AssurX Archives: Historical Insights on Compliance

The “Archives” category at AssurX serves as a repository of valuable past content. Providing access to a comprehensive collection of articles. Insights and updates related to quality management and compliance. This section enables users to explore historical content and gain insights from previous discussions. And track the evolution of industry trends and AssurX’s solutions. Whether you’re looking for specific information or browsing for inspiration. The archives offer a wealth of knowledge to support your quality and compliance efforts.

Part I: Enterprise Quality Management System Selection Best Practices

AssurX Blog2016-12-31T09:58:14+00:00December 31st, 2016|

Editor's Note: In this two-part series, you'll learn common pitfalls to avoid an [...]

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 [...]

Risk Management Programs: What The Latest Wave of HIPAA Fines Mean
Risk Management Programs: What The Latest Wave of HIPAA Fines Mean

Risk Management Programs: What The Latest Wave of HIPAA Fines Mean

AssurX Blog2016-12-14T15:08:22+00:00December 14th, 2016|

The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the fine tsunami? Don't bet on it.

Utility NERC Compliance Programs Challenged by NERC’s New Risk-Based Approach
Utility NERC Compliance Programs Challenged by NERC’s New Risk-Based Approach

Utility NERC Compliance Programs Challenged by NERC’s New Risk-Based Approach

AssurX Blog2025-10-02T21:43:40+00:00November 30th, 2016|

If compliance with the North American Reliability Corporation (NERC) Reliability [...]

Weak CAPA Programs Hit Globally by FDA Warnings
Weak CAPA Programs Hit Globally by FDA Warnings

Weak CAPA Programs Hit Globally by FDA Warnings

AssurX Blog2016-11-08T14:40:29+00:00November 8th, 2016|

Life sciences companies around the world better make sure their Corrective and Preventive Action (CAPA) plans are in good shape before an inspector comes calling.

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.

Ukraine Cyberattack Represents Wake-up Call for America’s Utility Grid
Ukraine Cyberattack Represents Wake-up Call for America’s Utility Grid

Ukraine Cyberattack Represents Wake-up Call for America’s Utility Grid

AssurX Blog2024-07-16T21:25:57+00:00October 24th, 2016|

Still think all of those concerns about cybersecurity protections on the electric grid are overblown? Try asking the 225,000 people in the Ukraine whose power was cut last December by a Russian hacking group that calls itself "Sandworm."

What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card
What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card

What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card

AssurX Blog2023-02-27T20:08:48+00:00October 24th, 2016|

If working with the FDA sometimes feels like reading tea leaves the Quarterly Update on Medical Device Performance Goals gives us more than our usual share of relatively hard data.

How Strong is Your QMS Program? New International Meddev Rules Challenge Complacent Organizations
How Strong is Your QMS Program? New International Meddev Rules Challenge Complacent Organizations

How Strong is Your QMS Program? New International Meddev Rules Challenge Complacent Organizations

AssurX Blog2025-04-04T02:24:31+00:00October 14th, 2016|

It's time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management (QMS) processes - especially document management and change control - will be critical to comply with such a disparate group of regulations working with so many regulatory bodies.