In the pharmaceutical, biotech, and medical device industries, GxP regulations—including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and related standards—ensure product quality, safety, and reliability. Artificial...
Have you ever wondered how the digital tools and software we use every day become so intuitive and user-friendly? The secret lies in a process called usability testing. While traditionally employed in software design, its applications extend to any user-facing tool....
A risk-based approach is a cornerstone of modern GxP validation approaches. It focuses resources where they matter most, ensuring patient safety and product quality while optimizing efficiency. GAMP 5 (Good Automated Manufacturing Practice) is a widely recognized...
During a 2011 review of medical device quality data, the FDA’s Center for Devices and Radiological Health (CDRH) noticed a variety of widespread manufacturing risks that were impacting product quality. A few of these risks included: An industry focus on regulatory...
Software testing and validation are essential when implementing any system designed to process, store, visualize or manage data. Most of this testing (e.g., functional testing, regression testing, security testing, integration testing, etc.) is done by IT members and...
According to a report from Forbes, 25 percent of technology projects fail outright; 20 to 25 percent don't show any return on investment; and as much as 50 percent need massive reworking by the time they're finished. Why is this the case? It is a complex question...