AssurX Blog
Straight talk for regulated industries.
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, [...]
FDA Inspection Expectations in 2025
The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspections of regulated manufacturers’ facilities to identify and address quality system failures. With a high [...]
Critical Aspects of Quality Management Systems: Focusing on the Validation Process
In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated Quality Management System (QMS) is [...]
