How to Use Reporting & Analytics in Agile PLM to Drive Added Value

1. How to Use Reporting & Analytics in Agile PLM to Drive Added Value August 23rd , 2018 Prepared by: Arun Sharma @NexinfoSolution

2. Who Is NexInfo? SUMMARY • Consulting company focused on helping clients achieve Operational Excellence via an optimal blend of Business Process & Software consulting services • Deep domain expertise, including: Integrated Business Planning, Sales & Operations Planning, Supply Chain, Product Lifecycle Management, Predictive Data Analytics, Security & Compliance, and Business Transformations • Founded in 1999 and managed by computer industry & business process professionals • Clients include emerging companies and Fortune 1000 corporations • Recognized in the industry, including features in Gartner Reports, The Silicon Review (50 Smartest Companies of the Year 2016 and 10 Fastest Growing Oracle Solution Providers 2017), and CIO Review (100 Most Promising Oracle Solution Providers 2015) PARTNERS CORPORATE INFO • HQ in Orange County, CA with offices in Redmond, WA, Chicago, IL, Bridgewater, NJ, Dublin, Ireland, Chennai & Bangalore, India • Operations across the United States, Europe (Ireland, UK, Switzerland, Belgium) & India

3. Presenter Information Name: Arun Sharma Experience: Arun Sharma is a Product Innovation leader with expertise in Product Management and User Experience. His deep domain expertise in the High Technology Industry combined with innovative experience in the Life Sciences & Pharmaceuticals industry provides clients with solutions that provide a high quality user experience and enhances business value. With over 18+ years of industry experience, Arun Sharma engages with client on Solution Development, Business Process Reengineering, Business Strategy and IT Program Management.

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5. PLM Journey

6. Key Challenges for New Product Introductions • Which products have the most changes in pilot / product ramp phases? • What is the Mean Time Between Design Failures & Change per Product Line? • How we do improve the engineering change cycle time metrics? • How many new parts have been introduced into our new products? • How many parts in the new products lack price, compliance data? • How many single-source parts have been designed into each new product? • Who are the most leveraged manufacturers in current products? • How will the Top-50 Manufacturers change with our new product introductions? • Do any of the top Manufacturers have Quality issues? Are any due for an audit? • Who are the high risk manufacturers in our new products? • What is the level of part obsolescence risk? • How do we manage these manufacturer and/or supply risks?

7. Agenda Oracle Product Life Cycle Brief Oracle Agile PLM Out-of-box Dashboard & Reporting Capabilities Oracle Product Lifecycle Analytics

8. PLM Overview

9. What is PLM ? Purpose of PLM Program & Project Management Structured Electronic Drug Development Record (eDDR) Integrated Supply Chain Management Technology Transfer & Collaboration Integrated Quality Management Drug Development Portfolio Management Building Blocks of PLM in Industry Specification Management Formula / Recipe Management Global Product Registration Comprehensive Packaging & Collateral Management One Source of Truth for Product Data Platform for Collaboration (Internal & External) Close Loop Process for Change Management Reduced Time to Market Collaboration, including Vendor Management Product Change Management Processes & Workflows Enterprise Systems Integration Dashboard & Reporting Pharma specific functionalities General PLM capabilities applicable to Pharma industry too PLM capabilities cutting across product development process Legend:

10. Agile Product Portfolio Management Agile Engineering Collaboration Executives & Program Office Development & Engineering Agile Product Governance & Compliance Compliance Office Integrated product, program, resource & portfolio management Engineering desktop integration & collaboration Product & program compliance against standards & regulatory requirements Agile Enterprise Visualization Cross-Enterprise Quality Professionals Native document collaborative visualization across the global enterprise Agile Quality Management Agile Product Collaboration Operations & Supply Chain Closed-loop product quality management across the extended enterprise Agile Product Cost Management Procurement Professionals Enterprise product record visibility, management & collaboration Strategic sourcing and lifecycle cost & risk management Oracle Agile PLM Module

11. Oracle Agile PLM Capabilities • R&D (NPD) Data • Design Experiments • Formulas, Recipes, Processes • Materials, Equipments • QbD Attributes • Lab/ELN Data, Clinical Results • Program-/Project Data • Project Plans/-Templates • Schedules, Resources • Constraints, Risk • Audit Management • Marketing / Launch • Launch Plans, Datesper Region / Country • Mktg Collaterals • Briefings • Sales Tools Product Lifecycle Management • Quality & Compliance Mgmt. Data • Adverse Events /CAPA • Quality Attributes • Quality Planning • Audit Management • Pack/Label Quality • Product Risk Management • Suppliers Data • Approved Suppliers/Vendors • Quality, Availability • Material Dispensing, DeliverySite requirements, Lot Mgmt. • Packaging / Labeling Data • Packaging BOM / Artworks • Collateral / Text Libraries • Pack Specs linked to Regulations & Standards • Manufacturing Data • Tech Transfer Data • Sites, Plants • Bills of Materials, • Bills of Processes • MBR, Specifications • Mfg. Instructions/SOPs • Revision data • Change Management Data • Change Requests (R&D, Clin; Mfg; Pack/Label, Regulatory) Deviations • Collaboration, Workflows, e-Signatures • Change History, Change Documentation • Regulatory Submission Data • All Regulatory Assurance Docs • Dossiers PIM/SPL, Revisions

12. PLM Dashboard, reporting capabilities

13. PLM Dashboard & Reporting Within the context of a Lifecycle Management solution, reporting refers specifically to the availability of intelligence and information while managing various aspects of product development. Features • Define the appropriate metrics based on business objectives and organizational strategy • Establish one common, fully automated system for dashboards and reports • Enable real-time visibility to people, products and process status • Data aggregation capabilities bring together multiple data sources • Integrate with other systems in the enterprise • Triggers for slippages across the extended enterprise Potential Benefits • Real time visibility to people, product & process status • Enhance team productivity • Reduce guesswork and make better decisions • Increase first time success rate

14. Agile PLM - Type of Reports

15. StandardReports Process Reports Contains reports for changes and transfer orders. Contains all administrator user reports. Contains the standard Product Collaboration (PC) reports Contains the standard Product Cost Management (PCM) reports. Product Reports Sourcing Reports Administrative Reports Contains the standard Product Quality Management (PQM) reports. Contains the standard Product Governance & Compliance (PG&C) reports. Contains standard reports for Product Portfolio Management (PPM) solutions. Sub folders include End User Reports, Portfolio Reports, Program Reports, and Resource Pool Reports. Program & Portfolio Reports Compliance Reports Quality Reports

16. Product Reports

17. Process Reports

18. Admin Reports

19. AgilePLM – TypeofSearches Parametric Search Relationship searches for any class that has a Relationships tab Four Types of Where-Used Searches available in Agile PLM Where-Used Relationship Quick/Advanced Search Raw Materials with missing Manufacturer Name/Number/Description/Lifecycle Agile PLM – Audit Trail Capabilities • Agile PLM maintains the complete audit trail for the released objects. • For non change-controlled attributes, the audit trail for released objects is captured on the object itself.

20. Just a collection of reports enough to make real-time decision? Performance enhancement and achieved Operational Excellence

21. Oracle Product Lifecycle Analytics Need comprehensive application to manage Profitable Product Innovation

22. What is the OPLA Integrates Data for Analysis and Reporting Prebuilt integration of data from Agile PLM and a Configurator to map Agile PLM customizations to the PLM data warehouse optimized for analysis Provides User-Friendly Analytic Model of Enterprise Information and Metrics • Embedded PLM best practice calculations, metrics, and KPIs • Easy for business people to configure, access, analyze, and use the information Delivers Personalized Performance Dashboards for Everyone • Hundreds of prebuilt reports with role-based dashboards for key new product development and product launch organizations 3 PLM DW Agile 9 PLM

23. OPLA Architecture

24. DASHBOARDS & REPORTS • Prebuilt best practice library • Guided Navigation • Actionable Insights • SUBJECT AREAS & Configurator • Best practice subject based models & metrics for PLM processes • Business Analyst capabilities to configure PLM process & business unit specific metrics • Pre-built ETL , Metadata, Multi-Dimensional & OLAP Model • Configurator to map Agile PLM customizations

25. GuidedNavigation& Insights to Action Multi drill-analysis Ad-Hoc analysis Prioritize and execute on key decisions with product line operational managers Gain Insights Business Objectives / Issues Take Action

26. Role-based Dashboards • Change Orders • Manufacturer Orders • Engineering Stop Ships • Stop Ships • Item-Changes • Item-AML • Item • Manufacturer Parts • Product Performance

27. Role-based Dashboards

28. Functional Dashboards Customer Complaints Non-Conformance Report Corrective and Preventive Action Audit Item-Quality

29. Sample OPLA Dashboard Executive Scorecard Tab Provides quick status on key Agile processes, trends and distribution of Supplier NCR defects Product Events and Quality issues. Products Tab Provides snapshot status on New Product Proposals (“mini” version of PPM) Supplier Quality Tab Provides a trend and cycle time analyses on NCR Enterprise Audit Tab Provides insight on product lines that may have a high percentage of supplier defects or customer complaints and abandoned changes. Enterprise Efficiency Tab Measures efficiency of routing managers processing changes. ECO Cycle Time Tab Provides visibility to release cycle time for completed and open ECO changes to spot bottleneck PE Cycle Time Tab Provides visibility on release cycle time for processing Product Event defects

30. Oracle Product Lifecycle Analytics –Value Proposition

31. Take Aways

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