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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
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 preview [...]
CIP Training Management Programs Impacted by NERC Requirements
Conducting a cybersecurity training management program gap analysis is critical for regulated utilities to ensure NERC c [...]
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 E [...]
Document Management Problems Threaten Pharmaceutical Manufacturers
Document management problems could soon impact the momentum in the number and speed of drug approvals for the pharmaceut [...]
Risk Management + Adverse Event Reporting: FDA Guidance
Risk management and adverse event reporting protocols for medical device manufacturers have been addressed by new FDA gu [...]
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.
