Fremont, CA April 07, 2006,
ValGenesis Inc., the pioneer in validation automation, and compliance management software for the life science industries, announced today the addition of two innovative functions to the ValGenesis system, the Witness and Review functions. The new functions, designed to enhance document development and execution, compliment the existing framework by ensuring the removal of any inefficiencies or deficiencies inherent to paper based documents. With the inclusion of the new functions, the richness of the ValGenesis system ensures an application that closely matches well-established paper processes and enhances productivity.
Innovative functions to the ValGenesis system, the Witness and Review functions. The new functions, designed to enhance document development and execution, compliment the existing framework by ensuring the removal of any inefficiencies or deficiencies inherent to paper based documents. With the inclusion of the new functions, the richness of the ValGenesis system ensures an application that closely matches well-established paper processes and enhances productivity.
Until recently, to complete the validation process in the paper based system which includes protocol development, execution, incident management and the review of related activities, up to 70% of valuable human resources might be consumed, delaying revenue producing manufacturing activities. ValGenesis’s unique technology automates the corporate validation process and removes the potentially time consuming tasks and provides consistency and compliance in the corporate validation process.
ValGenesis added Witness and Review features to address the needs expressed by its clients, who envisioned the witness function as a tool that enhances compliance and further augments productivity. The Witness function gives users the ability to ‘witness’ during the validation execution and can be enforced based on qualification requirements. Because the witness functionality is built into the ValGenesis system, it closely follows a paper-based process and allows for a second user to sign off, verifying the expected execution. The ability to adapt the witness requirement is completely configurable by the ValGenesis system administrator at the protocol level and can be adapted for specific GxP entities and/or qualifications.
The Review function created for document development and execution provides the user the ability to route the document for review after the development and execution process. This feature allows selected reviewers access to the document simultaneously, permitting comments by all those involved. By routing the document for review in tandem, the length of time for review is reduced dramatically. Moreover, granting reviewers the ability to view all comments pertaining to the document allows true collaboration as well as increasing document quality. Once the review period has ended and each of the reviewers has confirmed review of the document, the developer is able to assess all comments making any required changes before routing the document for approval.
Quoting Siva Samy, President of the ValGenesis Company: "The validation process generally requires a time consuming manual process, it has been our goal to create a system that automates the corporate validation workflow and removes the inherent deficiencies associated with the current manual process". Dr. Samy further added: "Through these innovative new features, ValGenesis provides a holistic view of the validation status corporate wide and helps to uncover bottlenecks in the process. Clients have targeted the ValGenesis system as a means of reducing validation cycle times by at least 50%".
About ValGenesis
ValGenesis is an innovative software platform designed to provide the foundation for compliance-based validation activities in life science companies. ValGenesis’s unique technology removes the potentially time consuming tasks and provides consistency and compliance in the corporate validation process. ValGenesis is the first Enterprise application to automate the corporate validation life cycle and to track the Validation Inventory. Through an industry peer review committee, The Parenteral Drug Association (PDA) recognized ValGenesis by awarding it the very prestigious New Innovative Technology award for the year 2005. ValGenesis is designed to be fully compliant with US FDA 21 CFR Part 11 compliance requirements. For more information about ValGenesis, you may contact Emmanuel Cansino at 510.445.0505 or e-mail This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
