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.

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 [...]

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|2025-05-13T15:19:43+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 [...]

6 01, 2022

AssurX Promotes Kathryn Wagner to Vice President, Industry Solutions, Energy & Utilities
AssurX Promotes Kathryn Wagner to Vice President, Industry Solutions, Energy & Utilities

AssurX Promotes Kathryn Wagner to Vice President, Industry Solutions, Energy & Utilities

By AssurX Blog|2024-12-31T23:13:46+00:00January 6th, 2022|AssurX News + Success Stories, Energy & Utilities Industry, NERC Compliance, Regulatory Compliance Management|

Morgan Hill, CA., January 6, 2022 – AssurX, Inc., a leader in enterprise quality [...]

23 09, 2021

New FDA Traceability Rules Coming: What the Food & Beverage Industry Needs to Know
New FDA Traceability Rules Coming: What the Food & Beverage Industry Needs to Know

New FDA Traceability Rules Coming: What the Food & Beverage Industry Needs to Know

By AssurX Blog|2024-12-31T23:18:46+00:00September 23rd, 2021|FDA Regulated Industries, Food & Beverage Industry, Quality Management|

In FDA-regulated industries, a single event can lead to widespread change. For e [...]

1 09, 2021

Root Cause Analysis and CAPA: Creating a Closed-Loop Process
Root Cause Analysis and CAPA: Creating a Closed-Loop Process

Root Cause Analysis and CAPA: Creating a Closed-Loop Process

By AssurX Blog|2024-12-31T23:23:15+00:00September 1st, 2021|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

This article examines why a closed-loop root cause analysis (RCA) and corrective [...]