In the current paper-based validation process, tracking the validation status of any system, piece of equipment, or instrument, is time-consuming and often submerged in a sea of paper. Overall, validation managers and supervisors spend an inordinate amount of time, searching out both validation status and documents, during the process. ValGenesis is designed to provide real-time, corporate-wide validation status in just a few mouse clicks, providing a holistic view of a company’s validation status and easily identifying bottlenecks, which expedites the validation process. To ensure its efficiency, ValGenesis offers three intuitive ways of tracking the real time validation status of any entity (system, instrument, equipment etc.) corporate-wide.

Real-time Validation Status through Inventory Report Manager

ValGenesis is designed with a drill-down Inventory Report Manager that allows tracking of the validation status of any entity that is registered in the system. The Inventory Report Manager stores entities in a user-friendly tree-hierarchy, for simplified navigation. Similar entities can be grouped into sub-categories, while comparable sub-categories can then be grouped under a category. ValGenesis does not restrict the number of categories, sub-categories, or entities that can be created. The taxonomy can be created based on client-specific requirements.

The Inventory Report Manager saves a significant amount of time that would otherwise be spent tracking the validation status of an entity. In ValGenesis, an entity can be located in just three mouse clicks, with complete details outlining the validation status of the entity, with the complete audit trail for each associated activity, including development, execution review, approval, etc.

Find Document Status in Real-time through Dashboard

ValGenesis also provides a dashboard that furnishes instant access to the validation status of any validation document currently in development. It also provides a dashboard of the execution phase of the validation life cycle, including documents awaiting assignment, under process, or pending approval. Upon logging into ValGenesis, users with the appropriate role can view the validation document status in real time, through a pie chart available in the dashboard. The dashboard feature is designed with pie charts, each subdivided into sections that provide a more granular look at either the development, or execution stages.

The drill-down dashboard provides a complete audit trail, with each activity captured during review and approval workflows, user ID and date and time stamps are included. This provides a valuable decision-support tool for allocating human resources, maximizing validation team efforts and locating the cause of any delay.

Find Real Validation Status through Barcode in Production Floor

Another important tracking feature built into ValGenesis is the barcode functionality. This allows the generation of unique bar codes for each entity registered in the system. When scanning the barcode associated with an entity, on the production floor, users can determine the real time validation status during an audit. This significantly reduces the time currently spent on retrieving documents from a document repository and provides the assurance of withstanding scrutiny by any internal, FDA or other external audit. In short, a tremendous amount of time is saved through the bar code feature, as it allows access to entity-specific validation information in real-time, on the production floor.

Validation Metrics

Any type of validation task, or process, needs a tool to ensure that goals and objectives are being achieved. Since the current validation process is predominantly manual, or a hybrid of manual and electronic systems, it is difficult to determine the metrics of the validation process.

ValGenesis converts the entire validation process into a completely electronic environment, capturing the task status and effort spent on each validation task, with user details, in real-time. In addition, to complete the validation process, the metrics functionality in ValGenesis provides the option to capture budgeted hours for systems, or projects. ValGenesis provides the following metrics through the dashboard and ad-hoc reports:

• Actual cost to validate each system and/or projects, against budgeted cost and time.
• Actual validation cycle time spent validating a system and/or project, against the planned duration.
• Performance of individual users, in terms of completing the development, execution, review and approval tasks, on time, vs. delays.
• Provides the details of the workload of individual users, which leverage available resources for new task assignments.
• Gains greater predictability over process inputs & outputs.
• Helps support data-driven decision-making based on fact, rather than feeling.