AssurX Blog
Straight talk for regulated industries.
Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Risk management remains a strong focus of the FDA. A revised FDA guidance offers new details and hones the scope previewing the agency's pilot test of a risk-based system to track phar [...]
CIP Training Management Programs Impacted by NERC Requirements
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 [...]
Part I: Enterprise Quality Management System Selection Best Practices
Editor's Note: In this two-part series, you'll learn common pitfalls to avoid and the most effective ways to select an Enterprise Quality Management system. Selecting an enterprise qua [...]
Document Management Problems Threaten Pharmaceutical Manufacturers
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 [...]
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.
