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Enabling Digital Transformation in Life Sciences Industry

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Enabling Digital Transformation in Life Sciences Industry

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Enabling Digital Transformation in Life Sciences Industry

  1. 1. Digital Transformation for Healthcare & Life Science www.newgensoft.com
  2. 2. Agenda
  3. 3. CEO Top Priority Source: PWC 2015
  4. 4. Growing Challenges • Highly Document Intensive • Ever Changing Regulatory Compliances • Visibility across all Processes • Scaling process and operations • Monitoring Productivity, SLA, TATs • Change & Transition management
  5. 5. Newgen Overview 1200+ Customers 1 of 3 vendors to feature in MQs for iBPMS, ECM & CCM 58 Countries 200+ Partners 1600+ Employees 100+ Healthcare Customers globally 40+ Patents World’s largest ECM Project in Insurance Sector with 9 Billion docs ECM MQ “Visionary Quadrant” Investors Offices Singapore USA • Florida • Washington DC Canada UK UAE India • New Delhi • Mumbai • Chennai
  6. 6. Industry Recognized Product Portfolio Gartner MQ for Enterprise Content Management Gartner MQ for Intelligent Business Process Management Suites Gartner MQ for Customer Communication Management Gartner MQ for Case Management Report
  7. 7. Global Presence: Marquee Customers BFSI Finance BPO & Shared Services Health Care & Life Sciences
  8. 8. Newgen Product Portfolio
  9. 9. Product Logical Architecture Straight Through Process Heads Down Production Process Collaborative Human Process Semi Structured Process Fully Unstructured Process 1 2 3 Gateways • Web Services • JMS • Web APIs • UI Integration • Advanced Terminal Emulator Integration Adaptors iBPMS Components Process Initiation Fax Event Scan MobileEmail Portal Process Execution Engine Business Activity Monitoring Social Media Integration Process Modeler Content Management Process Simulator Mobile Integration Adaptor Business Rules Management System CEP Analytics
  10. 10. Newgen Solution iBPM ECM Process Accelerators Content Capture Appeals & Grievances Quality & Manufacturing Process Employee On-Boarding Art Work Management Provider Contracting Patient Record Mgmt Infrastructure Database ServersConnectivity Procure To Pay Record To Report F&A Processes Legacy Applications
  11. 11. Pharma: Solution Accelerators Goods Manufacturing Process Document Lifecycle Management • Standard 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
  12. 12. Healthcare Payer: Solution Accelerators Member Enrollment Provider Contracting Appeals & Grievances Claims Management
  13. 13. Solution Accelerators for Hospitals Document Lifecycle Management • Legal Contracting and Maintenance • F&A Documents Management • Electronics Customer Health Records • Central SOP Repository • Records Management • Document Acquisition Management • Patient Record Management Electronic Medical Record Complaints Management Consent Management Customer Communication Management
  14. 14. Finance and Accounts • Transactional • Accounts Payable (AP) or Procure-To- Pay (PTP) • Accounts Receivable (AR) or Sales- Order-To-Cash (SOTC) • PO Approval • Order to Cash • Collections • General Ledger (GL) or Records-To- Reports (RTR) • Fixed Assets Management (FA) or CAPEX Management • Tender Processing / Quotation Management • Freight Bill Processing – Inward & Outward • Master Data Management • Vendor Master • Price Master • Item Master • Vendor/Consultant Agreements • Lease & Agreements • Query Resolution • Vendor Query Management Human Resources • Employee Reimbursements • Travel & Expense • Medical Claims • PL Encashment • Advance Request • Payroll Additions/ Deductions • Leave Management • Contract Management • Hire-to-Retire • Indent • On boarding • Ongoing Appraisals • Exit Formalities Admin • Service Request Process • Travel desk Management • Suggestion Scheme Process SSC: Process Accelerators
  15. 15. Quality & Manufacturing Solution for Pharmaceuticals
  16. 16. Cost of GMP* Non-Compliance Leading Pharmaceutical Drug Manufacturer found non - compliant to GMP standards by FDA 73 out of 125 drugs put on Consent Decree list by FDA Production suspended for drugs on list Nearly $250 million lost in profits for a single drug on the decree list in 1 year $500 million paid out in fines * 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=102280 2. © 2011, Daratech, Inc, Cambridge, MA, USA Reference. 8.178 (charts-ecmppv-pie-1.gif) $1,000,000 Production Interruptions Cost per day due to halted production Consent Decree Fines for failing to comply with GMP or other federal requirements $50-500 mn $5 to $975K Legal Fines for violations of environmental regulations by manufacturing facilities
  17. 17. GMP Compliance - Challenges and Risks Difficulty in managing myriad types, multiple versions and large volumes of pharmaceutical documents Inaccurate documentation produced during Regulatory Audits for GMP Compliance Regulatory Warnings & Denial of Drug Entry into Market Drug Revenue Loss
  18. 18. Newgen Quality & Manufacturing Solution for Pharmaceuticals • Complete Document Lifecycle Management • Out of Box compliance with FDA 21 CFR part 11 regulations • Increased productivity and quicker employee TBR training on SOP documents Document Lifecycle Management • Ensured right document delivery at various production steps • Controlled access to all documents from single repository Strong Checkpoints for Batch Production • Fast access to documents and document audit details required during GMP compliance audits Compliance Desktop
  19. 19. Newgen Solution Features Newgen Solution Feature Set Content Creation Dictionaries and Taxonomies Document Templates Auto-Naming/Linking Content Lifecycle Management Workflow Task Notification Change Control Version Management Content Transformation PDF Rendering Overlay Watermark Controlled Printing PDF Annotation Content Compliance Electronic Signature Audit Trail Search Reporting Dashboards Support for 21 CFR Part 11
  20. 20. Document Lifecycle Management Document Authoring Document Review Document Approval Quality Check Effective and Revised Versions Controlled Document Usage  Automated workflow for online document review-approval  Flexible workflow definition  System managed document states  Draft, In Review, At Approval, QA Pending Release, Effective, Superseded  Automatic PDF rendering & watermarking of document  Automatic document version management  Controlled document access & printing  Configurable document related states, types and metadata
  21. 21. HOD Initiates Document Creation HOD • Initiates document creation • Captures document details (metadata) • Select workflow for review –approval of draft document
  22. 22. Author Checks Out Document Template Author • Checks out document template for creating draft • Checks –in, e-signs and submits draft document for review
  23. 23. 21 CFR Part 11 Compliant  Solution satisfies CFR 21 part 11 requirements for e-signatures  Documents e-signed using unique combination of username and password at each stage of document creation/revision lifecycle  Signatures appended to document contain:  Name of signer  Data and time of executing signature  Reason for executing signature
  24. 24. 21 CFR Part 11 Compliant  Signatures appended to document contain  Name of signer  Reason for executing signature  Data and time of executing signature
  25. 25. Reviewer –Approver Annotates Document Rendition Reviewer/Approver • Review draft document rendition • Specify review comments using annotations • Send document back to author/ send forward for Approval & QA check
  26. 26. Two Document View • Reviewer can view previously annotated document and newly corrected document sent by author side by side
  27. 27. Quality Assurance User Sets Effective Date Quality Assurance User • Perform final check of document rendition • Specify review comments using annotations • Send document back to approver/ set effective date for document
  28. 28. View List of Recently Effective Documents
  29. 29. 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
  30. 30. System Controlled Document Delivery for Batch Production Batch number attached to document issued to production user
  31. 31. Compliance Desktop for Document Access • Instant online document access using Full Text Search and Advanced meta data search • Controlled access and printing of documents • Quick access to document audit details for compliance audits
  32. 32. Access Document Audit Trails  System maintained audit trails about all document related user actions including:  Authoring  Check-out/Check-in  Rejection  Review, Approval  Revision  Download/Printing  Single point access to all document versions
  33. 33. Case Study - Strides Challenges • Standardization of location specific requirements • Need of better visibility and control over their manufacturing practices • Integration with Legacy documents archived through Parallel Scanning Exercise • Flow of hard copies of controlled documents used to increase operational costs Benefits • Increased visibility of the issuance process for manufacturing • Controlled flow of documents online • Timely automated system alerts/escalations • Watermarking • Automated checking of Manufacturing License before issuance to production Profile • World’s largest Soft gelatin capsule manufacturer • Leading manufacturer of niche pharmaceutical and nutritional products Processes Automated • Product Permission (Drug License) Process • Master Formula Record (MFR) • Master Packaging Record (MPR) • Batch Manufacturing Record (BMR) • Batch Packaging Record (BPR) • Issuance and Execution of Process Orders from SAP
  34. 34. Our Approach • Platform - not a Point Solution • Scale Processes Locations Users • Out of box Template process (L1 , L2 & L3) • Pro-agile Implementation methodology (prototypes) • Map customer requirement using graphical Process Modeler • Configurable real time monitoring platform
  35. 35. Envisaged ROI from Digitization Digitization Productivity Optimization Overheads Compliance Mandatory Norms Adhered to First Time Right Fraud Control Standardization User Utilization User Productivity TAT Reduction SLA Management Reduce Exceptions Technology & Maintenance Disputes Courier Cost Handle 33% More Volume with same users Reduce up to 55% costs on overheads Reduce up to 100%
  36. 36. Thank you

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