CSV to CSA: A Paradigm Shift in Computerized Systems’ Approaches – or not?
No more validation.
CSV is a thing of the past.
These are just some of the attention-grabbing headlines I’ve seen in various blogs and LinkedIn posts over the last 12 months about Computer System Assurance (CSA), and the reality couldn’t be more different.
The U.S. FDA originally targeted their Case for Quality initiative (2011) at improving medical device quality and usability for patient safety. More recently, FDA’s Center for Devices and Radiological Health has sponsored an industry pilot team1 under the CSA title to improve Computer System Validation (CSV) approaches, as the existing practices were identified as a barrier to the adoption of new technologies.
But, really, how much difference can there be between Validation and Assurance?