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.

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 [...]

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

EUDAMED Update: What You Need to Know Now

Sal Lucido2022-06-30T21:11:53+00:00June 30th, 2022|

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

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

Sal Lucido2024-06-03T13:58:34+00:00June 21st, 2022|

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

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

AssurX Blog2024-03-04T21:30:05+00:00April 20th, 2022|

The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]

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

Tracy Orlick2025-10-03T04:17:01+00:00March 31st, 2022|

MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leade [...]

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

AssurX Blog2025-05-07T23:13:18+00:00March 31st, 2022|

As we move through 2022, we look forward to new opportunities, new challenges, [...]