Archives | AssurX

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 This section allows users to explore historical content, gain insights from previous discussions, and track the evolution of industry trends and AssurX’s solutions.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.

14 12, 2016

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

By AssurX Blog|2016-12-14T15:08:22+00:00December 14th, 2016|Archives, FDA Regulated Industries, Pharmaceutical Industry, Regulatory Compliance Management, Risk Management|

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.

30 11, 2016

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

By AssurX Blog|2023-03-29T17:04:07+00:00November 30th, 2016|Archives, Energy & Utilities Industry, Risk Management|

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

8 11, 2016

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

Weak CAPA Programs Hit Globally by FDA Warnings

By AssurX Blog|2016-11-08T14:40:29+00:00November 8th, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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.

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|2023-03-08T22:42:36+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.

24 10, 2016

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

By AssurX Blog|2024-07-16T21:25:57+00:00October 24th, 2016|Archives, Energy & Utilities Industry, NERC Compliance, Regulatory Compliance Management, Risk Management|

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."

24 10, 2016

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

By AssurX Blog|2023-02-27T20:08:48+00:00October 24th, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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.

14 10, 2016

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

By AssurX Blog|2025-04-04T02:24:31+00:00October 14th, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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.

27 09, 2016

Cloud for quality and compliance management: A primer for life sciences companies
Cloud for quality and compliance management: A primer for life sciences companies

Cloud for quality and compliance management: A primer for life sciences companies

By AssurX Blog|2024-03-26T20:18:20+00:00September 27th, 2016|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Here's what life sciences companies moving their quality and compliance management tools to the cloud can expect.

19 09, 2016

RAPS Preview: FDA CDRH Director Shuren Talks Priorities
RAPS Preview: FDA CDRH Director Shuren Talks Priorities

RAPS Preview: FDA CDRH Director Shuren Talks Priorities

By AssurX Blog|2023-02-28T15:35:39+00:00September 19th, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

FDA CDRH or Center for Devices and Radiological Health Director Jeff Shuren, MD [...]

5 11, 2015

FDA Eases Up a Bit on Enforcement Gas Pedal as Warning Letters Decline

By AssurX Blog|2015-11-05T11:39:30+00:00November 5th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Medical device warning letters and domestic inspections continue to show a slow [...]