Enabling Digital Transformation in Life Sciences Industry

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Agenda

Present LandscapeAbout NewgenNewgens SolutionDigital Transformation ExampleQuality and Mfg ProcessDigital Transformation Advantages

CEO Top Priority Source: PWC 2015

Growing ChallengesHighly Document IntensiveEver Changing Regulatory CompliancesVisibility across all ProcessesScaling process and operationsMonitoring Productivity, SLA, TATsChange & Transition management

The average organization spends:$20 to file each document$120 to find each misfiled document500 hours a year looking for documents25 hours re-creating each lost documentLoses 1 out of every 20 documents

GARTNER

Newgen Overview1200+ Customers1 of 3 vendors to feature in MQs for iBPMS, ECM & CCM58Countries200+ Partners1600+ Employees100+ Healthcare Customers globally40+PatentsWorlds largest ECM Project in Insurance Sector with 9 Billion docs ECM MQ Visionary Quadrant

Investors

OfficesSingaporeUSA Florida Washington DCCanadaUKUAEIndiaNew DelhiMumbaiChennai

5Industry Recognized Product Portfolio

Global Presence: Marquee Customers BFSI FinanceBPO & Shared ServicesHealth Care & Life Sciences

Newgen Product Portfolio

Product Logical ArchitectureStraight ThroughProcessHeads Down ProductionProcessCollaborative HumanProcessSemi StructuredProcessFully UnstructuredProcess

Gateways Web Services JMS Web APIs UI Integration Advanced Terminal EmulatorIntegrationAdaptors

iBPMS ComponentsProcess InitiationFaxEvent

Scan

Mobile

EmailPortal

Process ExecutionEngine

Business ActivityMonitoring

Social MediaIntegration

Process Modeler

Content Management

ProcessSimulator

Mobile

IntegrationAdaptor

Business RulesManagement System

CEP

Analytics

9Newgen Solution iBPM ECM Process Accelerators

Content CaptureAppeals & GrievancesQuality & Manufacturing ProcessEmployee On-BoardingArt Work ManagementProvider ContractingPatient Record MgmtInfrastructureDatabaseServersConnectivity

Procure To PayRecord To ReportF&A Processes

Legacy Applications

Pharma: Solution AcceleratorsGoods Manufacturing Process

Document Lifecycle ManagementStandard Operating Procedure (SOP)Master Formula Record (MFR)Master Packaging Record (MPR)Batch Manufacturing Record (BMR)Batch Packaging Record (BPR)Batch Production Process

Artwork Management Process

Promotional Material Process

Close Loop Marketing

Healthcare Payer: Solution AcceleratorsMember Enrollment

Provider Contracting

Appeals & Grievances

Claims Management

Solution Accelerators for Hospitals

Document Lifecycle ManagementLegal Contracting and MaintenanceF&A Documents ManagementElectronics Customer Health RecordsCentral SOP RepositoryRecords ManagementDocument Acquisition ManagementPatient Record Management

Electronic Medical Record

Complaints Management

Consent Management

Customer Communication Management

Finance and AccountsTransactionalAccounts Payable (AP) or Procure-To-Pay (PTP)Accounts Receivable (AR) or Sales-Order-To-Cash (SOTC)PO ApprovalOrder to CashCollectionsGeneral Ledger (GL) or Records-To-Reports (RTR)Fixed Assets Management (FA) or CAPEX ManagementTender Processing / Quotation ManagementFreight Bill Processing Inward & OutwardMaster Data ManagementVendor MasterPrice MasterItem MasterVendor/Consultant AgreementsLease & AgreementsQuery ResolutionVendor Query ManagementHuman ResourcesEmployee ReimbursementsTravel & ExpenseMedical ClaimsPL EncashmentAdvance RequestPayroll Additions/ DeductionsLeave ManagementContract ManagementHire-to-RetireIndentOn boardingOngoing AppraisalsExit Formalities

AdminService Request ProcessTravel desk ManagementSuggestion Scheme ProcessSSC: Process Accelerators

Quality & Manufacturing Solution for Pharmaceuticals

15Cost of GMP* Non-Compliance* GMP refers to Good Manufacturing Practices Source: 1. BioPharm International, After the Consent Decree An Uphill Battle for Affected Companies, 1 Jun 2004, http://www.biopharminternational.com/biopharm/article/articleDetail.jsp?id=1022802. 2011, Daratech, Inc, Cambridge, MA, USA Reference. 8.178 (charts-ecmppv-pie-1.gif)$1,000,000Production Interruptions Cost per day due to halted productionConsent Decree Fines for failing to comply with GMP or other federal requirements

$50-500 mn$5 to $975KLegal Finesfor violations of environmental regulations by manufacturing facilities16GMP Compliance - Challenges and Risks

Newgen Quality & Manufacturing Solution for Pharmaceuticals

Newgen Solution Features

Document Lifecycle ManagementDocument AuthoringDocument ReviewDocument ApprovalQuality CheckEffective and Revised VersionsControlled DocumentUsageAutomated workflow for online document review-approvalFlexible workflow definitionSystem managed document statesDraft, In Review, At Approval, QA Pending Release, Effective, SupersededAutomatic PDF rendering & watermarking of documentAutomatic document version managementControlled document access & printingConfigurable document related states, types and metadataHOD Initiates Document CreationHOD Initiates document creationCaptures document details (metadata)Select workflow for review approval of draft document

Author Checks Out Document TemplateAuthorChecks out document template for creating draftChecks in, e-signs and submits draft document for review

21 CFR Part 11 Compliant

Solution satisfies CFR 21 part 11 requirements for e-signaturesDocuments e-signed using unique combination of username and password at each stage of document creation/revision lifecycleSignatures appended to document contain:Name of signerData and time of executing signatureReason for executing signature

21 CFR Part 11 Compliant

Signatures appended to document containName of signerReason for executing signatureData and time of executing signature

Reviewer Approver Annotates Document Rendition

Reviewer/ApproverReview draft document renditionSpecify review comments using annotations Send document back to author/ send forward for Approval & QA check

Two Document View

Reviewer can view previously annotated document and newly corrected document sent by author side by side

Quality Assurance User Sets Effective Date

Quality Assurance UserPerform final check of document renditionSpecify review comments using annotations Send document back to approver/ set effective date for document

View List of Recently Effective Documents

Strong Checkpoints for Batch Production

Process Order received

Automatic check for availability of correct batch production documents

Production documents attached for batch production

Documents watermarked and batch number recorded on Documents

Document Issued to Production for printing and usage

Documents Scanned and archived in system after production completion

Ensure right document delivery at drug production checkpoints

System Controlled Document Delivery for Batch Production

Batch number attached to document issued to production user

Compliance Desktop for Document Access

Instant online document access using Full Text Search and Advanced meta data searchControlled access and printing of documentsQuick access to document audit details for compliance audits

Access Document Audit Trails

System maintained audit trails about all document related user actions including:AuthoringCheck-out/Check-inRejectionReview, ApprovalRevisionDownload/PrintingSingle point access to all document versions

Case Study - StridesChallengesStandardization of location specific requirementsNeed of better visibility and control over their manufacturing practicesIntegration with Legacy documents archived through Parallel Scanning ExerciseFlow of hard copies of controlled documents used to increase operational costsBenefitsIncreased visibility of the issuance process for manufacturingControlled flow of documents onlineTimely automated system alerts/escalationsWatermarkingAutomated checking of Manufacturing License before issuance to productionProfileWorlds largest Soft gelatin capsule manufacturerLeading manufacturer of niche pharmaceutical and nutritional productsProcesses AutomatedProduct Permission (Drug License) ProcessMaster Formula Record (MFR)Master Packaging Record (MPR)Batch Manufacturing Record (BMR)Batch Packaging Record (BPR)Issuance and Execution of Process Orders from SAP

Our ApproachPlatform - not a Point SolutionScale Processes Locations UsersOut of box Template process (L1 , L2 & L3)Pro-agile Implementation methodology (prototypes)Map customer requirement using graphical Process Modeler Configurable real time monitoring platformEnvisaged ROI from DigitizationDigitizationProductivity OptimizationOverheadsComplianceMandatory Norms Adhered toFirst Time RightFraud ControlStandardizationUser UtilizationUser ProductivityTAT ReductionSLA ManagementReduce Exceptions Technology & MaintenanceDisputesCourier Cost Handle 33% More Volume with same usersReduce up to 55% costs on overheadsReduce up to 100%Thank you