ValGenesis provides an integrated and flexible risk management framework for documenting and assessing risks, defining controls, defining validation deliverable requirements, identifying issues and implementing remediation plans. The risk management solution provides advanced capabilities such as risk calculators and risk assessment for risk analysis and monitoring. The ValGenesis system comes with best practice templates to define the scope of processes and sub-processes for risk management. It also guides the development of controls, remediation plans and test libraries.
Applying risk assessment procedures for validation is a highly effective means of ensuring that all the critical high risk requirement 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 or process. By adopting the risk assessment approach provided through ValGenesis gaps will be identified and validation or verification deliverables are defined.
- ValGenesis supports most of the commonly adopted risk management processes including FMEA. End users are able to mirror their current risk assessment procedures with no required customization.
- ValGenesis allows users to conduct risk assessment at the computer system, equipment, and 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 level. Based on the selected risk model ValGenesis will allow users to determine risk for each risk factor and the system will automatically calculate the risk score.
- 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
Delivering Risk-based Decisions
ValGenesis Risk Manager is an integrated part of the ValGenesis validation and application life cycle management software system, designed to help your organization drive a connected, value-enhancing approach to validation, change management as well as enterprise risk management.
Through this framework, organizations can:
- Create a connected view of validation, change and risk management.
- Make audits of the risk function easier and less time-consuming.
- Centralize and streamline your risk management program.
- Proactively manage all types of risk across your business with a single and secure web-based software tool and improve the effectiveness and efficiency of risk related processes.
- Integrate risk management into key processes including Validation and Change Management.
- Make fast, informed decisions to prevent and mitigate risks.
- Real-time dashboards and robust reporting capabilities provide access to your organization’s risk data at a glance and facilitate fast and effective allocation of resources for risk treatment.