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.

15 12, 2022

FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls
FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls

FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls

By Stephanie Ojeda|2024-06-25T18:23:15+00:00December 15th, 2022|FDA Regulated Industries, Quality Management, Regulatory Compliance Management|

Alignment with the Food Safety Modernization Act (FSMA) is necessary for manufac [...]

29 11, 2022

How Hybrid Audits Can Help MDR Compliance in the European Union
How Hybrid Audits Can Help MDR Compliance in the European Union

How Hybrid Audits Can Help MDR Compliance in the European Union

By Stephanie Ojeda|2022-11-29T08:48:10+00:00November 29th, 2022|eMDR, EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The shortage of notified bodies (NB) in the European Union is a key challenge fo [...]

15 11, 2022

8 Essential CAPA KPIs to Measure
8 Essential CAPA KPIs to Measure

8 Essential CAPA KPIs to Measure

By Stephanie Ojeda|2024-07-01T21:28:46+00:00November 15th, 2022|Corrective Action (CAPA), FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Corrective and preventive action (CAPA) is a core function in any quality manag [...]

2 11, 2022

Finding the Root Cause: Where Manufacturers Go Wrong
Finding the Root Cause: Where Manufacturers Go Wrong

Finding the Root Cause: Where Manufacturers Go Wrong

By Stephanie Ojeda|2024-03-04T21:11:44+00:00November 2nd, 2022|FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Finding the root cause of a manufacturing quality issue prevents unsafe or poor [...]

12 10, 2022

5 Strategies to Improve Quality Incident Management and Root Cause Analysis
5 Strategies to Improve Quality Incident Management and Root Cause Analysis

5 Strategies to Improve Quality Incident Management and Root Cause Analysis

By Stephanie Ojeda|2024-01-13T02:20:40+00:00October 12th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Imagine you’re doing a pre-shipment inspection on multiple pallets containing pr [...]

5 10, 2022

AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables
AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables

AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables

By Tracy Orlick|2022-10-05T06:31:55+00:00October 5th, 2022|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

RENO, NEVADA, UNITED STATES, October 4, 2022 -- AssurX, a leader in quality mana [...]

29 09, 2022

5 Building Blocks You Need for a Quality 4.0 Foundation
5 Building Blocks You Need for a Quality 4.0 Foundation

5 Building Blocks You Need for a Quality 4.0 Foundation

By Stephanie Ojeda|2024-03-04T21:12:48+00:00September 29th, 2022|Complaint Management, Document Management, Manufacturing Industries, Quality Management|

Market changes and disruptions such as the global pandemic are driving companies [...]

22 09, 2022

Understanding ALCOA+ Principles and Data Integrity for Pharma
Understanding ALCOA+ Principles and Data Integrity for Pharma

Understanding ALCOA+ Principles and Data Integrity for Pharma

By Stephanie Ojeda|2024-03-26T20:20:37+00:00September 22nd, 2022|FDA Regulated Industries, Manufacturing Industries, Pharmaceutical Industry, Quality Management|

Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) curre [...]

15 09, 2022

Pharmaceutical Warning Letters Reveal CGMP Failures
Pharmaceutical Warning Letters Reveal CGMP Failures

Pharmaceutical Warning Letters Reveal CGMP Failures

By Stephanie Ojeda|2022-09-15T08:35:21+00:00September 15th, 2022|FDA Regulated Industries, Manufacturing Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. [...]

1 09, 2022

Why an EQMS is Essential for FDA Remote Regulatory Assessments
Why an EQMS is Essential for FDA Remote Regulatory Assessments

Why an EQMS is Essential for FDA Remote Regulatory Assessments

By Stephanie Ojeda|2024-01-13T01:22:12+00:00September 1st, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The global pandemic brought an unexpected change – FDA remote regulatory assessm [...]