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.

Quality Management Efforts: 2017 CDER Guidance Agenda Impact
Quality Management Efforts: 2017 CDER Guidance Agenda Impact

Quality Management Efforts: 2017 CDER Guidance Agenda Impact

AssurX Blog2017-02-14T10:09:27+00:00February 14th, 2017|

Quality management efforts could be impacted by what appears to be an aggressive [...]

Tougher Quality Management Enforcement By FDA In 2017
Tougher Quality Management Enforcement By FDA In 2017

Tougher Quality Management Enforcement By FDA In 2017

AssurX Blog2017-01-23T10:06:32+00:00January 23rd, 2017|

Quality management, always an FDA focus during inspections, could become even mo [...]

Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Risk Management + Quality Metrics Reporting: Revised FDA Guidance

Risk Management + Quality Metrics Reporting: Revised FDA Guidance

AssurX Blog2017-01-16T12:48:28+00:00January 16th, 2017|

Risk management remains a strong focus of the FDA. A revised FDA guidance offers [...]

Document Management Problems Threaten Pharmaceutical Manufacturers
Document Management Problems Threaten Pharmaceutical Manufacturers

Document Management Problems Threaten Pharmaceutical Manufacturers

AssurX Blog2016-12-19T17:33:07+00:00December 19th, 2016|

Document management problems could soon impact the momentum in the number and sp [...]

Risk Management Programs: What The Latest Wave of HIPAA Fines Mean
Risk Management Programs: What The Latest Wave of HIPAA Fines Mean

Risk Management Programs: What The Latest Wave of HIPAA Fines Mean

AssurX Blog2016-12-14T15:08:22+00:00December 14th, 2016|

The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the fine tsunami? Don't bet on it.

Weak CAPA Programs Hit Globally by FDA Warnings
Weak CAPA Programs Hit Globally by FDA Warnings

Weak CAPA Programs Hit Globally by FDA Warnings

AssurX Blog2016-11-08T14:40:29+00:00November 8th, 2016|

Life sciences companies around the world better make sure their Corrective and Preventive Action (CAPA) plans are in good shape before an inspector comes calling.

Cloud for quality and compliance management: A primer for life sciences companies
Cloud for quality and compliance management: A primer for life sciences companies

Cloud for quality and compliance management: A primer for life sciences companies

AssurX Blog2024-03-26T20:18:20+00:00September 27th, 2016|

Here's what life sciences companies moving their quality and compliance management tools to the cloud can expect.

Improving FDA Reviews of Combination Products
Improving FDA Reviews of Combination Products

Improving FDA Reviews of Combination Products

AssurX Blog2025-10-02T22:00:07+00:00November 3rd, 2015|

The FDA and Intercenter Consultations Just a few short weeks ago, Robert Califf [...]

US Drug Shortage Hits Patients, Pharmacies the Hardest

AssurX Blog2015-08-17T11:17:53+00:00August 17th, 2015|

Patrick Stone, President, TradeStoneQA The corner drug store is not currently [...]

Will New User Fees Fuel More FDA Inspections?
Will New User Fees Fuel More FDA Inspections?

Will New User Fees Fuel More FDA Inspections?

AssurX Blog2015-07-15T08:25:57+00:00July 15th, 2015|

For FY 2016, FDA is requesting $4.9 billion to support our essential functions a [...]