Page 4 - Roche RIM presentation

Planning for a successful E2E RIM transformation
Important lessons learned from our experience of RIM implementation
Lesson learned:
Effective integration testing requires proactive coordination with downstream & upstream system owners. Further operations support including how you will communicate about outages and problems is important.
Action:
Clearly identify all integration point IT and System owners; clearly communicate project schedule and identify all interdependencies. Ensure that time is allocated for end to end integration testing.
Lesson learned:
Implement strong governance and sponsorship to drive fast design decisions and resolve bottlenecks effective use of white hat sessions is a must.
Action:
Define streamlined processes, workflows and roles to fuel technology solutions to deliver expected operations benefits.
Lesson learned:
Immediate focus on master data management is critical path.
Action:
Confirm the architecture is well defined and understood: where data resides, which system is the source of truth, and how the data elements are changed and propagated through the systems.
Lesson learned:
Do not underestimate the importance of change management , especially proactive and enthusiastic communications.
Action:
Develop a strategy for Change Management and Communication early in the process. Support the messaging with dedicated business champions / change agents early, providing the key messaging for “what’s in it for me?”.
Lesson learned:
Clear migration strategy and effective planning and communication with affiliates is a must.
Action:
Assess and prioritize areas to deploy first for “quick wins” and to gain familiarity with the new system before a larger deployment.
Integration Testing
Change Management
Phased Deployment Approach
Focus on Process & Roles
Integration & MDM
Dedicated Business SMEs
Case Study: Eli Lilly
Strong core team driving initial configuration followed by broader CRP involvement is a proven practice.
Designate dedicated Business SMEs to provide input into business processes, vision, process optimization, training, and adoption.
Lesson learned:
Action:
Outcomes realized
• E2E RIM Release 1 successfully went live in 2018 with submissions, product and registration management capabilities enabled.
• Global alignment on key variation management processes (e.g. regulatory impact assessment, variation planning, commitment mgmt. and submission mgmt.).
• Innovative approaches to managing product data and submission documents to facilitate efficient and accurate product release.
• Development of CoE to support regulatory intelligence and correspondence and commitment management.
• A comprehensive 32-course curriculum, enabling the on-boarding of hundreds of global end users to RIM and driving adoption of a complex system and terminology.