Quality Management Solutions by AssurX

AssurX’s Quality Management solutions automate and streamline compliance processes, ensuring adherence to industry standards. Our platform provides comprehensive tools for tracking, reporting, and improving quality across your organization. Enhance efficiency and maintain high standards with seamless integration and real-time insights.

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 [...]

EU MDR & IVDR Regulation: Where Does the Guidance Stand?
EU MDR & IVDR Regulation: Where Does the Guidance Stand?

EU MDR & IVDR Regulation: Where Does the Guidance Stand?

Stephanie Ojeda2023-03-09T00:38:13+00:00August 25th, 2022|

Companies marketing devices in the European Union are facing a perfect storm of [...]

Overcoming Common Challenges of Customer Quality Complaint Handling
Overcoming Common Challenges of Customer Quality Complaint Handling

Overcoming Common Challenges of Customer Quality Complaint Handling

Stephanie Ojeda2022-08-10T07:42:52+00:00August 10th, 2022|

From food and beverage to electronics to CPG, there’s not a single type of manuf [...]

FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System
FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System

FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System

Stephanie Ojeda2024-12-31T23:16:44+00:00July 20th, 2022|

As innovation in medical technology increases, potential cybersecurity threats a [...]

Prioritize QMS Process Automation or Risk Failure
Prioritize QMS Process Automation or Risk Failure

Prioritize QMS Process Automation or Risk Failure

AssurX Blog2020-07-28T07:50:20+00:00July 28th, 2020|

This blog is part of a three-part series on proven strategies to help avoid QMS [...]