AssurX Blog
Straight talk for regulated industries.
Implementing Global Data Privacy Compliance Plans
As businesses continue to embrace digital transformation, cloud computing has emerged as a cornerstone of modern IT strategies. While the cloud offers unparalleled scalability, flexib [...]
Mastering Quality: Proven Risk Mitigation Strategies for Flawless Manufacturing
Risk mitigation is crucial for manufacturing quality products because it helps manufacturers identify, assess, and manage potential risks before they lead to defects, inefficiencies, [...]
How to Achieve Manufacturing Quality Compliance Success: Apply Automation
FDA inspections and subsequent actions all come down to product quality. Quality system failures result in non-compliances that FDA inspectors target during their inspections. If ther [...]
Overcoming the Challenges of Medical Device Complaint Handling with AI: How 3Analytics Leads the Way
The medical device industry plays a pivotal role in global healthcare, delivering innovations that save lives and improve patient outcomes. However, with such high stakes, ensuring th [...]
Using Your QMS to Support cGMP Compliance
In FY 2023, the majority of warning letters issued to pharmaceutical manufacturers by the U.S. Food and Drug Administration cited current good manufacturing practice (cGMP) violations [...]
AI in Medical Device Manufacturing: How It’s Transforming an Industry
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first AI-powered diagnostic system, a software program used to detect diabetes-related vision loss. Since then, [...]
