Quality Management

The “Quality Management” category at AssurX provides a comprehensive look into effective strategies and tools for optimizing quality processes. This section covers essential topics such as process improvement, compliance integration, and performance measurement. By leveraging these resources, organizations can enhance their quality management systems, ensuring consistent product quality and operational efficiency. AssurX offers the expertise and solutions necessary to drive continuous improvement and maintain high standards across industries.

11 11, 2025

Improving the Supplier Corrective Action Request Process with the QMS

By |2025-11-11T13:32:19+00:00November 11th, 2025|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

When I first started developing supplier quality management programs in pharma m [...]

4 11, 2025

AssurX Promotes Stephanie Ojeda to Vice President, Product Management, Life Sciences and Manufacturing

By |2025-11-04T18:49:46+00:00November 4th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Risk Management|

Reno, NV – November 4, 2025 – AssurX, a leading provider of quality management [...]

9 10, 2025

FSVP Violations Under Fire: FDA’s 2025 Warning Letters and the Listeria Outbreak Exposing Global Food Supply Chain Risk

By |2025-10-09T15:54:29+00:00October 9th, 2025|FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management, Risk Management|

In 2025, the U.S. Food and Drug Administration (FDA) has continued its crackdow [...]

22 09, 2025

Building a Strong EQMS Foundation: Why Document Control and Training Come First

By |2025-09-22T18:16:14+00:00September 22nd, 2025|Corrective Action (CAPA), Document Management, Quality Management, Regulatory Compliance Management|

When organizations implement an enterprise quality management system (EQMS), th [...]

5 08, 2025

FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations

By |2025-08-05T13:51:41+00:00August 5th, 2025|Document Management, eMDR, EU IVDR, EU MDR, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The U.S. Food and Drug Administration (FDA) released an updated guidance docume [...]

28 07, 2025

5 Essential Elements Shared by Leading Supplier Quality Management Systems

By |2025-07-28T16:33:25+00:00July 28th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

Global-scale events have tested the bounds of a supply chain system. The coronav [...]

23 07, 2025

Why Quality Audits Are Critical for Compliance in FDA and ISO Environments

By |2025-07-23T14:48:04+00:00July 23rd, 2025|Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Quality audits are a cornerstone of compliance in FDA and ISO-regulated environ [...]

9 07, 2025

QMS Validation: How CSA Reduces Documentation Without Increasing Risk

By |2025-07-08T20:34:27+00:00July 9th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Documentation has long been at the heart of quality management system (QMS) val [...]

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