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Quality Management

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.

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 [...]

25 08, 2022

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?

By Stephanie Ojeda|2023-03-09T00:38:13+00:00August 25th, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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

10 08, 2022

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

Overcoming Common Challenges of Customer Quality Complaint Handling

By Stephanie Ojeda|2022-08-10T07:42:52+00:00August 10th, 2022|FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

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

20 07, 2022

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

By Stephanie Ojeda|2024-12-31T23:16:44+00:00July 20th, 2022|Document Management, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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

28 07, 2020

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

Prioritize QMS Process Automation or Risk Failure

By AssurX Blog|2020-07-28T07:50:20+00:00July 28th, 2020|Complaint Management, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management, Risk Management|

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

16 05, 2017

How Will Real-World Evidence Impact 2017 FDA Guidances?
How Will Real-World Evidence Impact 2017 FDA Guidances?

How Will Real-World Evidence Impact 2017 FDA Guidances?

By AssurX Blog|2024-07-01T22:24:36+00:00May 16th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The Advanced Medical Technology Association (AdvaMed) wants the Food and Drug A [...]

8 05, 2017

CDRH Report: Quality Management Insights For Medical Device Manufacturers
CDRH Report: Quality Management Insights For Medical Device Manufacturers

CDRH Report: Quality Management Insights For Medical Device Manufacturers

By AssurX Blog|2024-07-01T22:26:04+00:00May 8th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management|

FDA's Center for Devices and Radiological Health (CDRH) provided a glowing self [...]