Regulatory Compliance Management

The “Regulatory Compliance Management” category at AssurX is dedicated to helping organizations navigate the complex landscape of regulatory requirements. This section provides practical tools and expert insights to ensure adherence to industry standards and regulations. It covers a range of topics, including compliance strategy development, risk assessment, and the integration of compliance management systems. By exploring these resources, professionals can streamline their compliance processes and mitigate risks effectively. AssurX equips you with the knowledge and solutions needed to maintain compliance and drive operational excellence.

Tougher Quality Management Enforcement By FDA In 2017
Tougher Quality Management Enforcement By FDA In 2017

Tougher Quality Management Enforcement By FDA In 2017

AssurX Blog2017-01-23T10:06:32+00:00January 23rd, 2017|

Quality management, always an FDA focus during inspections, could become even mo [...]

Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Risk Management + Quality Metrics Reporting: Revised FDA Guidance

Risk Management + Quality Metrics Reporting: Revised FDA Guidance

AssurX Blog2017-01-16T12:48:28+00:00January 16th, 2017|

Risk management remains a strong focus of the FDA. A revised FDA guidance offers [...]

CIP Training Management Programs Impacted by NERC Requirements
CIP Training Management Programs Impacted by NERC Requirements

CIP Training Management Programs Impacted by NERC Requirements

AssurX Blog2024-01-13T01:52:58+00:00January 9th, 2017|

Conducting a cybersecurity training management program gap analysis is critical [...]

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.

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."