AssurX Blog
Straight talk for regulated industries.
Risk Management + Adverse Event Reporting: FDA Guidance
Risk management and adverse event reporting protocols for medical device manufacturers have been addressed by new FDA guidance. Producing and controlling electronic records will be cri [...]
Risk Management Programs: What The Latest Wave of HIPAA Fines Mean
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
If compliance with the North American Reliability Corporation (NERC) Reliability Standards wasn’t complex enough, registered utilities must also factor in the regulatory nuances of the [...]
Weak CAPA Programs Hit Globally by FDA Warnings
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?
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
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."
