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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.

12 12, 2024

Using Your QMS to Support cGMP Compliance
Using Your QMS to Support cGMP Compliance

Using Your QMS to Support cGMP Compliance

By Stephanie Ojeda|2025-03-18T09:13:16+00:00December 12th, 2024|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In FY 2023, the majority of warning letters issued to pharmaceutical manufactur [...]

5 12, 2024

AI in Medical Device Manufacturing: How It’s Transforming an Industry
AI in Medical Device Manufacturing: How It’s Transforming an Industry

AI in Medical Device Manufacturing: How It’s Transforming an Industry

By Stephanie Ojeda|2025-04-04T01:31:15+00:00December 5th, 2024|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In April 2018, the U.S. Food and Drug Administration (FDA) approved the first A [...]

21 11, 2024

FDA Inspection Expectations in 2025
FDA Inspection Expectations in 2025

FDA Inspection Expectations in 2025

By Stephanie Ojeda|2025-04-04T02:22:07+00:00November 21st, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspect [...]

14 11, 2024

Critical Aspects of Quality Management Systems: Focusing on the Validation Process
Critical Aspects of Quality Management Systems: Focusing on the Validation Process

Critical Aspects of Quality Management Systems: Focusing on the Validation Process

By Victoria Alestra|2025-04-04T02:21:19+00:00November 14th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In regulated industries like pharmaceuticals, medical devices, and food manufac [...]

30 10, 2024

Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?
Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?

Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?

By Stephanie Ojeda|2025-04-04T02:28:32+00:00October 30th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rul [...]

24 10, 2024

5 Places to Use a FMEA in Your Quality Process
5 Places to Use a FMEA in Your Quality Process

5 Places to Use a FMEA in Your Quality Process

By Stephanie Ojeda|2025-04-04T01:32:06+00:00October 24th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Before any road trip, it makes sense to check your tire pressure along with lev [...]

9 10, 2024

The Role of Technology in Supporting ALCOA Principles: Strengthening Data Integrity in Life Sciences with Quality Management Software
The Role of Technology in Supporting ALCOA Principles: Strengthening Data Integrity in Life Sciences with Quality Management Software

The Role of Technology in Supporting ALCOA Principles: Strengthening Data Integrity in Life Sciences with Quality Management Software

By Stephanie Ojeda|2025-04-04T02:28:48+00:00October 9th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In the highly regulated world of life sciences, data integrity is not optional [...]

29 08, 2024

Ways to Influence Stakeholder Buy-In During the CAPA Process
Ways to Influence Stakeholder Buy-In During the CAPA Process

Ways to Influence Stakeholder Buy-In During the CAPA Process

By Stephanie Ojeda|2025-04-04T01:28:11+00:00August 29th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

How can a quality manager secure stakeholder engagement and hold individuals ac [...]

22 08, 2024

CAPA is a Process, Not a Project: 3 Key Strategies for Success
CAPA is a Process, Not a Project: 3 Key Strategies for Success

CAPA is a Process, Not a Project: 3 Key Strategies for Success

By Stephanie Ojeda|2025-04-04T01:30:11+00:00August 22nd, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

The challenge of the quality manager is to convince stakeholders of their respo [...]

15 08, 2024

Overcoming Deviations and Non-Conformances in Manufacturing: The Power of Automating Quality and Compliance
Overcoming Deviations and Non-Conformances in Manufacturing: The Power of Automating Quality and Compliance

Overcoming Deviations and Non-Conformances in Manufacturing: The Power of Automating Quality and Compliance

By Stephanie Ojeda|2025-04-04T02:25:59+00:00August 15th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Manufacturers widely view process improvement frameworks like Lean as the solut [...]