the multi-site ram experience
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
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The Multi-Site RAM Experience
Norm RabinSenior Quality Manager, Calibration
Roche Diagnostics, Indianapolis
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Multi-site Advantages
• Significant Cost Savings/Cost avoidance• Improved compliance across sites• Easier Validation• Improved Reputation with Regulatory
Agencies
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Multi-Site Can Save This!
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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
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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
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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
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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”
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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.
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Drive for a Common Process
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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
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Teamwork and Division of Labor
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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
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EXAMPLE OF AN ASSET INDUCTION PROCESS FLOW DIAGRAM
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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!
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The Help May Be Different Than Planned