21 CFR Part 11 Compliance

ValGenesis VLMS System Overview

ValGenesis is a web-based integrated Validation Lifecycle Management System (VLMS) that manages the entire validation lifecycle process. ValGenesis system starts with Validation Planning, Risk Assessment, Project Planning and Requirements Management and, then moves on to Test Case/Protocol Development, Dynamic Trace Matrix Generation, Electronic Execution and completion of the validation life cycle with the Decommission/Retirement process. In addition to the Validation Lifecycle Management process, and within the system as integrated processes, the ValGenesis system supports Application Lifecycle Management, Risk Management, Change Management, Document Management, Periodic Review and Electronic Logbook Management.

ValGenesis expedites the validation lifecycle process and eliminates inefficiencies that plague paper-based validation processes. The ValGenesis system provides complete visibility for GxP assets and processes with real time validation status, instant access to validation data and documents, improving efficiency and enhancing consistency throughout the validation lifecycle process. This results in a reduction of validation cycle time and validation costs by 50%. ValGenesis also supports multi-site deployment, which allows organizations to segregate users and site specific data in addition to enabling users from different sites and/or departments to collaborate and share validation data and documents. ValGenesis eliminates redundant validation tasks across the site and/or organization; ultimately standardizing, globalizing and harmonizing the validation process across an organization

The following diagram provides a high-level view of the system.