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?
Slide 2
2 Agenda The LIMS Promise Evolving Solutions Benefits
Slide 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
Slide 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
Slide 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
Slide 6
6 Why dont 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
Slide 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 ???
Slide 8
8 LIMS Impact Based on Manpower Allocation
Slide 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
Slide 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
Slide 11
11 The Impact of Manual Data Entry & Re-Entry
Slide 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
Slide 13
13 Electronic Benchsheets and Sample Preparation From LIMS
Calibration Inventory To LIMS Calculations Instrument
Slide 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
Slide 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
Slide 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
Slide 17
17 Why Isnt Every Lab Paperless Today? Traditional LIMS havent
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 costsROI 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
Slide 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
Slide 19
19 Why Isnt Every Lab Paperless Today? Third-party LES limited
penetration Proprietary database schema Limited interfacing
connections Add-on functionality means add-on costsROI
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
Slide 20
20 The ReDI Concept Existing Laboratory Forms + Automation /
Integration Controls = Automated Worksheet
Slide 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
Slide 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?
Slide 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
