ISPE/MESA Seminar Merck Sharp & Dohme Biologics Ireland Delivering value from MES: Optimizing Manufacturing Efficiency Paul Murray MES Manager Cordis

The following Strategic Initiatives of MESA International are associated with this presentation : Lean Manufacturing Quality & Regulatory Compliance Real-Time Enterprise

Agenda Introduction Manufacturing IS Strategy Business Drivers Business Process Mapping Interfaces & Information exchange Issues

Introduction Cordis (part of Johnson & Johnson) Medical Device - Cardiovascular Cashel Manufacturing facility (In start up) – Manufacture next generation of Drug Filled Stents – Full eBR in place at start up

Manufacturing IS Strategy No one size fits all strategy to define what level of automation or what level of information acquisition is appropriate. Highly diverse business processes with this industry –API –Secondary batch based manufacturing –Biotech –Medical Device discrete manufacturing But Convergence is happening! Technology and business drivers are not the same. Technically driven strategies tend to run into problems that do not always maximise the value of the technology. A strategy that takes a balanced view of all business drivers and is well aligned will generally be more successful and deliver greater value.

Business Drivers Operational business drivers –One, few or many products? –Fastest throughput, or maximised capacity? –Headcount – as driven by rest of design and philosophy? –Quality – by exception or checked/tested –Shop floor visibility, access to real time information –Lower Inventory Regulatory business drivers –Enforce greater compliance Project Business Drivers –Project execution intent – fast track, minimum cost, balanced?

What is a business process? A business process is the sequence of steps followed by various users in order to complete an end to end business operation There are many business processes required to allow a business to function

Gaps and Overlaps BPM will identify data collections inputs/outputs, decision points within the process By mapping our applications to the BPM we can identify integration points, gaps and overlaps When we understand the this we can develop an application and integration roadmap. We can also have an opportunity to lean out existing processes. Based on the this we can make decisions on application implementation ManugisticsERPMESLIMS

Clearly define the technology and interfaces Level 3 & 4 Global Application Instances Level 3 Plant Information Systems Level 2 Realtime Monitoring & Control Systems ERP Enterprise Resource Planning ERP Enterprise Resource Planning EDM Enterprise Document Management EDM Enterprise Document Management LMS Learning Management System LMS Learning Management System CAPA Deviation Management CAPA Deviation Management LIMS Laboratory Information Management LIMS Laboratory Information Management CMMS Computerized Maintenance Management CMMS Computerized Maintenance Management MES Weigh & Dispense Finite Capacity Scheduling Electronic Instructions/EBR Resource Tracking MES Weigh & Dispense Finite Capacity Scheduling Electronic Instructions/EBR Resource Tracking PIM Process Monitoring Process Modeling & Optimization PIM Process Monitoring Process Modeling & Optimization DCS & PCS Process Control Systems DCS & PCS Process Control Systems EMS & BMS Environment & Building Monitoring EMS & BMS Environment & Building Monitoring CDS Chromatographic Data Systems CDS Chromatographic Data Systems Data Historian Continuous and event data Data Historian Continuous and event data Lab Equipment Analysis systems Lab Equipment Analysis systems

Interface/Information exchange Clearly define data dependencies/what needs to be exchanged between systems. Keep it simple – complicated interfaces will be require more effort to support/maintain. Use permissive type data exchange. i.e. status flag good/not good to go. Only interface where it makes sense – where there is ROI

Focus on reuse and little customization Can core systems be used Common platform, interfaces to global systems (ERP) Standard business practices, minimize local customization Minimize local validation Can standard configuration objects be reused Same process, different products (e.g. tablet compression), different parameters. Minimize configuration and validation effort.

Issues/Risks Having an agreed Strategy is crucial Buy-in / commitment of all stakeholders essential – Systems have cross functional impact Invest thoroughly in the design to GET IT RIGHT FIRST TIME!…. SAVES MONEY!! Prototype to get stakeholder buy in and set expectations Risk-Based Approach to Validation Supply Vendors with standards / detailed information (e.g. specifics on data structuring, interfaces OPC, XML, etc)

People challenges vs technology challenges The way we have always done it is fine. ERP/MES enforces business process. Different departments/sites may/will have different views Traditional ‘business’ IT vs. ‘Manufacturing’ IT Fear of e – systems