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.

22 10, 2025

The Hidden Cost of Fragmented QMS Systems in Life Sciences
The Hidden Cost of Fragmented QMS Systems in Life Sciences

The Hidden Cost of Fragmented QMS Systems in Life Sciences

By Stephanie Ojeda|2025-10-22T14:55:24+00:00October 22nd, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Implementing a new quality management system (QMS) is no small task, especially [...]

16 10, 2025

5 Benefits of Quality Risk Management in the EQMS
5 Benefits of Quality Risk Management in the EQMS

5 Benefits of Quality Risk Management in the EQMS

By Stephanie Ojeda|2025-10-16T20:08:13+00:00October 16th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Regulators and standards organizations are increasingly requiring manufacturers [...]

9 10, 2025

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

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

By Stephanie Ojeda|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
Building a Strong EQMS Foundation: Why Document Control and Training Come First

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

By Stephanie Ojeda|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
FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations

FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations

By Stephanie Ojeda|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
5 Essential Elements Shared by Leading Supplier Quality Management Systems

5 Essential Elements Shared by Leading Supplier Quality Management Systems

By Stephanie Ojeda|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
Why Quality Audits Are Critical for Compliance in FDA and ISO Environments

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

By Stephanie Ojeda|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
QMS Validation: How CSA Reduces Documentation Without Increasing Risk

QMS Validation: How CSA Reduces Documentation Without Increasing Risk

By Victoria Alestra|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 [...]

26 06, 2025

Supplier Scorecards vs. Spreadsheets: Risks of Manual Tracking
Supplier Scorecards vs. Spreadsheets: Risks of Manual Tracking

Supplier Scorecards vs. Spreadsheets: Risks of Manual Tracking

By Stephanie Ojeda|2025-06-26T14:08:20+00:00June 26th, 2025|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

Spreadsheets are usually the first tool used to manage suppliers, and the first [...]

17 06, 2025

QMS Software: When to Configure and When to Customize
QMS Software: When to Configure and When to Customize

QMS Software: When to Configure and When to Customize

By Stephanie Ojeda|2025-06-17T15:25:23+00:00June 17th, 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 it comes to managing quality and compliance in today’s regulated industries [...]