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.

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

AssurX Blog2024-03-26T20:22:07+00:00March 6th, 2017|

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

Document Management + CGMP Compliance
Document Management + CGMP Compliance

Document Management + CGMP Compliance

AssurX Blog2024-06-03T13:48:07+00:00February 20th, 2017|

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

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 [...]

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

Risk Management Best Practices for Cybersecurity Compliance

AssurX Blog2017-01-30T01:59:17+00:00January 30th, 2017|

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

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

Risk Management + Adverse Event Reporting: FDA Guidance

AssurX Blog2016-12-16T10:21:33+00:00December 16th, 2016|

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

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.