Quality Management

The “Quality Management” category at AssurX provides a comprehensive look into effective strategies and tools for optimizing quality processes. This section covers essential topics such as process improvement, compliance integration, and performance measurement. By leveraging these resources, organizations can enhance their quality management systems, ensuring consistent product quality and operational efficiency. AssurX offers the expertise and solutions necessary to drive continuous improvement and maintain high standards across industries.

14 03, 2017

Cybersecurity Management Expectations Clarified By FDA
Cybersecurity Management Expectations Clarified By FDA

Cybersecurity Management Expectations Clarified By FDA

By AssurX Blog|2017-03-14T11:01:57+00:00March 14th, 2017|Archives, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

The FDA has made it abundantly clear that it expects medical device manufacturer [...]

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 [...]

30 01, 2017

Risk Management Best Practices for Cybersecurity Compliance
Risk Management Best Practices for Cybersecurity Compliance

Risk Management Best Practices for Cybersecurity Compliance

By AssurX Blog|2017-01-30T01:59:17+00:00January 30th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

A new FDA guidance concerning risk management helps medical device manufacturers [...]

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 [...]

31 12, 2016

Part I: Enterprise Quality Management System Selection Best Practices

By AssurX Blog|2016-12-31T09:58:14+00:00December 31st, 2016|Archives, Quality Management, Regulatory Compliance Management, Risk Management|

Editor's Note: In this two-part series, you'll learn common pitfalls to avoid an [...]

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 [...]

16 12, 2016

Risk Management + Adverse Event Reporting: FDA Guidance
Risk Management + Adverse Event Reporting: FDA Guidance

Risk Management + Adverse Event Reporting: FDA Guidance

By AssurX Blog|2016-12-16T10:21:33+00:00December 16th, 2016|Archives, eMDR, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Risk management and adverse event reporting protocols for medical device manufac [...]