Blog2025-03-18T10:11:14+00:00

AssurX Blog

Straight talk for regulated industries.

901, 2017

CIP Training Management Programs Impacted by NERC Requirements

January 9th, 2017|Archives, Energy & Utilities Industry, NERC Compliance, Regulatory Compliance Management|

Conducting a cybersecurity training management program gap analysis is critical for regulated utilities to ensure NERC compliance in 2017 and beyond. Cyber Security Qualifications Bols [...]

1912, 2016

Document Management Problems Threaten Pharmaceutical Manufacturers

December 19th, 2016|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Document management problems could soon impact the momentum in the number and speed of drug approvals for the pharmaceutical industry. FDA’s Office of Generic Drugs (OGD) record Fiscal [...]

1612, 2016

Risk Management + Adverse Event Reporting: FDA Guidance

December 16th, 2016|Archives, eMDR, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

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 [...]

1412, 2016

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

December 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.

3011, 2016

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

November 30th, 2016|Archives, Energy & Utilities Industry, Risk Management|

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 [...]

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