1. ValGenesis Closed Loop Change Management ValGenesis, Inc. 42840 Christy Street, Fremont, CA 94538 Ph: 510-445-0505 www.valgenesis.com

2. ValGenesis, Inc. – The Company PDA New Innovative Technology Award for being a first innovative software platform for electronic Validation Awards Through our Global Partner Network, ValGenesis can be implemented and supported globally Partners Global Life Science companies including Bayer, Roche, Novartis, Gilead, Noven, Hologic etc. Clients Regulated Life Science manufacturing companies Industries Over 100 years of combined industry experience in Validation, QA, and Manufacturing in Pharmaceuticals, Biotech and Medical devices industries Team Become the Standard Software Platform for Validation Lifecycle Management and Automation, and Electronic Log Management for Life Sciences Industries Vision

3. What is Change Control? A formal process used to ensure that changes made to a computer system, equipment, or product are introduced in a controlled and coordinated manner. Process includes initiating a change request, assessing the change and its impact on other systems, equipment, or products, approving the change for implementation, implementing the change, and approving the change once all required documentation has been completed. Overall goal of change control is ensure that each change has been thoroughly analyzed and assessed and that an implementation strategy has been designed, executed, approved, and documented. In the life science regulated environment, change control and change management is MANDATORY

4. Importance of Change Control In regulated life science industries, change control isn’t a luxury, it’s a NECESSITY! Meeting change control quality and compliance objectives is dependent upon your ability to: Implement a change control process with controlled workflows Share knowledge across business units and stakeholders. Track changes in real time from initiation to closure

5. Key Challenges with Paper Based Change Control Not all changes are logged correctly. Changes are not thoroughly analyzed with the appropriate before they are submitted through the change control process 1 Lack of communication between the various users affected by the change. Not all stakeholders are aware of the change. 2 Change control approval policies are difficult to enforce in a paper based process. Ensuring change controls are documented correctly is a problem. 3 Frequent changes to changes due to poor planning and lack of stakeholder involvement. Getting the right people involved from the beginning. 4 Change control is viewed as a burden that hampers productivity. A paper based change control process can negatively impact production activities. 5 Change control and validation are viewed as different activities. There is no system that combines change control and validation. 6

6. Benefits of ValGenesis Change Control

7. Controlled Change Control Workflows in ValGenesis Record Change Control Assess Change and Define Validation Requirements Pre- implementation Approval Implement Change and Complete Validation Post Implementation Approval and Closure Change Control follows a structured methodology and ValGenesis will manage the process from initiation to closure

8. Types of Changes Supported In ValGenesis Any type of change can be managed through ValGenesis Different changes can be classified in the system through user defined change types Change types are designed by the end user and allow different information to be captured for different kinds of changes

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10. User Defined Change Control Process Maps System allows you to define your change process including -determining the number of stakeholders required -Information to be captured and the field types -approval workflow for both pre and post implementation approval.

11. Initiating a Change Control Describe Change Justify Change Classify Change Select Entities (computer systems, equipment, processes) to be included in the Change. One or more than one entity can be included.

12. Change Review Board Assessment System allows change review board to assess the change to determine if the change can be implemented. If the change is unacceptable, it is returned to the change applicant If the change is accepted, the change review board will select the controlled change control process map for routing the change for assessment.

13. Stakeholder Assessment Stakeholders define the validation requirements for the change Stakeholders are required to complete all mandatory fields as defined by the selected process map

14. Transparent Process Flow System provides a graphical view of the change control process. Each user involved in the process is displayed within the process flow chart.

15. Audit Trails Comprehensive Audit Trails allow users to view the genealogy of any change with user ID and date and time stamp captured for each activity.

16. Change Control Reporting System provides easy access to view all changes by status. Click on the CCR No. to view the change control details.

17. Linking Changes to Validation System automatically displays all of the validation documents that have been generated as a result of the change control providing a truly closed loop change control process

18. Inventory of Entities and Change Control All Change Controls are displayed for each Entity All Validation Documents are displayed for each Entity

19. T Ph: 510 445 0505 Email: info@valgenesis.cominfo@valgenesis.com www.valgenesis.com hankYou Thank You