FDA Compliance Software Solutions by AssurX

AssurX’s FDA Compliance Software automates quality management processes, ensuring adherence to FDA regulations like 21 CFR Part 11. Our platform integrates with enterprise systems, enhancing visibility and control over compliance activities. Experience streamlined workflows and real-time insights to maintain high compliance standards.

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 [...]

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 [...]

Successful QMS Implementation Requires Clearly Defined Processes
Successful QMS Implementation Requires Clearly Defined Processes

Successful QMS Implementation Requires Clearly Defined Processes

AssurX Blog2025-07-16T18:23:16+00:00April 11th, 2017|

Industry-leading quality management systems (QMS) are built with clearly defined [...]

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 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 [...]

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 [...]

Is Your Change Control Program Ready for FDA 510(k) Scrutiny?
Is Your Change Control Program Ready for FDA 510(k) Scrutiny?

Is Your Change Control Program Ready for FDA 510(k) Scrutiny?

AssurX Blog2025-10-02T21:52:01+00:00October 31st, 2016|

A trio of FDA 510(k) guidances demonstrate how important it is for medical device manufacturers to get a firm grip on document management and change control – especially when working within the Third Party (TP) Review Program or trying to determine if a medical device change warrants a new 510(k). The agency is attempting to make it easier on device makers if they understand how to work within the new system.