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.

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 [...]

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 [...]

25 08, 2022

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?

By Stephanie Ojeda|2023-03-09T00:38:13+00:00August 25th, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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

30 06, 2022

EUDAMED Update: What You Need to Know Now
EUDAMED Update: What You Need to Know Now

EUDAMED Update: What You Need to Know Now

By Sal Lucido|2022-06-30T21:11:53+00:00June 30th, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]

21 06, 2022

5 Ways an EQMS Resolves Change Management and Change Control Pains
5 Ways an EQMS Resolves Change Management and Change Control Pains

5 Ways an EQMS Resolves Change Management and Change Control Pains

By Sal Lucido|2024-06-03T13:58:34+00:00June 21st, 2022|FDA Regulated Industries, Manufacturing Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

In the life science industry, adjustments are a necessary element throughout the [...]

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 [...]