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—to validate/verify a system or process. Validation risk assessment is a structured and documented approach to assessing risks in a computerized system, as well as for equipment, instruments, and processes.
Our VLMS comes equipped with convenient Risk Assessment tools that provide our clients with several significant benefits:
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.
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.
Users can 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 needed for the system to be considered validated or verified can be determined.
Users can conduct risk assessment at the functional or requirement level.
Functional risk assessment allows users to determine the amount of testing required (based on risk level).
