Forecasting the TCO of Serialization

Transcription

1 Forecasting the TCO of Serialization

2 Agenda Calculate your serialization costs by holistically examining all elements involved in your implementation strategy Consider certain key factors when anticipating implementation costs, including underlying dependencies, validation costs, and lower productivity levels during downtime Adjust your budget to accommodate changes in local and international traceability regulations

3 An Important Axiom Price = initial investment only Cost = complete investment over lifecycle

4 Considered Elements Initial Costs Plant hardware IT Hardware (plant, enterprise) Software licenses (line, plant, enterprise) Implementation services (line, plant, enterprise) SOPs new and updates (line, plant, enterprise) Documentation new and updates (line, plant, enterprise) Training (line, plant, enterprise) Validation (line, plant, enterprise) New printing costs (adjustments to fit new barcode) Trading partner agreement updates Product launch impacts Contractual updates Risk assessment updates (possible new categories) Disaster recovery plan updates and new requirements

5 Considered Elements Recurring Costs New support agreements Hardware Software Services Increased media and supplies cost Increased data creation Storage costs Bandwidth costs Increased trading partner data exchange volumes Bandwidth costs Increased reporting requirements Storage costs Increased operational processes Time impact on COGS

6 Considered Elements Incremental Costs New product New packaging formats New regulatory requirements Hardware changes/upgrades Software upgrades New trading partners New data exchange requirements New operational requirements Artwork changes and approvals Downtime/Supply chain disruption due to changes

7 Summary of Costs: Considered Elements Calculate your serialization costs by holistically examining all element involved in your implementation strategy. Packaging lines Line level Hardware Software SOPs Site level Systems Software Integration SOPs Enterprise level Systems Software Integration SOPs Trading partner integration Trading partner SOPs Documentation Validation Regulatory reporting Change management Support Training Downtime Product availability Printing space and brand management Artwork changes and approvals

8 Key Factors Every hardware component, software package, network connection, systems interface, integration service, supportive service, and operational service are simultaneously investment buckets and potential points of failure

9 Key Factors Production impact Time Cost Risk Supply chain impact Product availability Trading partner data exchange Trading partner(s) audits for compliance to regulations Supply & Demand Hardware availability Software availability if not GAMP Class 4 Professional services (limited serialization resources) Internal resources (competition with other projects)

10 Key Factors Line of business application support serialization s affects on Inventory control Master data Warehouse management Order management Reverse logistics Business Process Changes Order-to-cash process Supply chain network compliance Returns processing Customer support Data governance Regulatory Exception handling

11 Key Factors SOPs Line level processing for WIP materials Finished goods inventory processing Quality assurance Sampling Investigations Order fulfillment Data collection New product launch Master data management Validation Scope (top-floor to plant-floor integration) Forward looking where possible Regulation timeline in phases

12 Summary - Key Factors Consider certain key factors when anticipating implementation costs, including underlying dependencies, validation costs, and lower productivity levels during downtime Inventory control Master data Materials management Warehouse management Order management Supply chain management Customer support Returns processing Trading partner compliance New product launch Validation Quality assurance Data governance Data collection Exception handling Data exchange Regulatory reporting Systems integration Professional services Supportive services Internal resource conflicts Product availability Downtime

13 Change is inevitable Adjust your budget to accommodate changes in local and international traceability regulations

14 Change is inevitable USA Requirements will continue to phase in until at least 2023, longer if there are delays or alterations based on the pilots, public meetings, required evaluations, and of course the US Congress.

15 Change is inevitable Additional markets are implementing or considering implementing serialization mandates

16 Change is inevitable Globalization and consolidation of manufacturing increases the likelihood of additional markets being served and different regulations being met.

17 Change is inevitable Global Changes may require: New hardware additions (e.g. bundle aggregation) Software modifications, upgrades, or reconfiguration New data exchange formats or content Updates to regulatory reporting Validation Changes in SOPs Documentation and training

18 TCO - Summary Serialization is far reaching in its impact Most serialization pilots and early implementations have ignored business application impacts and integration requirements Supportive services and after go-live costs can far exceed the initial investment, but are rarely considered up-front The myriad of touchpoints included in all the parts needed to meet serialization compliance can be daunting, but it is critical to consider them and most importantly understand their impacts on other elements

19 TCO Questions?