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

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

Multi-Site Can Save This!

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

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

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

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”

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.

Drive for a Common Process

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

Teamwork and Division of Labor

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

EXAMPLE OF AN ASSET INDUCTION PROCESS FLOW DIAGRAM

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!

The Help May Be Different Than Planned