tackling the implementation challenges of...
TRANSCRIPT
Tackling the Implementation
Challenges of Serialization and
Track & Trace programme
exlPharma
May 9-10, 2013 Philadelphia
Presentation Topics
• Regulatory Status
• Why an End-to-End T&T approach ?
• Execution Framework – fokus on Change management and System Integration
• Achieving Benefits through T&T
• Key Learnings
• Q&A
Classification: xxxx Author xxxx Approved by xxxx Version xx 2
NNIT IT for life sciences
• NNIT was born as an internal IT department at Novo Nordisk in the pharmaceutical industry
• +2,000 employees and one of Europe's leading consultancies in life sciences IT
• Clients served in both Europe, US and Asia
• Life science IT is our core business with complete, practical experience with the entire pharmaceutical value chain
• We are the leading consulting and engineering company in the complex field of pharmaceutical and biotech industries
• We count app. 1,700 professionals with project experience and knowledge related to pharmaceutical and biotech industries
• More than 200 have hands-on
development or production experience
• We executed 2,667 projects in 2010
NNIT/NP – Global Delivery approx. 3.800 people at 40 locations
New Jersey (Princeton)
Phillipines (Manila)
China already live and products are rapidly being added to the EDL – by 2015 all products needs to be serialised
US/California Timeline stands at 2015/2016
Europe SecurPharm pilot in 2013, Delegated Acts early 2014, Comply by 2017
Time in running fast – You need to act now !
China already live and products are rapidly being added to the EDL – by 2015 all products needs to be serialised
US/California Timeline stands at 2015/2016
Europe SecurPharm pilot in 2013, Delegated Acts early 2014, Comply by 2017
Implementation typically takes longer than you initially expect. At least 12-16 months from start of planning.
Foresee serious bottlenecks in market for skilled resources / OEM vendors – likely to delay your project
Time in running fast – You need to act now !
Track and
Trace
Track and Trace impacts your business on multiple levels
Counterfeiting
Serialization
Brand and Customer Value Supply Chain Management
Business Intelligence
Track & Trace involves many stakeholders - think end-to-end and involve all early on
Track & Trace
Project
Sales & Mark
IT
Regu-latory
CMO’s
Production Logistic
Artwork
Legal / Costumer Complaint
QA
• Artwork Changes • Approvals
• IT Architecture • System Integrations • Master Data Mgmt • Security • External data exchange • Scalability
• Reg. Roadmap • Approvals
• CMO Readiness • Data Exchange • Artwork changes
• Line/Site Changes • Leverage prior invest • Warehouse Mgmt • Training
• SC Integration • Data Exchange • Distributor Readiness
• Risk • Contracts • RfP’s
• SOP Changes • Validation • Training
• Branding • Forecasting • New Markets
Serialisation/T&T programmes are large and complex
Business requirements
Project office
Program Mgt.
Progject Mgt.
Facility Mgt.
Project economy
OCM
Training coordination
Communica-tion
planning
Global communicat.
Training coordination
Solutions implementati
on
Technical experts
Functional experts
Integration and auth. execution
Systems validation
Validation planningb
Test execution
Validation reporting
Quality management
Solution quality
Process quality
Integration overview
Solution issues
Business requirement
s
BPR
Classification: xxxx Author xxxx Approved by xxxx Version xx 10
SAP PI
SAP AII
SAP ECC
Site Systems
Legacy
WMS
SAP OER
AL
BP
AL
BP
AL
AL
Integration governance Integration guidelines = Validated integration
BP BP
AL
PI Enables • Connection Logic and transformation logic is centralized in one system • Data is validated on both recieving and sending end • End-2-End Monitoring is handled via SAP PI PI is governed by • Clearly defined development processes and –guidelines • Clearly defined responsibilities during analysis, design, development and error handling • Validated integration
NNIT Validated Platform
BP AL
Intelligent Integration is key to compliance, robustness and low TCO
BP
Operational Framework for T&T Projects • Business strategy
• Vision overview
• Develop project charter
• Develop vision charter
• Change management strategy
• Stakeholder engagement
• Application design & implementation
• System integration & data migration
• Test and validation
• Infrastructure
• Org. Change management
• Processes and requirements
• Project management plan
• Key PM process
• Refine project charter
• Business, System & Data analysis
• Change management strategy
• Stakeholder Training
• Application design & implementation
• System integration & data migration
• Test and validation
• Infrastructure
• Org. Change management
• Advisory
• Future roadmap • Solution strategy
• KPI’s
• Application design & implementation
• System integration & data migration
• Test and validation
• Infrastructure
• Org. Change management
1 mth
3-4 mth
8-12 mth
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Insight into diversion
Minimizing Counterfeit
Impact
Efficient Chargebacks
Effective Recalls
Patient safety Transparency in the supply
chain
Enhancing brand value
Brand
protection
Tangible and intangible benefits
Efficient Clinical trials
Report Adverse
Events
Learnings and Best Practices Track & Trace
Best practices in Serialization Projects
Think end-to-end Involve all stakeholders early on
Think Total Cost of Ownership
Standardize where possible
Select an experienced Partner with global reach
Consolidate the no. of Suppliers
Take-Away Messages
• Get started now !, - Time is running out
Take-Away Messages
• Get started now !, - Time is running out
• Invest significant time in the Analysis Phase
Take-Away Messages
• Get started now !, - Time is running out
• Invest significant time in the Analysis Phase
• Think End-to-End and don’t cut corners ! Engage with an experienced partner.
Torben Vogt Life Science Industry Expert NNIT A/S Østmarken 3A DK – 2860 Søborg +45 44 42 42 42 (phone) +45 30 75 43 38 (mobile) [email protected] www.nnit.com
Your NNIT Contact
NNIT is one of Europe’s leading consultancies in the development, implementation, validation and operation of IT for the life sciences industry. We create value for our clients by treating their IT as if it were our own and, of course, we meet the industry’s strictest requirements for quality. For nearly two decades, we have applied the latest advances in technology to make our clients’ software, business processes
and communication more effective. NNIT employs 2,000+
people and in 2012, our turnover was €265 million.
Thank You !