Enterprise Quality Management Software by AssurX

AssurX’s Enterprise Quality Management Software (EQMS) automates and harmonizes quality processes on a secure platform. Our EQMS adapts to evolving business needs, providing a comprehensive solution for managing compliance and quality issues across industries. Benefit from seamless integration, flexibility, and scalability to improve operational efficiency and regulatory adherence.

2 11, 2022

Finding the Root Cause: Where Manufacturers Go Wrong
Finding the Root Cause: Where Manufacturers Go Wrong

Finding the Root Cause: Where Manufacturers Go Wrong

By Stephanie Ojeda|2024-03-04T21:11:44+00:00November 2nd, 2022|FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Finding the root cause of a manufacturing quality issue prevents unsafe or poor [...]

12 10, 2022

5 Strategies to Improve Quality Incident Management and Root Cause Analysis
5 Strategies to Improve Quality Incident Management and Root Cause Analysis

5 Strategies to Improve Quality Incident Management and Root Cause Analysis

By Stephanie Ojeda|2024-01-13T02:20:40+00:00October 12th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Imagine you’re doing a pre-shipment inspection on multiple pallets containing pr [...]

5 10, 2022

AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables
AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables

AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables

By Tracy Orlick|2022-10-05T06:31:55+00:00October 5th, 2022|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

RENO, NEVADA, UNITED STATES, October 4, 2022 -- AssurX, a leader in quality mana [...]

29 09, 2022

5 Building Blocks You Need for a Quality 4.0 Foundation
5 Building Blocks You Need for a Quality 4.0 Foundation

5 Building Blocks You Need for a Quality 4.0 Foundation

By Stephanie Ojeda|2024-03-04T21:12:48+00:00September 29th, 2022|Complaint Management, Document Management, Manufacturing Industries, Quality Management|

Market changes and disruptions such as the global pandemic are driving companies [...]

22 09, 2022

Understanding ALCOA+ Principles and Data Integrity for Pharma
Understanding ALCOA+ Principles and Data Integrity for Pharma

Understanding ALCOA+ Principles and Data Integrity for Pharma

By Stephanie Ojeda|2024-03-26T20:20:37+00:00September 22nd, 2022|FDA Regulated Industries, Manufacturing Industries, Pharmaceutical Industry, Quality Management|

Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) curre [...]

15 09, 2022

Pharmaceutical Warning Letters Reveal CGMP Failures
Pharmaceutical Warning Letters Reveal CGMP Failures

Pharmaceutical Warning Letters Reveal CGMP Failures

By Stephanie Ojeda|2022-09-15T08:35:21+00:00September 15th, 2022|FDA Regulated Industries, Manufacturing Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. [...]

1 09, 2022

Why an EQMS is Essential for FDA Remote Regulatory Assessments
Why an EQMS is Essential for FDA Remote Regulatory Assessments

Why an EQMS is Essential for FDA Remote Regulatory Assessments

By Stephanie Ojeda|2024-01-13T01:22:12+00:00September 1st, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The global pandemic brought an unexpected change – FDA remote regulatory assessm [...]

3 03, 2022

How to Conduct Remote Supplier Quality Audits in a QMS
How to Conduct Remote Supplier Quality Audits in a QMS

How to Conduct Remote Supplier Quality Audits in a QMS

By AssurX Blog|2022-03-08T14:47:33+00:00March 3rd, 2022|FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Since the Covid pandemic, regulators and notified bodies have been doing more re [...]

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 [...]

27 01, 2022

AssurX Names Kevin Tom as Director of Product Management for Life Sciences & Manufacturing Industries
AssurX Names Kevin Tom as Director of Product Management for Life Sciences & Manufacturing Industries

AssurX Names Kevin Tom as Director of Product Management for Life Sciences & Manufacturing Industries

By AssurX Blog|2024-12-31T23:10:16+00:00January 27th, 2022|AssurX News + Success Stories, FDA Regulated Industries, Quality Management, Regulatory Compliance Management|

Morgan Hill, CA., January 26, 2022 -- AssurX, Inc. (AssurX), a leader in quality [...]