CSV VS CSA By Hema Sharma

The FDA'S Case for Quality launched in 2011 stated that the iniyiative was set up to promote implementation of critical- to-quality practices during devices design and Production.

The FDA therefore decided it was time for a new approach. this new approach is computer system assurance CSA.

IT represents a change in the way system are validated. the idea with CSA is to allow organization to focus on regroups testing on area that directly impact patient safety and device Quality.