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.

28 04, 2022

What is a Quality Management Review and Why Do You Need Them?
What is a Quality Management Review and Why Do You Need Them?

What is a Quality Management Review and Why Do You Need Them?

By AssurX Blog|2024-03-26T20:17:31+00:00April 28th, 2022|FDA Regulated Industries, Quality Management, Regulatory Compliance Management|

This is the first installment of a two-part series focusing on the importance of [...]

20 04, 2022

Understanding FDA Alignment of ISO 13485 with Quality System Regulation
Understanding FDA Alignment of ISO 13485 with Quality System Regulation

Understanding FDA Alignment of ISO 13485 with Quality System Regulation

By AssurX Blog|2024-03-04T21:30:05+00:00April 20th, 2022|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]

7 04, 2022

FDA Warning Letters Highlight Food Safety Compliance Issues
FDA Warning Letters Highlight Food Safety Compliance Issues

FDA Warning Letters Highlight Food Safety Compliance Issues

By AssurX Blog|2024-06-25T18:19:13+00:00April 7th, 2022|FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management|

The U.S. Food and Drug Administration (FDA) has issued dozens of warning letters [...]

31 03, 2022

miraDry Implements AssurX Quality Management and Regulatory Compliance Software
miraDry Implements AssurX Quality Management and Regulatory Compliance Software

miraDry Implements AssurX Quality Management and Regulatory Compliance Software

By Tracy Orlick|2024-01-13T02:06:41+00:00March 31st, 2022|Complaint Management, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leader [...]

31 03, 2022

How an EQMS can Reduce CAPA and Complaint Observation Trends
How an EQMS can Reduce CAPA and Complaint Observation Trends

How an EQMS can Reduce CAPA and Complaint Observation Trends

By AssurX Blog|2025-05-07T23:13:18+00:00March 31st, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

As we move through 2022, we look forward to new opportunities, new challenges, [...]

24 03, 2022

5 Tips for Turning GMP Audits from an Adversarial to a Cooperative Process
5 Tips for Turning GMP Audits from an Adversarial to a Cooperative Process

5 Tips for Turning GMP Audits from an Adversarial to a Cooperative Process

By Sal Lucido|2022-03-24T07:27:10+00:00March 24th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

This article is part two of a two-part series focused on GMP quality audit manag [...]

17 03, 2022

Remote Quality Audits for Regulated Companies Come of Age
Remote Quality Audits for Regulated Companies Come of Age

Remote Quality Audits for Regulated Companies Come of Age

By Sal Lucido|2025-01-01T00:01:28+00:00March 17th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

This article is part one of a two-part series focused on GMP quality audit mana [...]

3 03, 2022

How to Conduct Remote Supplier Quality Audits in a QMS
How to Conduct Remote Supplier Quality Audits in a QMS

How to Conduct Remote Supplier Quality Audits in a QMS

By AssurX Blog|2022-03-08T14:47:33+00:00March 3rd, 2022|FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Since the Covid pandemic, regulators and notified bodies have been doing more re [...]

24 02, 2022

Trend Watch: 2022 and Beyond Will see Maturation of Internal Control Programs
Trend Watch: 2022 and Beyond Will see Maturation of Internal Control Programs

Trend Watch: 2022 and Beyond Will see Maturation of Internal Control Programs

By Kathryn Wagner|2024-07-16T22:55:59+00:00February 24th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Technology, Politics, Climate, and the Coronavirus will Drive Maturation of Int [...]

9 02, 2022

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

7 Benefits of Quality Risk Management in the EQMS

By Sal Lucido|2024-03-04T21:20:32+00:00February 9th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

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