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.

13 06, 2017

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

Medical Device Manufacturers Warned For CAPA Non-Compliance

By AssurX Blog|2023-02-27T19:48:41+00:00June 13th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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

30 05, 2017

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

FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus

By AssurX Blog|2017-05-30T11:50:41+00:00May 30th, 2017|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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

16 05, 2017

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?

By AssurX Blog|2024-07-01T22:24:36+00:00May 16th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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

8 05, 2017

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

By AssurX Blog|2024-07-01T22:26:04+00:00May 8th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management|

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

17 04, 2017

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

Prioritize QMS Process Automation or Risk Failure

By AssurX Blog|2024-07-24T18:19:34+00:00April 17th, 2017|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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

10 04, 2017

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

China Addresses Life Sciences Regulatory Compliance Concerns

By AssurX Blog|2017-04-10T13:44:24+00:00April 10th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

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

3 04, 2017

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

FDA Warning Letters Emphasize Document Control System Compliance

By AssurX Blog|2025-04-03T01:32:10+00:00April 3rd, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

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

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 [...]