1. 1 © 2009 PerkinElmer PerkinElmer Informatics This presentation shows current intentions regarding product features, behaviour, schedules and support, these intention may change without notice as we respond to customer requirements. © 2012. PerkinElmer, Inc., Inc. All rights reserved. CONFIDENTIAL AND PROPRIETARY INFORMATION OF PERKINELMER, INC. Neither this document nor the information contained herein may be copied, reproduced, republished, distributed, disclosed, transferred, or otherwise conveyed without the prior written consent of PerkinElmer, Inc. © 2012 PerkinElmer Delivering the LIMS Promise… A Paperless Lab?

2. 2 Agenda The LIMS Promise Evolving Solutions Benefits…

3. 3 What is a LIMS? L aboratory I nformation M anagement S ystem Wikipedia defines a LIMS as a base set of functionality: Receive and log in of physical sample Assign resources, schedule and track sample testing process Manage* skills equipment and inventory used in sample analysis Retain test results Approve/Reject workflow for test results Report to laboratory “customers” * Manage includes procurement of external resources

4. 4 Sample Submission EquipmentManagement InventoryManagement SkillsManagement Test Approval Test Execution Sample Review Pass Fail Sample Receipt Work Assignment Reporting Traditional LIMS Overview Office Laboratory

5. 5 Where are LIMS found? Contract LaboratoriesManufacturing FacilitiesResearch Organizations Primary infrastructureAdjunct to ERP systemFullfills research experiments Wide variety of samples from multiple customers Raw Materials, Inprocess Sampling, Finished Goods Adhoc requests Finished product: Results fileProduct release, Certificate of Analysis Results File Maximize Efficiency – Minimize cost, turn-around Turn-around time, Continuous Improvement, Searchability Accuracy Assembly-line performance, Quick reconfiguration Assembly-line performance, ERP interface Flexible testing options

6. 6 Why don’t LIMS optimize efficiency? The Big Question.... Reminder…. Receive and log in of physical sample Assign resources, schedule and track sample testing process Manage* skills equipment and inventory used in sample analysis Retain test results Approve/Reject workflow for test results Report to laboratory “customers” All Optimization Gained in the Office

7. 7 “Spending” Manpower…. Testing Requests Stability Samples Process Samples Triggered by ERP Work Assignment Analysts Equipment Reagent/Solution Preparation Sample Preparation Analytical Procedure Test Result Entry Instruments Benchsheets/Worksheets Review & Approval Reporting Lab Management Log books Training Records Inventory Records Equipment Records Calibration PM Scheduling Usage Logs Paper Records Management Working SOPs Benchsheets/Worksheets Records Storage Records Retrieval (audits & Investigations) Sample Submission 5% 10% 15% 5% 20% 25% LIMS Paper LIMS & Paper Paper LIMS Receive Assign Retain & Manage Retain & Manage Approve Report ???

8. 8 LIMS Impact Based on Manpower Allocation

9. 9 Speed up sample turn-around and reduce cost by automating “in-lab” data capture and review  Instrument results  Bench-sheet data using electronic forms with built-in database lookups, business rules Reduce cost of retesting  Non-standard, or not-followed methods  Expired reagents  Un-calibrated instruments  Not certified employees Reduce cost of searching for historical records Insure compliance to government regulations Instrument Results  Integrate “all” instruments to LIMS Benchsheets & Worksheets  Transition to electronic equivalents Delivering the 75%: Laboratory Execution System

10. 10 The Impact of a Laboratory Execution System Results Posted to LIMS Automatically Streamlined Review and Approval of Results LIMS OnlyLIMS + LES Submit Sample, Assign Tests LES worksheets Automatically Assigned to Analysts Verify Training Records Execute SOP in LES Verify Instrument Calibration Verify Chemical Expiry Instrument Results Posted to LES Verify Training Records Execute SOP in LES Verify Instrument Calibration Verify Chemical Expiry Instrument Results Posted to LES Results Arrive, Manual Data Entry Intensive Review and Approval of Results Submit Sample, Assign Tests Assign work (benchsheets) to Analysts WAIT

11. 11 The Impact of Manual Data Entry & Re-Entry

12. 12 Test Results:  50% Instrument Results (frequently transcribed to a benchsheet)  Manual Transcription  Cut and Paste from Excel  50% Benchsheet Results Result Calculations:  Instrument Specific?  Calculator?  Excel? The Impact of Manual Data Entry & Re-Entry “there is a 3% error in each level of transcription, which reduces to 0.5% with checking in a manual process working culture” http://www.limsfinder.com/BlogDetail.aspx?id=3281_0_2_0_C Vishal Rosha Consultant, Satyam Computer Transcription Errors Transcription Time Data Review Errors

13. 13 Electronic Benchsheets and Sample Preparation From LIMS Calibration Inventory To LIMS Calculations Instrument

14. 14 By Performing the Analysis in a Laboratory Execution System (LES)… Control and Document every step of the process Automatic verification of training records Automatic verification of instrument calibration status Automatic verification of chemical expiration dates Collection of complete lab activity metadata Fully automated exchange of information between systems

15. 15 The Laboratory Execution System Payoff… Testing Requests Stability Samples Process Samples Triggered by ERP Work Assignment Analysts Equipment Reagent/Solution Preparation Sample Preparation Analytical Procedure Test Result Entry Instruments Benchsheets/Worksheets Review & Approval Reporting Lab Management Log books Training Records Inventory Records Equipment Records Calibration PM Scheduling Usage Logs Paper Records Management Working SOPs Benchsheets/Worksheets Records Storage Records Retrieval (audits & Investigations) Sample Submission 5% 10% 15% 5% 20% 25% LIMS Paper LIMS & Paper Paper LIMS LES LES & DMS LIMS & LES LES LES & Integration LIMS

16. 16 Sample Submission EquipmentManagement InventoryManagement SkillsManagement Test Approval Test Execution Sample Review Pass Fail Sample Receipt Work Assignment Calibrated? Expired? Certified? Reporting, Dashboards & Analytics LIMS Laboratory Execution Sample Workflow Records Workflow The New LIMS Paradigm

17. 17 Why Isn’t Every Lab “Paperless” Today? Traditional LIMS haven’t historically offered Laboratory Execution Systems  Focus on sample management and highly-repetitive processes  Technology to rapidly create configurable forms non-existent  Electronic Lab Notebooks targeted the R&D community Third-party LES limited penetration  Proprietary database schema  Limited interfacing connections  “Add-on” functionality means “add-on” costs…ROI justification Newer instruments means more and more data Bi-directional interfaces Multi-component tests Changing laboratory landscape Thinner profits Less specialized workforce Instrument Results  Integrate “all” instruments to LIMS Benchsheets & Worksheets  Transition to electronic equivalents

18. 18 Point laboratory solutions to fill-in gaps of existing LIMS in-place today  Laboratory Execution System  Instrument Integration  Inventory Management  Instrument Calibration, Maintenance, Usage Optimization  Stability Testing  Employee Certification Tracking Solutions are designed for fast/flexible deployment  ReDI (Rapid eForm Development and Integration – no coding  Multiple Integration points  Regulatory adherence What is PerkinElmer Doing Differently …

19. 19 Why Isn’t Every Lab “Paperless” Today? Third-party LES limited penetration  Proprietary database schema  Limited interfacing connections  “Add-on” functionality means “add-on” costs…ROI justification Newer instruments means more and more data  Bi-directional interfaces  Multi-component tests Changing laboratory landscape  Thinner profits  Less specialized workforce Instrument Results  Integrate “all” instruments to LIMS Benchsheets & Worksheets  Transition to electronic equivalents

20. 20 The ReDI Concept Existing Laboratory Forms + Automation / Integration Controls = Automated Worksheet

21. 21 Real Time Integration …at the time of execution pH and Percent Titratable Acidity Worksheet LIMS System Inventory System Calibration System Instrument Data Automated Calculations

22. 22 How to know if it might benefit you? Do you use paper in the laboratory? Do you use multiple Excel worksheets? Do you perform multiple re-tests? Do you run multiple, multi-vendor instruments? Are you regulated by the FDA or ISO? Do you have high employee turnover?

23. 23 The LES Payoff… INCREASING Sample Volume Tests per Sample Test Complexity DECREASING Test Time Reporting Time Resources MAINTAIN or IMPROVE Regulatory and Standards Compliance Operational Quality and Accuracy LIMS Test Results Solution Prep Sample Prep Procedure Execution Records Mgmt

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