FDA’s CDRH is planning on releasing a guidance on Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software in 2020 (applicable to non-product CSV only). Currently, it is on their “A” list. There has been a lot of industry chatter about this particular guidance related to computer validation. Everyone is eager to know about FDA’s current position on computer validation. So much has changed in the last two decades and we still don’t know what FDA’s current thinking is when it comes to the “cloud”. FDA has surely managed to keep us behind a “dark cloud”!

PostNagesh NamaOctober 31, 2019FDA's CSA, FDA GuidanceComment

How does Continuous Validation Stack Up against FDA's new CSA?

Publication, PostNagesh NamaApril 13, 2019FDA's CSA, FDA GuidanceComment

What's the Scoop on FDA's Upcoming CSA (Computer Software Assurance) Guidance?

Publication, PostNagesh NamaApril 13, 2019FDA Guidance, FDA's CSAComment