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Life Sciences
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 [...]
Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?
In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rule harmonizing its Quality System Regulat [...]
5 Places to Use a FMEA in Your Quality Process
Before any road trip, it makes sense to check your tire pressure along with levels of engine oil, windshield wiper flui [...]
