The Multi-Site RAM Experience

1. The Multi-Site RAM Experience Norm Rabin Senior Quality Manager, Calibration Roche Diagnostics, Indianapolis

2. Multi-site Advantages • Significant Cost Savings/Cost avoidance • Improved compliance across sites • Easier Validation • Improved Reputation with Regulatory Agencies

3. Multi-Site Can Save This!

4. WHY UPGRADE TO RAM R3 • Add Similar • efficiency • Bar Code Search • Efficiency and accuracy • Batch Assign • efficiency • Improved Audit Trail graphics • Linked & Smart Fields • Auto populate • Loop and System Assets • Enhanced operations • Multiple Windows • efficiency • Notification System • Pick Lists • User Defined Forms • Improved Processes • Request Types • Improved Processes

5. Financial Gaines with RAM • Reduction in Operating Budget of ~23% • Facilitates review of intervals for similar instruments • Allows alignment of ranges and tolerances • Provides quick review of extra pint calibrations • Easily indicates inside vs. outside calibrations • Facilitates compliance investigations • Allows improvement plans to reduce OCR events

6. Cost Savings/Cost Avoidance • Multi-site License versus Single-site • One instance of the Software vs. several • One unified set of User and Functional Requirements • One comprehensive application validation vs. several • One configuration vs. several • One process vs. several • Maintenance fees less • User license fees about the same

7. Cost Savings/Cost Avoidance • Cost of Application • Cost of User and Functional Requirements Development • Cost of validation plan development • Cost of Test Script Development • Cost of IQ, OQ, and PQ development and execution • Cost of QA documentation package review • The executed OQ was in excess of 1000 pages • The Functional Specification was 217 pages 11”x17”

8. Multi-Site Points To Consider • Maximum savings can be realized with a common configuration • Affiliates must meet and drive to a common goal, this will take at least 1 week sequestered • Flow Diagram all processes from each site and look for commonality • Use Corporate Policy and Standards to drive a compliant and efficient process definition • Define the What and the How rules • Be Clear who is validating what! Document this.

9. Drive for a Common Process

10. Multi-Site Points To Consider • Define the functions and roles • Documentation, Asset Induction, and Change control • Calibration, work execution • Metrology or Quality review • Supervision • Preventive Maintenance • Validation

11. Teamwork and Division of Labor

12. Multi-Site Points To Consider • Define the RIGHTS for each Role • What actions will each role be allowed to execute in RAM? • The RIGHTS must match the established requirements document and the flow diagram of the processes—where are double checks needed, etc. • Try to mimic the current compliant process, avoid creating a totally new process

13. EXAMPLE OF AN ASSET INDUCTION PROCESS FLOW DIAGRAM

14. Multi-Site Points To Consider • All Stakeholders must be engaged! • Blue Mountain • Each Site (site reps must be empowered) • Quality Assurance • IT • Each site must have a Champion! • Communicate, communicate, communicate • Distance and lack of engagement is your enemy • Forget one of the above and major difficulties will be realized!

15. The Help May Be Different Than Planned