Blog
Continuous Manufacturing QMS: FDA Guidance and Quality System Considerations
TLDR Continuous manufacturing (CM) produces pharmaceutical product in an uninterrupted stream rather than in discrete batches. FDA has issued guidance
Digital Twin in Quality Management: Applications for Medical Device and Pharma QMS
TLDR A digital twin is a virtual model of a physical system, process, or product that is continuously updated with
Quality 4.0: How Industry 4.0 Technologies Are Reshaping Quality Management
TLDR Quality 4.0 applies Industry 4.0 technologies, AI, IoT, digital twins, cloud computing, and advanced analytics, to quality management. For
Supplier Performance Metrics: What to Track and How to Drive Continuous Improvement
TLDR Supplier performance metrics give regulated companies the data they need to manage supply chain risk before it reaches the
Material Review Board (MRB): Purpose, Process, and FDA Requirements
TLDR A Material Review Board (MRB) is the cross-functional body that decides what happens to nonconforming material, accept, rework, scrap,
Field Safety Corrective Action (FSCA): EU MDR Requirements and How to Execute
What Is a Field Safety Corrective Action? A Field Safety Corrective Action is any action taken by a medical device