Mobility and Validation: Back to the Future
In 2015, the U.S. FDA issues new guidance for Mobile Medical Applications. Given the widespread adoption and use of mobile technologies, new guidance was necessary to understand how the FDA looks at these devices and enforces them. While the guidance was prospective in looking at technologies considered to be medical devices, it also pointed out […]
5 Ways to Revive Your CSV Validation Process in 2018
If you are like most veteran validation engineers, you have been conducting validation exercises the same old way. You have been gathering user requirements, conducting risk assessments, developing test scripts (most often on paper) and delivering validation documentation and due diligence as required by current global regulations. Validation processes have not changed very much over […]
