Pharmaceutical Industry

The “Pharmaceutical Industry” category at AssurX focuses on addressing challenges and opportunities within the sector. This section provides insights into quality management, regulatory compliance, and process optimization for drug development and manufacturing. It emphasizes ensuring product safety and efficacy. Discover strategies to navigate complex regulations and enhance operational efficiency. AssurX offers tools and knowledge to help pharmaceutical professionals maintain compliance, improve quality, and drive innovation.

30 01, 2024

The Hidden ROI of Complaint Management
The Hidden ROI of Complaint Management

The Hidden ROI of Complaint Management

By Stephanie Ojeda|2025-03-18T09:28:08+00:00January 30th, 2024|Audit Management, Corrective Action (CAPA), Document Management, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Formal complaint management is a requirement in regulated industries such as med [...]

17 01, 2024

9 Strategies for Effective Internal Audits
9 Strategies for Effective Internal Audits

9 Strategies for Effective Internal Audits

By Stephanie Ojeda|2025-03-18T09:28:40+00:00January 17th, 2024|Audit Management, Corrective Action (CAPA), Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

As the age-old saying goes, sunlight is the best disinfectant. In the field of q [...]

19 01, 2023

An Overview of the FDA Draft of CSA Guidance for Quality Systems
An Overview of the FDA Draft of CSA Guidance for Quality Systems

An Overview of the FDA Draft of CSA Guidance for Quality Systems

By Stephanie Ojeda|2023-01-19T10:01:40+00:00January 19th, 2023|Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

In September 2022, the (FDA) released draft computer systems assurance (CSA) gui [...]

12 01, 2023

6 Common Reasons External Quality Audits Fail
6 Common Reasons External Quality Audits Fail

6 Common Reasons External Quality Audits Fail

By Stephanie Ojeda|2024-03-26T20:24:48+00:00January 12th, 2023|Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

In FDA and ISO environments, quality audits are a process of examination and sub [...]

3 01, 2023

Root Cause Analysis Tools: Which Should You Use?
Root Cause Analysis Tools: Which Should You Use?

Root Cause Analysis Tools: Which Should You Use?

By Stephanie Ojeda|2024-01-13T02:12:13+00:00January 3rd, 2023|Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Root cause analysis is a common weak spot in manufacturing, causing numerous qua [...]

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 [...]

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 [...]