32+00:00February 9th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Regulators and standards organizations are increasingly requiring manufacturers [...]

20 01, 2022

Making the Business Case for an Electronic Quality Management System
Making the Business Case for an Electronic Quality Management System

Making the Business Case for an Electronic Quality Management System

By Sal Lucido|2024-03-26T22:18:35+00:00January 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 [...]

4 01, 2022

Quality Risk Management: A Proven 4-Step Process
Quality Risk Management: A Proven 4-Step Process

Quality Risk Management: A Proven 4-Step Process

By Sal Lucido|2022-01-04T09:37:45+00:00January 4th, 2022|FDA Regulated Industries, Quality Management, Regulatory Compliance Management, Risk Management|

There’s no question that quality risk management is becoming an indispensable to [...]

1 06, 2020

How Risk-Based Testing is Revolutionizing Computer System Validation
How Risk-Based Testing is Revolutionizing Computer System Validation

How Risk-Based Testing is Revolutionizing Computer System Validation

By AssurX Blog|2024-01-13T02:37:12+00:00June 1st, 2020|FDA Regulated Industries, Manufacturing Industries, Quality Management|

We live in a world where speed is vital to success. Patients and consumers expec [...]

21 02, 2020

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

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

By AssurX Blog|2024-06-03T13:33:05+00:00February 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 b [...]

3 10, 2017

Take Action for ISO 13485:2016 Certification Preparedness
Take Action for ISO 13485:2016 Certification Preparedness

Take Action for ISO 13485:2016 Certification Preparedness

By Sal Lucido|2017-10-03T10:29:52+00:00October 3rd, 2017|FDA Regulated Industries, Regulatory Compliance Management, Risk Management|

ISO 13485 has undergone its first major overhaul of manufacturing system require [...]

30 01, 2017

Risk Management Best Practices for Cybersecurity Compliance
Risk Management Best Practices for Cybersecurity Compliance

Risk Management Best Practices for Cybersecurity Compliance

By AssurX Blog|2017-01-30T01:59:17+00:00January 30th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

A new FDA guidance concerning risk management helps medical device manufacturers [...]

Risk Management software