Page 5 - Roche RIM presentation

Output and value driven delivery
We simplify MVP data and process change based on end user value
Value driven by adoption of system*
"How can the new RIM system be used to address end user pain points?“
CHF 16M
CHF 14M
An output-driven E2E RIM implementation enables a value driven scope definition and therefore leads to maximized business value
100% value realization*
Value driven by business change*
"What needs to be changed to successfully introduce the new RIM system?"
CHF 10M
CHF 8M
CHF 7M
CHF 7M
CHF 6M
45%
55%
Reduce the stress / anxiety of Regulatory to find and use data
Enable an E2E view from research to the patient.
Empower strategic initiatives e.g. PHC
CHF 8M
System Data
People
* Source: E2E RIM business case (constructed with Deloitte support)
We advocate a hybrid agile approach
Process RIM value by capability
In a GxP environment, requirements for validation before use mean a pure Agile approach is of limited practicality. We recommend a hybrid approach that combines useful characteristics of Waterfall and Agile.
Iterative development cycles: (Sprints) with individual story design, build, and initial testing
End-to-end Testing & validation: Takes place after main sprints concluded
Specialized sprints to address errors
Pre-sprinting: Test OOTB solution and assess where customization is possible, define requirements, align on scope
Finalize testing, validation & deploy
Do
Collect requirements, and leverage sprints to drive out the functional requirements and design
Define the “MVP” and “working product” to be delivered after each sprint as logical progressions of capability
Stick to Agile ceremonies (Stand-up, Sprint planning, Review, Retrospective)
End to
Don’t
We manage validation through a risk based approach
Deloitte takes a pragmatic, risk-based approach to validation that allows us to scale the amount of testing we do to help Roche meet regulatory requirements while minimizing the disruption to the implementation.
Start with a requirements gathering process before users know system’s functionality and customization options
Expect the product of each sprint to be a validated iteration of the system Abandon detailed planning of project phases and milestones
System Core Application Layer
Roche configuration
Validation summary report
System release memo
Validation plan
Validation summary report
Validation plan
Business req document
Install’n& operational qualification
System administration maintenance
URS,
Functional specs Technical specs
Operational and performance qualification
Baseline code (core app)
Change control (core app only)
References to pre-validated core layer
Deloitte’s strong relationship with system vendors allows us to work closely with them during the implementation to leverage the validation they conduct on their core technology platforms and focus validation effort on configured functionality.
Roche-specific configurations and integrations