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.

How Hybrid Audits Can Help MDR Compliance in the European Union
How Hybrid Audits Can Help MDR Compliance in the European Union

How Hybrid Audits Can Help MDR Compliance in the European Union

Stephanie Ojeda2022-11-29T08:48:10+00:00November 29th, 2022|

The shortage of notified bodies (NB) in the European Union is a key challenge fo [...]

8 Essential CAPA KPIs to Measure
8 Essential CAPA KPIs to Measure

8 Essential CAPA KPIs to Measure

Stephanie Ojeda2024-07-01T21:28:46+00:00November 15th, 2022|

Corrective and preventive action (CAPA) is a core function in any quality manag [...]

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

Finding the Root Cause: Where Manufacturers Go Wrong

Stephanie Ojeda2024-03-04T21:11:44+00:00November 2nd, 2022|

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

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

Stephanie Ojeda2024-01-13T02:20:40+00:00October 12th, 2022|

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

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

Tracy Orlick2022-10-05T06:31:55+00:00October 5th, 2022|

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

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

Stephanie Ojeda2024-03-04T21:12:48+00:00September 29th, 2022|

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

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

Understanding ALCOA+ Principles and Data Integrity for Pharma

Stephanie Ojeda2024-03-26T20:20:37+00:00September 22nd, 2022|

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

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

Pharmaceutical Warning Letters Reveal CGMP Failures

Stephanie Ojeda2022-09-15T08:35:21+00:00September 15th, 2022|

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

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

Stephanie Ojeda2024-01-13T01:22:12+00:00September 1st, 2022|

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

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

AssurX Blog2022-03-08T14:47:33+00:00March 3rd, 2022|

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