Addressing the Automa8on Gap in SOPdriven

Transcription

1 Addressing the Automa8on Gap in SOPdriven Laboratories Jerry Lominac Public Sector Informa8cs Accounts 2009 PerkinElmer

2 Challenges in the QA/QC Space Public and Private labs need to reduce costs without compromising quality Our customers need solu8ons that let QA/QC maintain their high aken8on to detail, but that shorten the 8me and cost required to qualify an area or material for use, and communicate that informa8on quickly to the right people Solu8ons that can deliver metrics on opera8onal effec8veness and drive the reduc8on/elimina8on of non value added tasks are cri8cal to mee8ng their business objec8ves A key factor includes traceability and defensibility, quickly and easily finding your results, raw data, audit trail, approval process, etc.

3 With the New LES Laboratory Execu8on System Automa8cally Enforce all SOPs and Methods Connect field samplers directly to the lab Verify instrument calibration Check reagent expiry and reorder Verify Analyst Certifications Store worksheets electronically Check Specs before committing to LIMS e-signatures on all transactions if desired Enable the lab to become paperless Facilitate TNI/ISO Cer8fica8on

4 Why would I consider an LES = Sample Tracking (LIMS) = ELN = Instrument Connection Sample Prep 15% Perform Analysis 40% Solution Prep 10% Data Entry 15% LIMS addresses 20% of Laboratory Operations Sample Submissions 10% Work Assignment 5% Sample Reporting 5% Benchtop activities account for 65% of time spent by laboratory personnel

5 AKempts to reduce paper and enforce compliance LIMS Inventory Training SDMS Calibra5on ELN do part of the job

6 Standalone technologies LIMS Inventory Training SDMS Calibra5on ELN/LES need to be Integrated to gain real value

7 Truly Vendor Neutral LIMS Inventory Training SDMS Calibra5on ELN/LES Work with any exis8ng instruments and LIMS

8 How is PerkinElmer Informa8cs doing it differently Offer a comprehensive suite of integrated solu8ons ilab ipad, Tablet PC, PC web based solu8on Solu8ons designed to leverage exis8ng investments Solu8ons designed for fast deployments It is the paper, but it s more than the paper. It s all the the problems that come with the paper. It s the errors and the produc8vity. (FLDEP)

9 How does paper impact my lab? Paper based processes introduce risk areas, boklenecks and costs: Risks Transcrip8on errors (3% 5%) Procedural errors Devia5on from SOP Calcula8on errors miscalcula8ons (ex. 1+1=3) Transcrip8on errors Illegibility (ex. Was that 3 or 8?) Omissions of data/informa8on Loss / destruc8on of paper / Illegibility BoKlenecks Data transcrip8on, double and triple transcrip8on of informa8on that already exists Manual calcula8ons Lack of real 8me feedback, delays in decisions and ac8ons Costs Hard Costs paper, notebooks, storage, consumables Soj Costs human errors, inves8ga8ons, correc8ve ac8ons

10 Paper forms are easy to use, but disconnected and impede data flow Document Record Retention Management $1600 per month/month Analyst Qualified? Certified? Training? Present? Instruments Instrument Data

11 ilab puts it all together Execute Electronic Lab Notebooks and Worksheets Eliminate paper, automate processes and ensure procedural execution Manage Sample Management Validate Analyses/Samples with ESigs Track Inventory Management Locate, track and manage materials Interface U5lize Instrument and Systems Integration Electronic data transfer, eliminating manual transcription Asset Utilization Monitor usage, optimize investments, track KPIs 11 Laboratory Plalorm

12 ilab LES Execute Laboratory Execu8on System Sample Centric Repe88ve Analysis Procedural Adherence & Execu8on Leverage exis8ng processes to build an electronic environment U8lize current: Worksheets, bench forms, log books Standard Opera8ng Procedures Zero footprint web browser interface Industry leading ReDI technology enables rapid deployment Implement worksheets in hours vs days Highly integrated to other lab sojware 12

13 ilab Asset U8liza8on U5lize Business intelligence for laboratory asset u8liza8on Collect, Consolidate and Add Context to Data Simple Informa8on in a Usable & Ac8onable Format Lab Analy8cs Data into decisions Insight through visualiza8on Informed decisions U8liza8on data (assets, method, people) Trend analysis Comparison analysis # of samples, injec8ons, and errors Any technology, instrument or manufacturer 13

14 Instrument Calibra8on Addi8onal LES Components Training Records Connectors Collect calibration data directly from instruments Automate calibration SOPs ensuring data integrity and consistency Integrate with analytical SOPs, ensuring that only calibrated instruments are used for testing Automate scheduling of calibrations, maintenance and repairs Assigning training by individual, job function or workgroup Record attendance, completion of courses and scheduling of retraining Send reminders Electronic search and retrieval of training related documents and record Commercially supported interfaces Utilizes standard APIs of host system Full bi-directional support of systems transactions Systems support include: SAP SharePoint KnowledgeTree Openlab ECM

15 Field Inspectors The purpose of The NELAC Ins8tute (TNI) Na8onal Environmental Field Ac8vi8es Program (NEFAP) is to establish and implement an accredita8on program for field sampling and measurement organiza8ons (FSMOs).

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17 How do we make this happen in my lab???

18 This is the PerkinElmer Differen8ator Your Worksheets

19 How does Rapid e Form Development work? Automated Worksheet = PDF Automa8on / + Integra8on Controls Current paper forms become electronic forms

20 Procedures based ELN drama8cally enhances lab produc8vity Problems with paper Benefits of Automation - Illegible handwriting/transcription errors - Information recorded where it should not be - Image printed/pasted onto page - Ultimately no control Legible text - All information electronically traced - Selection from pre-defined lists - Electronic signature - Insert image electronically - Controlled execution step by step

21 Ensemble for QA/QC Real Time Integra8on ph and Percent Titratable Acidity Worksheet LIMS Calibration System Instrument Data Inventory System Automated Calculations ENFORCE EVERY STEP OF THE SOP/METHOD

22 Nexxis ELN looks like your current forms

23 But everything is in one place

24 LimsLink Instrument and Systems Integra8on Interface Leading interfacing plalorm for the last 20 years Solu8on provides the Informa8on Wiring for electronic data transfer in the laboratory Used to integrate instruments & instrument data systems to a wide variety of Enterprise applica8ons including: ELN, LES, LIMS, SDMS, DMS, SAP, etc... Scalable applica8on can be deployed as: Worksta8on Applica8on on a single PC Client /Server solu8on suppor8ng centralized database, security and audit components Regulatory compliance (e.g. 21CFR Part11, GxP) 24

25 25 What Instruments have been Interfaced with LimsLink?

26 26 Emergence of Data Discovery and Visualization

27 TMI? ANALYTICS & DATA DISCOVERY REPORTING Highly Structured Predetermined Questions Control-based IT Dependent Lengthy Ask-To-Answer Loops Free of Dimensional Constraints New Questions User-Driven Agile, Self Service Predictive Empowerment-based STATS Deep Analytics Valuable, But Complicated to use Limited to Power Users Lengthy Ask-To-Answer Loops for end-users 27

28 The TIBCO Spotfire Analytics Platform Exploratory analysis, dashboard apps & predictive analytics. Easy, Fast and Smart for visualizing and understanding any data. We help people make better decisions, spot new opportunities, and avoid risks. 28

29 The TIBCO Spotfire Platform Delivers Unrivaled Value FASTEST TO ACTIONABLE INSIGHT Anticipate, answer & act on answers to relevant questions at the speed of thought 29 VISIBILITY INTO THE UNKNOWN Uncover trends, patterns, & unexpected insights hidden in data SELF-SERVICE DISCOVERY Enable users to freely manipulate & explore data without relying on IT UNIVERSAL ADAPTABILITY A single highly-scalable platform that empowers business & technical users across all use cases Sales and Specialists Devoted to Spotfire

30 Dimension-free Data Exploration Data Mashup Freely explore data without the need for IT tasks such as creating complex queries, modeling dimensions, or defining navigational paths. Combine data from disparate sources to gain a comprehensive view of the business & make better decisions faster 30

31 ilab Laboratory Execution System Overview Execute Laboratory Execution System Eliminate paper, automate processes and ensure procedural execution Manage Laboratory Information Management Systems Schedule, assign, test, and report Track Inventory Management Instrument & Equipment Management Training and Certification Interface Instrument and Systems Integration Electronic data transfer, eliminate manual transcription Visualize Asset Utilization Monitor usage, optimize investments, track KPIs 31 an Integrated Platform

32 ilab Analytics and Visualization Visualize Business intelligence for laboratory asset optimization; people, equipment & processes Collect, Consolidate and Add Context to Data Simple Information in a Usable & Actionable Format Lab Analytics Bring data into decisions Insight through visualization Informed decisions Utilization data (assets, method, people) Trend analysis Comparison analysis # of samples, injections, and errors 32

33 ilab Analytics and Visualization Visualize Visualize data from many sources including LIMS, SCADA, etc Access Spotfire dashboards from within LES Portal 33

34 ilab Analytics and Visualization Visualize Spotfire can be used to recall data from ilab Select worksheet reference in dashboard that opens read-only view of a completed worksheet A worksheet reference was configured as a URL When the URL is followed a view of the worksheet is provided 34

35 ilab Analytics and Visualization Visualize All data is cross-linked to help the user analyze the data more effectively Facilitates rapid data drill down Typical scenario: Find reason for testing delays in laboratory Select one an area in one chart and highlight those selections in others Reduce data in table to the selected items only.. Initial finding; Analysts completing work in timely fashion but approvers appear to be the cause of the delays. Is it one approver? Why the delay? Procedural issue? 35

36 ilab Analytics and Visualization: Setup Visualize New dashboards configured as needed Dashboard can mash up data from external sources in addition to ilab Dashboard can be configured to provide guided analytics for infrequent users Dashboards can be used outside of ilab environment when appropriate Dashboard is stored in Spotfire Webplayer and accessible through URL ilab Portal is configured to load new dashboard 36

37 37 Dashboard 1: Track projects by Location, Technician and Priority

38 38 Dashboard 2: Lab Analytics on Delays, Priorities and Productivity

39 39 Dashboard 3: Business Intelligence for Laboratory Asset Optimization; People, Equipment & Processes

40 40 Dashboard 6: Control Charts

41 Easy Collaboration and Report Generation All-in-One Solution TIBCO SPOTFIRE Desktop Application Author dashboard Update reports Data Analysts Instrumentation Manager Collaborators, Reviewers, End users Technicians Data Analysts Data Warehouse Project Managers WebPlayer Online report Zero-Installation Read-only Views Interactive interface 41

42 LES Conclusions LES integrates people, procedures and lab systems to provide real time workflow control at the bench level and assure defensible data Maintain high attention to detail while reducing the time and cost required to qualify an area or material for use Quickly communicate critical information to support business decisions Deliver metrics on operational effectiveness and drive the reduction/elimination of non-value added tasks Reduce the time and effort needed to capture, document, and manage data 42 to drive productivity