Computer System Assurance
CSA?proposes “a set of activities or actions?to be performed to give confidence that the software functions as intended and meets the organization’s needs’’. These activities can include?solution selection analysis, vendor history?and?data?(which can be reused!), market performance data, installation activities, factory acceptance and risk-based testing.
Risk-based assurance, applying the right level of risk to patient safety and/or product quality and/or Data integrity.
Taking prior assurance activities into account and upstream / downstream risk controls.
Benefits of a CSA approach