Applying risk assessment procedures to validation is a highly effective means of ensuring that all critical requirements are tested – with the appropriate level of documentation – in order for a system or process to be considered as validated or verified. Validation risk assessment is a structured and documented approach to assessing risks in a computerized system, equipment, instrument and process.
- ValGenesis supports most of the commonly adopted risk management processes including FMEA. End users are able to mirror their current risk assessment procedures without customization of the system.
- ValGenesis allows users to conduct risk assessment at the computer system, equipment, instrument, or process level. Based on the risk profile, the required level of validation or verification effort can be determined in order for the system to be considered validated or verified.
- ValGenesis also provides the ability to conduct risk assessment at the functional or requirement levels
- Functional risk assessment provides users with the ability to determine the amount of testing that is required based on the risk level at the requirement or function level.