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.

28 03, 2017

FDA States Clear cGMP Expectations for Combination Products
FDA States Clear cGMP Expectations for Combination Products

FDA States Clear cGMP Expectations for Combination Products

By AssurX Blog|2017-03-28T08:51:56+00:00March 28th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

The Food and Drug Administration (FDA) recently released a final guidance on Cur [...]

20 03, 2017

Avoid QMS Automation Failures with the Right Implementation Team
Avoid QMS Automation Failures with the Right Implementation Team

Avoid QMS Automation Failures with the Right Implementation Team

By AssurX Blog|2024-07-01T22:30:41+00:00March 20th, 2017|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Even after decades of eQMS availability, a staggering number of projects still s [...]

6 03, 2017

Increased QMS Compliance Inspections For International Life Science Manufacturers
Increased QMS Compliance Inspections For International Life Science Manufacturers

Increased QMS Compliance Inspections For International Life Science Manufacturers

By AssurX Blog|2024-03-26T20:22:07+00:00March 6th, 2017|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

International QMS compliance inspections of pharmaceutical and medical device ma [...]

20 02, 2017

Document Management + CGMP Compliance
Document Management + CGMP Compliance

Document Management + CGMP Compliance

By AssurX Blog|2024-06-03T13:48:07+00:00February 20th, 2017|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Data integrity within your document management process is a critical component o [...]

14 02, 2017

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

Quality Management Efforts: 2017 CDER Guidance Agenda Impact

By AssurX Blog|2017-02-14T10:09:27+00:00February 14th, 2017|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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

23 01, 2017

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

Tougher Quality Management Enforcement By FDA In 2017

By AssurX Blog|2017-01-23T10:06:32+00:00January 23rd, 2017|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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

16 01, 2017

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

Risk Management + Quality Metrics Reporting: Revised FDA Guidance

By AssurX Blog|2017-01-16T12:48:28+00:00January 16th, 2017|Archives, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

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

19 12, 2016

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

Document Management Problems Threaten Pharmaceutical Manufacturers

By AssurX Blog|2016-12-19T17:33:07+00:00December 19th, 2016|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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

14 12, 2016

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

By AssurX Blog|2016-12-14T15:08:22+00:00December 14th, 2016|Archives, FDA Regulated Industries, Pharmaceutical Industry, Regulatory Compliance Management, Risk Management|

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.

8 11, 2016

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

Weak CAPA Programs Hit Globally by FDA Warnings

By AssurX Blog|2016-11-08T14:40:29+00:00November 8th, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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.