Risk-Based Validation

Supports most commonly adopted risk management processes including FMEA

Supports decision tree driven risk assessment

Users can mirror current risk assessment procedures without customization of the system

Users can conduct risk assessment for the computer systems, equipment, instruments and processes

Supports with built-in best practices for risk management, clients can leverage these prebuilt risk models, templates and decision trees who want to improve the current risk management process

Based on the risk profile, the required level of validation or verification effort needed for the system to be considered validated or verified can be determined

Users can conduct risk assessment at the functional or system level

Functional risk assessment allows users to determine the amount of testing required (based on risk level)