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Quality Management System

AssurX Quality Management Systems (QMS) provide comprehensive solutions to automate and streamline compliance processes. Our platform enhances visibility and control, ensuring adherence to industry standards like ISO 9001 and FDA regulations. Experience seamless integration and real-time insights to improve quality management across your organization.

20 11, 2025

Why Life Sciences Companies Choose CDMOs with a Digital QMS
Why Life Sciences Companies Choose CDMOs with a Digital QMS

Why Life Sciences Companies Choose CDMOs with a Digital QMS

By Stephanie Ojeda|2025-12-04T22:12:09+00:00November 20th, 2025|CDMO, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

When I worked as a supplier quality team lead, I spent a lot of time auditing s [...]

11 11, 2025

Improving the Supplier Corrective Action Request Process with the QMS
Improving the Supplier Corrective Action Request Process with the QMS

Improving the Supplier Corrective Action Request Process with the QMS

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

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

By Tamar June|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 [...]

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 [...]

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 [...]

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 [...]