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.

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

6 Common Reasons External Quality Audits Fail

Stephanie Ojeda2024-03-26T20:24:48+00:00January 12th, 2023|

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

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

Root Cause Analysis Tools: Which Should You Use?

Stephanie Ojeda2024-01-13T02:12:13+00:00January 3rd, 2023|

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

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

8 Essential CAPA KPIs to Measure

Stephanie Ojeda2024-07-01T21:28:46+00:00November 15th, 2022|

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

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

Finding the Root Cause: Where Manufacturers Go Wrong

Stephanie Ojeda2024-03-04T21:11:44+00:00November 2nd, 2022|

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

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

Stephanie Ojeda2024-01-13T02:20:40+00:00October 12th, 2022|

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

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

Tracy Orlick2022-10-05T06:31:55+00:00October 5th, 2022|

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

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

Understanding ALCOA+ Principles and Data Integrity for Pharma

Stephanie Ojeda2024-03-26T20:20:37+00:00September 22nd, 2022|

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

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

Pharmaceutical Warning Letters Reveal CGMP Failures

Stephanie Ojeda2022-09-15T08:35:21+00:00September 15th, 2022|

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

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

Stephanie Ojeda2024-01-13T01:22:12+00:00September 1st, 2022|

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

EU MDR & IVDR Regulation: Where Does the Guidance Stand?
EU MDR & IVDR Regulation: Where Does the Guidance Stand?

EU MDR & IVDR Regulation: Where Does the Guidance Stand?

Stephanie Ojeda2023-03-09T00:38:13+00:00August 25th, 2022|

Companies marketing devices in the European Union are facing a perfect storm of [...]