AssurX Blog
Straight talk for regulated industries.
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.
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.
