BLOG Post-Market Surveillance: UDI Compliance for Class I Devices Moves Forward with New Deadline The FDA established the UDI system to identify medical devices sold in the United States from manufacturing through patient use, which would ultimately modernize post-market surveillance. Learn more
BLOG Uncovering the Root Cause and Overcoming Challenges Along the Way Root cause analysis (RCA) is the process of drilling down to find the causes of the problem so corrective and preventive action can be taken. Learn more
BLOG Integration of Quality Management and Manufacturing Automation Systems: The Key to Enabling Quality by Design The benefits of enabling Quality by Design with AI-driven quality operations include connecting AI-enabled quality management and batch automation to provide real-time visibility, using real-time critical process parameter alerts to provide early detection, and more. Learn more
BLOG 7 Macro Trends Affecting Life Sciences Quality Leaders While the life sciences industry faces unprecedented challenges, there are also opportunities to serve the patient like never before, both of which require innovation in their business and product and in their approach to quality. Learn more
BLOG An Overview of AI in Key Quality Management Processes AI-enabled quality management systems can help organizations transform their quality culture and improve digital quality. Learn more
BLOG Quality Challenges Facing the Medical Device Industry Medical device companies need a solution that mitigates quality challenges with supply chain quality management, complaint handling and reporting processes. Learn more
ON-DEMAND A Journey Beyond Proactive Quality: What We Learned at Sparta’s Virtual Series On June 8th, Sparta kicked off its two-day Digital Transformation in Quality virtual series with a welcome keynote... Learn more
BLOG Technology and Quality Data: Is Your Organization Keeping Up? Quality data have a direct impact on operational and economic performance in various areas—from research and development (R&D) to manufacturing, to the supply chain. Learn more
BLOG Paving the Way to Proactive Quality: Tips for a Successful Journey Are you simply reacting to quality events or are you preventing them from occurring in the first place? Learn more