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.

5 Pillars of Modern Quality Management System Webinar – AssurX
5 Pillars of Modern Quality Management System Webinar – AssurX

5 Pillars of Modern Quality Management System Webinar – AssurX

AssurX Blog2024-07-01T22:22:31+00:00July 7th, 2017|

AssurX hosted a live webinar on July 20, 2017, at 11:00 a.m. PST exploring the 5 [...]

Five Form Design Mistakes To Avoid When Automating Your QMS
Five Form Design Mistakes To Avoid When Automating Your QMS

Five Form Design Mistakes To Avoid When Automating Your QMS

Sal Lucido2017-06-20T09:18:56+00:00June 20th, 2017|

Automated process management systems are the workhorses of every modern company. [...]

Medical Device Manufacturers Warned For CAPA Non-Compliance
Medical Device Manufacturers Warned For CAPA Non-Compliance

Medical Device Manufacturers Warned For CAPA Non-Compliance

AssurX Blog2023-02-27T19:48:41+00:00June 13th, 2017|

Three recent warning letters from the Center for Device and Radiological Health [...]

FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus
FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus

FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus

AssurX Blog2017-05-30T11:50:41+00:00May 30th, 2017|

After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batc [...]

How Will Real-World Evidence Impact 2017 FDA Guidances?
How Will Real-World Evidence Impact 2017 FDA Guidances?

How Will Real-World Evidence Impact 2017 FDA Guidances?

AssurX Blog2024-07-01T22:24:36+00:00May 16th, 2017|

The Advanced Medical Technology Association (AdvaMed) wants the Food and Drug A [...]

CDRH Report: Quality Management Insights For Medical Device Manufacturers
CDRH Report: Quality Management Insights For Medical Device Manufacturers

CDRH Report: Quality Management Insights For Medical Device Manufacturers

AssurX Blog2024-07-01T22:26:04+00:00May 8th, 2017|

FDA's Center for Devices and Radiological Health (CDRH) provided a glowing self [...]

Prioritize QMS Process Automation or Risk Failure
Prioritize QMS Process Automation or Risk Failure

Prioritize QMS Process Automation or Risk Failure

AssurX Blog2024-07-24T18:19:34+00:00April 17th, 2017|

A common pitfall in QMS process automation occurs with a poorly planned process [...]

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 [...]