This presentation covers the issues around integration, the global preponderance of GS1-compliant markets and the up-coming US Food and Drug Administration regulations on Unique Device Identification.
13. Market Driven Labeling Nearly 70% of GPO’s Demanding GS1 Less than 50% of the Manufacturers Adopting GS1
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15. Barrier to GS1 Adoption Waterfall Hospital – Demanding Data Standards GPO – Carries Demands to Manufacturers Manufacturer – Lack the Resources to Implement Data Standards
16. Why GS1 Adoption is Important to You Recent conversation with a major medical device manufacturer: “It took us more than four years to adopt GS1 data standards.” Examples of GPOs Mandating GS1 by 2012! $780 Million Plexxus - Canada $73 Million under contract (device only) NHS PASA (UK) $670 Million under contract Sisters of Mercy ROi – US IDN $31 Billion under contract Novation – US GPO $30 Billion under contract Premier
17. Critical Pressures to Your Business Regulatory Market FDA Amendments Act of 2007 Unique Device Identification (UDI) Data Standards Adoption
Discovery Phase: Project Planning – A detailed understanding of timelines, scope and objectives, project phases and resources. Current State Assessment - A documented current state that should include: Inventory all processes, applications, tools and data Inventory of all business process flows Detailed review of all requirements Definition of the existing infrastructure (including all environments; DEV, TEST, PROD, FAILOVER) Outline of the number of environments that will be necessary The project team will develop a prioritized list of needs that identify how the requirements will be addressed; which requirements will be accomplished through Loftware, Customer, or a combination Approval to proceed with Analysis Phase Analysis Phase: Validation of business needs and proposed business flows Validation of proposed environments Validation of legacy systems details; data and integration points Proposal for promoting legacy system components to new solution Validation of implementation approach and refinement of project plan Project scope and plan finalized Approval to proceed with Design phase Design Phase: During Design we are building out the DEV environment Finalize the Solution Design Install and configure the Development environment Build the new Business Process Flows and Integration points between Loftware and Host System Design the appropriate Training Plan. This will include formal classroom training as well as over the shoulder knowledge transfer. Loftware’s training includes administration, operation and design training. Design the complete testing plan; integration, validation and end user training Design the promotion plan; a plan that identifies how to move configurations, integrations and designs from DEV to TEST to PROD Approval to proceed to the Delivery Phase Delivery Phase: We are delivering the approved DEV environment to TEST Delivery of a fully functioning TEST environment Execution of the training plan Performing Validation Testing according to the approved plan Providing Integration support Transition Phase: We are delivering the approved TEST environment to PROD/FAILOVER Validation of the Production and Failover environments Launching Phase 1 Formal close out of Phase 1 Transition of Phase 1 to Production Support teams (Loftware and Customer) Begin Phase 2 of the project if necessary