December 8, 2016

Utility NERC Compliance Programs Challenged by New Risk-Based Approach

If compliance with the North American Reliability Corporation (NERC) Reliability Standards wasn’t complex… [more]

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

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… [more]

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

Weak Corrective and Preventive Action (CAPA) Programs Hit Globally by FDA Warnings

  Life sciences companies around the world should make sure their Corrective and Preventive… [more]

Weak Corrective and Preventive Action (CAPA) Programs Hit Globally by FDA Warnings Weak Corrective and Preventive Action (CAPA) Programs Hit Globally by FDA Warnings

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… [more]

Is Your Change Control Program Ready for FDA 510(k) Scrutiny? Is Your Change Control Program Ready for FDA 510(k) Scrutiny?

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

Still think all of those concerns about cybersecurity protections on the electric grid are overblown?… [more]

Ukraine Cyberattack is a Wake-up Call for America’s Utility Grid Ukraine Cyberattack is a Wake-up Call for America's Utility Grid

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

If working with the FDA sometimes feels like reading tea leaves the Quarterly Update on Medical Device… [more]

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

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

It's time to get your compliance programs in order to meet some looming international regulatory compliance… [more]

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

Featured Posts

Utility NERC Compliance Programs Challenged by 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 bulk power system’s (BPS) eight Regional Entities (RE), even as NERC emerges with new risk management expectations. While there is plenty of regulatory – and physi … [Read More...]

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. In the most recent example, St. Joseph Health (SJH) agreed to settle … [Read More...]

Weak Corrective and Preventive Action (CAPA) Programs Hit Globally by FDA Warnings

  Life sciences companies around the world should make sure their Corrective and Preventive Action (CAPA) plans are in good shape before an inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it's clear the agency will focus like a laser on CAPA. The good news is that taking a … [Read More...]

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 de … [Read More...]

Ukraine Cyberattack is a 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." During the hack, Sandworm's savvy experts remotely switched breakers in a way that cut power to users after … [Read More...]

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

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. It's a breath of fresh air, even if the breeze isn't always positive. "Under the new user fee agreement, the FDA has committed to significant improvements for total … [Read More...]

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

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 … [Read More...]

Cloud For Quality And Compliance Management: A Primer For Life Sciences Companies

Companies within the life sciences industry are slowly but surely making the move to the cloud. Virtual computing environments are becoming the most popular, secure and effective way to store data and run applications, so it's no surprise that companies within this industry would want to partake, despite their traditional reticence. Nonetheless, a … [Read More...]

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