ValGenesis
Dynamic Lifecycle Management Strategies

Application variations are inevitable and unavoidable for global companies in order to meet continuous changes in development processes and user requirements. Since the requirements, design specifications, and test cases of the applications are all related, any change to one specific requirement will impact the rest as well. Each change requires impact assessment and a plan to mitigate the impact. It also requires a significant effort to control all the artifacts and processes associated with the change. ValGenesis ALM’s (Application Lifecycle Management) closed loop change management approach helps to track changes more closely with much tighter emphasis on the risk associated with the change request. “Based on the risk level, priority, and severity, we focus on the process flow to be adopted, impacts of the change on related items, and the stake holders and responsible users for managing the change control process,” says Siva Samy, CEO and Chief Product Strategist, ValGenesis.

Fremont, CA based ValGenesis provides robust ALM solutions designed specifically to validate and maintain the validated status of complex software applications—GAMP 5, Category 4 and 5. The company’s ALM also eliminates the inefficiencies inherent to managing the validated status of enterprise software applications and dynamically summarizes all the impacted requirements, design specifications and test cases into a single change control validation summary. The approved validation documents of the ALM generated through an automated validation process are stored in the Library module in ValGenesis or can be pushed into corporate document management systems with all the necessary security to ensure the integrity of the documents. “Our ALM solutions provide 360 degree visibility for the validated GxP software systems across various sites,” says Samy.

In one instance, Varian Medical Systems was seeking a software solution that could maintain the validation status of GAMP 5 Category 4 and 5 software systems, such as the SAP enterprise software system. ValGenesis was selected for its validation-centric ALM function, which enabled users to manage individual requirements and then dynamically created executable summary documents by consolidating all the impacted items from a range of requirements and test plan documents. “We wanted to improve upon the laborious manual processes involved in the ongoing maintenance of validation status,” says Larry Lindberg, Manager of IT Validation, Planning, Procurement, Security and Data Privacy, Varian Medical Systems.

We want to help global companies in managing their validation processes electronically and our solution is ideal for those requiring consistency

“ValGenesis provided the kind of collaborative partnership we were hoping for as we worked together to configure the system.”

Apart from its validation-centric ALM functions, ValGenesis also provides efficient risk assessment strategies. ValGenesis’ risk management solution offers advanced capabilities such as risk calculators and risk heat maps for risk analysis at the requirement or functional level. The ValGenesis system comes with best practices templates to define the scope of processes and sub-processes for risk management. ValGenesis Risk Manager is an integrated part of the ValGenesis validation and application lifecycle management software system, designed to help the organization to drive a connected, value-enhancing approach to validation, change management, and enterprise risk management as well.

Forging ahead, ValGenesis will continue to manage the corporate validation process of its ALM solutions to enforce consistency, enhance compliance and standardize the corporate validation process. The company’s mission is to provide state-of-the-art enterprise software applications that better manage and automate its existing solutions, improve quality, and streamline operations of ALM. “We want to help global companies in managing their validation processes electronically and our solution is ideal for those requiring consistency across all areas that need to be validated,” concludes Samy.