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.

China Addresses Life Sciences Regulatory Compliance Concerns
China Addresses Life Sciences Regulatory Compliance Concerns

China Addresses Life Sciences Regulatory Compliance Concerns

AssurX Blog2017-04-10T13:44:24+00:00April 10th, 2017|

China has often faced criticism for lax regulation of drug and medical device ma [...]

FDA Warning Letters Emphasize Document Control System Compliance
FDA Warning Letters Emphasize Document Control System Compliance

FDA Warning Letters Emphasize Document Control System Compliance

AssurX Blog2025-04-03T01:32:10+00:00April 3rd, 2017|

First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]

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

FDA States Clear cGMP Expectations for Combination Products

AssurX Blog2017-03-28T08:51:56+00:00March 28th, 2017|

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

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

AssurX Blog2024-07-01T22:30:41+00:00March 20th, 2017|

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

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

Cybersecurity Management Expectations Clarified By FDA

AssurX Blog2017-03-14T11:01:57+00:00March 14th, 2017|

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

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 [...]