ValGenesis is Providing Customers Measurable Results in 25 Days to Achieve 100% Paperless Validation ProcessRapid Implementation Leads to Faster Service & Quicker Return on Investment


Fremont, CA  November 25 ,2006,

ValGenesis Inc., the pioneer in validation automation, and compliance management software for the life science industries, announced today a unique and rapid implementation approach, which focuses on proven practices that are leveraging customer investments as well as delivering tangible results in as few as 25 days.

Until recently, to complete the validation process in the paper based paradigm, which includes protocol development, execution, incident management and 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, plus it removes potentially time-consuming tasks by providing consistency and compliance throughout the corporate validation process. Furnishing a holistic view of validation, ValGenesis uncovers bottlenecks in the validation process and reduces validation cycle times by at least 50% compared to current paper based processes.

Quoting Siva Samy, President of ValGenesis: "By combining pre-configured ValGenesis application software with templates and rapid implementation methodology, our clients are now able to implement ValGenesis within 25 days. Our rapid implementation methodology not only provides faster service but it also affords a quicker return on investment for our clients.”

With the rapid ValGenesis implementation strategy the following solutions are delivered:

1. Drill down Inventory Report Manager and Dashboard - ValGenesis allows for real-time, corporate wide validation status tracking for any GxP entity that is registered in the system.

2. Consistency throughout the Validation Life Cycle - ValGenesis is designed to enforce consistency in the corporate validation life cycle through the use of templates.

3. Controlled and Configurable Approval Workflows with Proxy Approval – ValGenesis provides configurable approval workflows for developed documents and execution packages with a proxy approval option. With the proxy approval option, the proxy approver is able to approve any document in the event that the principal approver is not able to complete the task within the specified time frame.

4. Bridges the Communication Gap – Engineers, Reviewers, and Approvers are alerted of any tasks through the corporate e-mail system resulting in a more efficient document workflow. Furthermore, each user involved in the validation lifecycle is able to view the document workflow and audit trail for the document under development or execution.

5.  Electronic Execution to enforce compliance and eliminate illegible data entries – ValGenesis is the first application available today that is capable of executing documents with an automatic deviation management workflow initiated for any exceptional condition or deviation witnessed during the execution. With electronic execution, 100% paperless validation is achieved while meeting compliance and regulatory demands.

6. Re-Qualification Scheduling with Alert Notification – ValGenesis manages complex re-qualification schedules and will automatically alert user groups of impending or delayed re-qualification tasks ensuring critical GxP entities are re-qualified on time.

7. Incident or Deviation Management - During the execution, the incident template appears once an incident occurs, at which time the executor provides the details, assigns a severity level to the occurrence and routes each incident to reviewers for review and approval; remedial action can then be taken if required. In addition to the rapid implementation approach designed by ValGenesis, the implementation makes paper procedures a thing of the past, leverages ROI and delivers tangible results in as few as 25 days. For further information, contact Emmanuel Cansino at 510-445-0505 or e-mail him at cansino@valgenesis.com. You can learn more about ValGenesis by visiting their web site at www.valgenesis.com

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 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.