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Risk-Based Validation

Validation risk assessment is a structured and documented approach for assessing risks in a computerized system, as well as for equipment, instruments, and processes.

Risk-based Validation

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 for 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 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

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)

ValGenesis Validation Lifecycle Management System Modules

Risk-Based Validation is a fully integrated module for ValGenesis VLMS, the most complete digital validation system.

Schedule a demo

Reach out to schedule a free, personal demo of the ValGenesis VLMS. We’ll show you our product in-depth and share our experience to identify the perfect solution for your organization.

Schedule a Demo