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...
Computer Software Assurance (CSA): The FDA’s New Approach to CSV
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...
User Acceptance Testing: Tools of the Trade
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...
How to Conduct Effective User Acceptance Testing
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...