What Should Global Manufacturers Know About the New Import Framework?
What Technologies Are Enabling Continuous Supplier Monitoring?
What Are the FDA’s Latest Expectations for SaMD Submissions?
What Does the FDA Look for During Inspections of Foreign Contract Manufacturers?
What Metrics Define CAPA Effectiveness in Life Sciences Quality Systems?
How ALOCA+ Is Evolving With AI and Digital Systems in 2025?
What Should Global Manufacturers Know About the New Import Framework?
Global manufacturers must treat the U.S. FDA’s Import Alert framework as a dynamic, operational risk-control…
What Technologies Are Enabling Continuous Supplier Monitoring?
Continuous Supplier Monitoring (CSM) has become one of the most important capabilities for life sciences…
What Are the FDA’s Latest Expectations for SaMD Submissions?
The FDA’s expectations for SaMD (Software as a Medical Device) submissions have moved decisively toward…
What Does the FDA Look for During Inspections of Foreign Contract Manufacturers?
The FDA is increasing inspections of foreign contract manufacturers, often without notice. They focus on…
What Metrics Define CAPA Effectiveness in Life Sciences Quality Systems?
CAPA effectiveness is central to product quality, patient safety, and regulatory compliance in life sciences….
How ALOCA+ Is Evolving With AI and Digital Systems in 2025?
In 2025, the principles of ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring,…