ValGenesis is an Enterprise Validation Management and Tracking system. It is the first product in the industry to automate the corporate validation process and allows for a 100% paperless validation process. The ValGenesis solution focuses on automating the corporate validation process to assist firms operating in the FDA regulated space. The system is designed to manage the entire validation life cycle from validation document number generation to online execution and revalidation schedulingValGenesis enhances quality, improves efficiency, boosts employee productivity, and reduces operating costs.

ValGenesis is a modular, configurable, web based database application that is fully compliant with 21 CFR Part 11. Each module in ValGenesis serves a specific function such as tracking validation status, developing validation documents in a collaborative manner, executing validation documents, and scheduling revalidation tasks. ValGenesis maintains a consistent validation methodology across all departments and company sites. Configuring the system can be accomplished without and special programming skills.

This configurable design meanthat your Ready For Service time is reduced and you can begin experincing your Return On Investment almost immediately. ValGenesis meets the regulatory requirements outlined in 21 CFR Part 11 for electronic signatures and electronic records.

ValGenesis eliminates the amount of time that is otherwise spent searching documents manually. With ValGenesis, a validation document can be stored and retrieved in real time. Furthermore, ValGenesis is equipped with the unique ability to allow you to attain the validation status of any entity through three components:the Inventory Report Manager, the Drill Down Dashboard, and Barcode Scanning.

For the most part, a team of individuals working together will produce better results than an individual working in isolation. In recognition of this, ValGenesis was designed to allow validation test scripts to be developed in a truly collaborative manner by a group of users enhancing the quality of the validation document produced. The test script developer module manages the entire document development process from validation document number generation to document approval.

ValGenesis automatically creates unique validation document numbers for every document and test script developed within the system.

During the development of the validation document, ValGenesis enforces document consistency through the use of configurable templates. Once the validation engineer has completed developing the validation document, the document is routed through the configurable approval workflow.

With ValGenesis, the approval workflow can be configured for each document development task. The number of approvers and the order in which the document will traverse the approval workflow can be configured.

ValGenesis is the first product in the market that is capable of allowing you to conduct validation execution tasks online to achieve a 100% paper less validation process. ValGenesis does not mandate executing documents online and is equipped with a manual execution option. The online and manual execution options built into ValGenesis gives our clients tremendous flexibility in deciding how to execute documents.

ValGenesis manages complex revalidation schedules to ensure that critical GxP entities are revalidated on time. When creating a revalidation schedule, selected groups of users can be alerted of any impending or delayed revalidation tasks through e-mail or through the ValGenesis task alert feature.