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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
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-complian [...]
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 impro [...]
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 Administra [...]
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 [...]
FDA Inspection Expectations in 2025
The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspections of regulated manufacturers’ facilit [...]
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 operat [...]
