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.

11 04, 2017

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

Successful QMS Implementation Requires Clearly Defined Processes

By AssurX Blog|2025-07-16T18:23:16+00:00April 11th, 2017|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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

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 [...]

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 [...]

19 12, 2016

Document Management Problems Threaten Pharmaceutical Manufacturers
Document Management Problems Threaten Pharmaceutical Manufacturers

Document Management Problems Threaten Pharmaceutical Manufacturers

By AssurX Blog|2016-12-19T17:33:07+00:00December 19th, 2016|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Document management problems could soon impact the momentum in the number and sp [...]

16 12, 2016

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

Risk Management + Adverse Event Reporting: FDA Guidance

By AssurX Blog|2016-12-16T10:21:33+00:00December 16th, 2016|Archives, eMDR, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

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

31 10, 2016

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?

By AssurX Blog|2025-10-02T21:52:01+00:00October 31st, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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.