Risk Based Validation

Complex GAMP 5 Category 4 and 5 enterprise business applications – such as SAP systems – require code changes or updates for changes in business or user requirements. When a particular change is made to an application system or its supporting hardware components, management must ensure that it will not have any unforeseen negative impact on certain functionalities or data. Performing extensive validation, regression testing and documentation for the entire system every time a change is made – to ensure that everything works as expected – can be expensive and not sustainable in the long term. Risk assessment processes suggested by IT Infrastructure Library (ITIL) and Good Automated Manufacturing Practices (GAMP) will help organizations reduce the documentation burden by simplifying the degree of system life cycle controls relative to perceived risks.

The ValGenesis risk management solution provides advanced capabilities such as risk calculators, risk heat maps for risk analysis and assessing risk at the requirement or functional level. The ValGenesis system comes with best practices templates to define the scope of the processes and sub-processes for risk management. ValGenesis Risk Manager is an integrated function of the ValGenesis Validation and Application life cycle management software platform. It is designed to help regulate life science organizations to drive a connected efficient approach to validation and change management as well as enterprise risk management processes.

• Creates a connected view of validation, change and risk management. Eliminates the need of using disparate systems for each process, which leads into islands of data.
• 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 customization required.
• 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 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 allows users to determine the risk level for each risk factor (for example: Severity, Probability and Detectability) at the requirement or functional level 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.