BLOG Finalized: EU Publishes GMP Annex 1 Revision The EU has published its long-anticipated revised GMP Annex 1 for the manufacturing of sterile drug products. Learn more
BLOG Root Cause Essentials: Unleash the Power of Your Mind with Mind Mapping Mind mapping is a great way to evolve your team's thoughts and bring them to life to spark the creative thought process of finding solutions to problems. Learn more
BLOG 5 Steps to Performing an Effective Root Cause Analysis Conducting a root cause analysis (RCA) is an essential problem-solving method used to isolate and identify concerns. RCA goes beyond simple cause and effect to identify failure points in a process or system. Learn more
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 Shaping the Future of Quality at the RQA Virtual European QA Congress "Transformation is a dramatic change. It is an alteration. It is not doing the same thing we did thirty years ago but now using a computer." Learn more
BLOG Get Ready: The Latest Version of MIR 7.3 Is Coming The EU manufacturer incident report (MIR) v7.3 is set to be published soon. The European commission has provided... Learn more
BLOG Sparta Experts Present Their Insights on Digital Quality Transformation and Supplier Management On March 30th and 31st, Sparta Systems, A Honeywell company, was a proud platinum sponsor of the 5th... Learn more
BLOG It’s Time to Harmonize: What QMSR Means to Medical Device Organizations "When adapting to the new rule, the best advice I can give is to take it section by section and have buy-in from top management." Learn more