Quality Management System Solutions by AssurX

AssurX Quality Management Systems (QMS) provide comprehensive solutions to automate and streamline compliance processes. Our platform enhances visibility and control, ensuring adherence to industry standards like ISO 9001 and FDA regulations. Experience seamless integration and real-time insights to improve quality management across your organization.

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 [...]

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 [...]

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 [...]