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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.

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 [...]

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|2024-03-26T20:26:06+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, a [...]

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 [...]