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MODA™ Solution Overview  x Rapid Testing Solutions / Lonza / 10 August 2010
Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Lonza’s Life-Science Platform Custom Manufacturing  Nutrition Ingredients Microbial Control  Performance Intermediates Therapeutic  Cell Solutions Rapid Testing  Solutions Research Solutions Chemical Manufacturing Biological Manufacturing Development Services  Life Science  Ingredients Bioscience MODA™ Solution Endotoxin Detection Microbiology Informatics  Solutions Support
Rapid Testing Solutions ,[object Object],[object Object],[object Object],[object Object]
Value Proposition ,[object Object],[object Object],[object Object],[object Object]
The Solution Improved Compliance Increased Productivity Expedited Decision Making Paperless, Automated Laboratory MODA ™  Solution Components  Mobile Data Acquisition Flexible Workflow Integration On-Demand Analytics Systems (ERP, LIMS, CAPA) Devices Media
MODA™ Solution: Features ,[object Object],Feature Description Complete Workflow Automates sampling, testing, incubation, and results-entry functions for EM, Utilities and Products; guiding the user and preventing process deviations. Mobile & Flexible Utilizes specialized hardware, RFID, and barcoding technology to automate data capture at the sampling site. Entirely Paperless Eliminates all paper schedules, hand-written notes, reconciliation, and transcription activities. On-Demand Analysis Provides on-demand reporting, tracking, trending, and visualization of critical information without exporting and reformatting data.
MODA™ Solution: Benefits ,[object Object],Feature Description Cost Reduction Significantly less personnel hours on data entry, paperwork, and other clerical functions. Productivity Improvements Collect and process more samples with the same or fewer personnel.  Refocus personnel on value-added activities. Enhanced Compliance Reduced errors and process deviations; faster turnaround of information for CAPA activities and product release. Return on Investment Solution  investment: typically returns positive cash flow in 6-36 mos.  LIMS investments: significantly enhanced with a COTS QC solution.
“ Go Green” with MODA™ Solution
MODA™ Solution: Components MODA-EM™  Client Software to  manage the  entire lifecycle  of EM samples  without paper MODA-FDC™ Mobile Field Data Capture platform for sampling in all critical areas MODA-EM™ Server Database to  store, administer,  and report all  EM data MODA-VIP™ Visual Intelligence Portal, advanced visualization  of EM data
MODA-FDC™ Cart ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison: QC Micro Processes (MODA™ Solution) Rapid Testing Solutions / Lonza
The  Paper-based  QC Process Example: EM Sampling and Lab Processing Print sampling schedule & labels per EM SOP Reconcile planned samples with collected samples Close out sampling schedule per EM SOP Put on sterile outer garments and enter processing area Identify area to collect samples from facility map Collect sample and affix label Record date, time and initials on paper schedule and media Record sample receipt Prepare samples for testing. Report media lot, equipment, dilution info Record incubation start date and time  Incubate samples Record incubation stop date and time Analyze samples and record results Aggregate data Trend results Report results Investigate excursion Trends OK? NO All samples collected All samples accounted for? Deliver sampling paperwork to QC Supervisor  Assign sampling activities to QC Analysts NO YES NO Deliver samples to Microbiology or Biochemistry for processing YES NO Results in range? Notification of Alert or Action YES YES
The  Paperless  QC Process— 11 Steps Removed Example: EM Sampling and Lab Processing Print sampling schedule & labels per EM SOP Reconcile planned samples with collected samples Close out sampling schedule per EM SOP Put on sterile outer garments and enter processing area Identify area to collect samples from facility map Collect sample and affix label Record date, time and initials on paper schedule and media Record sample receipt Prepare samples for testing. Report media lot, equipment, dilution info Record incubation start date and time  Incubate samples Record incubation stop date and time Analyze samples and record results Aggregate data Trend results Report results Investigate excursion Trends OK? NO All samples collected All samples accounted for? Deliver sampling paperwork to QC Supervisor  Assign sampling activities to QC Analysts NO YES NO Deliver samples to Microbiology or Biochemistry for processing YES NO Results in range? Notification of Alert or Action YES YES
Paperless  Efficiency Example Paper 8 hours – Paperless 4 Hours = Savings 4 Hours
The Paper-based QC Process Example: Non-Viable Air Testing
The  Paperless  Process Example: Non-Viable Air Testing
Automated Reporting and Analytics
Demonstration (MODA™ Solution) Rapid Testing Solutions / Lonza

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Lonza Moda Solution Overview 2010 Final 18 Aug2010

  • 1. MODA™ Solution Overview x Rapid Testing Solutions / Lonza / 10 August 2010
  • 2.
  • 3. Lonza’s Life-Science Platform Custom Manufacturing Nutrition Ingredients Microbial Control Performance Intermediates Therapeutic Cell Solutions Rapid Testing Solutions Research Solutions Chemical Manufacturing Biological Manufacturing Development Services Life Science Ingredients Bioscience MODA™ Solution Endotoxin Detection Microbiology Informatics Solutions Support
  • 4.
  • 5.
  • 6. The Solution Improved Compliance Increased Productivity Expedited Decision Making Paperless, Automated Laboratory MODA ™ Solution Components Mobile Data Acquisition Flexible Workflow Integration On-Demand Analytics Systems (ERP, LIMS, CAPA) Devices Media
  • 7.
  • 8.
  • 9. “ Go Green” with MODA™ Solution
  • 10. MODA™ Solution: Components MODA-EM™ Client Software to manage the entire lifecycle of EM samples without paper MODA-FDC™ Mobile Field Data Capture platform for sampling in all critical areas MODA-EM™ Server Database to store, administer, and report all EM data MODA-VIP™ Visual Intelligence Portal, advanced visualization of EM data
  • 11.
  • 12. Comparison: QC Micro Processes (MODA™ Solution) Rapid Testing Solutions / Lonza
  • 13. The Paper-based QC Process Example: EM Sampling and Lab Processing Print sampling schedule & labels per EM SOP Reconcile planned samples with collected samples Close out sampling schedule per EM SOP Put on sterile outer garments and enter processing area Identify area to collect samples from facility map Collect sample and affix label Record date, time and initials on paper schedule and media Record sample receipt Prepare samples for testing. Report media lot, equipment, dilution info Record incubation start date and time Incubate samples Record incubation stop date and time Analyze samples and record results Aggregate data Trend results Report results Investigate excursion Trends OK? NO All samples collected All samples accounted for? Deliver sampling paperwork to QC Supervisor Assign sampling activities to QC Analysts NO YES NO Deliver samples to Microbiology or Biochemistry for processing YES NO Results in range? Notification of Alert or Action YES YES
  • 14. The Paperless QC Process— 11 Steps Removed Example: EM Sampling and Lab Processing Print sampling schedule & labels per EM SOP Reconcile planned samples with collected samples Close out sampling schedule per EM SOP Put on sterile outer garments and enter processing area Identify area to collect samples from facility map Collect sample and affix label Record date, time and initials on paper schedule and media Record sample receipt Prepare samples for testing. Report media lot, equipment, dilution info Record incubation start date and time Incubate samples Record incubation stop date and time Analyze samples and record results Aggregate data Trend results Report results Investigate excursion Trends OK? NO All samples collected All samples accounted for? Deliver sampling paperwork to QC Supervisor Assign sampling activities to QC Analysts NO YES NO Deliver samples to Microbiology or Biochemistry for processing YES NO Results in range? Notification of Alert or Action YES YES
  • 15. Paperless Efficiency Example Paper 8 hours – Paperless 4 Hours = Savings 4 Hours
  • 16. The Paper-based QC Process Example: Non-Viable Air Testing
  • 17. The Paperless Process Example: Non-Viable Air Testing
  • 19. Demonstration (MODA™ Solution) Rapid Testing Solutions / Lonza