Incorporating Risk Traceability into Manufacturing Production Software and Preparing for the Transition from CSV to CSA
Incorporating Risk Traceability into Manufacturing Production Software and Preparing for the Transition from CSV to CSA Intro Over the years, the burden of Computer Systems Validation (CSV) has resulted in medical device manufacturers avoiding implementation of automated manufacturing production systems or upgrading long-outdated versions of software. As part of the FDA’s ‘Case for Quality’ initiative […]