Enabling Data Defensibility and Laboratory Productivity Using a Laboratory Execution System Narragansett Bay Commission Providence, RI

Enabling Data Defensibility and Laboratory Productivity Using a Laboratory Execution System Narragansett Bay Commission Providence, RI

Challenges in the QA/QC Space Public and Private labs need to reduce costs without compromising quality Our customers need solutions that let QA/QC maintain their high attention to detail, but that shorten the time and cost required to qualify an area or material for use, and communicate that information quickly to the right people Solutions that can deliver metrics on operational effectiveness and drive the reduction/elimination of non-value added tasks are critical to meeting their business objectives A key factor includes traceability and defensibility, quickly and easily finding your results, raw data, audit trail, approval process, etc.

With our New LES Laboratory Execution System Automatically 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 17025 Certification Narragansett Bay Commission

NBC addressed these challenges and the solution integrates.. Electronic Worksheets to replace all paper in the laboratory ipads to collect field sampling information and metadata Touch screen monitors for sample receipting Automated bi-direction instrument interfacing for all lab equipment SharePoint as the document management system and to capture all lab worksheets HachWIMS software to integrate lab and plant data, and generate reports Integration of 3 wind turbines provide around half of the site s power needs also interfaced to the WIMDS Publishing data to our customers through a web portal Narragansett Bay Commission

Why would we needed 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

Where was the paper? LIMS Inventory Training SDMS Calibration ELN Work Scheduling Sample Preparation Inventory Tracking Instrument Calibration Training Records Standard Procedures & Bench Sheets Instrument Reports Customer Reports / COA do part of the job

need to be Integrated to gain Previous attempts at reducing paper LIMS Inventory Training SDMS Calibration ELN/LES Work Scheduling Sample Preparation Inventory Tracking Instrument Calibration Training Records Standard Procedures & Bench Sheets Instrument Reports Customer Reports / COA

Narragansett Bay Commission Our solution is totally vendor neutral for instruments LIMS Inventory Training SDMS Calibration ELN/LES LEVERAGE EXISTING INVESTMENTS

How does paper impact our lab? Paper based processes introduce risk areas, bottlenecks and costs: Risks Transcription errors (3%-5%) Procedural errors - Deviation from SOP Calculation errors miscalculations (ex. 1+1=3) Transcription errors Illegibility (ex. Was that 3 or 8?) Omissions of data/information Loss / destruction of paper / Illegibility Bottlenecks Data transcription, double and triple transcription of information that already exists Manual calculations Lack of real-time feedback, delays in decisions and actions Costs Hard Costs paper, notebooks, storage, consumables Soft Costs human errors, investigations, corrective actions

Paper forms are easy to use, but disconnected and impede data flow Example Form LIMS/ERP/SAP/ Other Informatics System Document Record Retention Management $1600 per month/month Analyst Qualified? Certified? Training? Present? Inventory Expired? Reorder? Instrument Calibrated? Instruments Instrument Data

Narragansett Bay 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 Utilize Instrument and Systems Integration Electronic data transfer, eliminating manual transcription Asset Utilization Monitor usage, optimize investments, track KPIs 11 Narragansett Bay Commission

LES Execute Laboratory Execution System Sample Centric Repetitive Analysis Procedural Adherence & Execution Leverage existing processes to build an electronic environment Utilize current: Worksheets, bench forms, log books Standard Operating Procedures Zero footprint web browser interface Industry leading ReDI technology enables rapid deployment Implement worksheets in hours vs days Highly integrated to other lab software 12 Narragansett Bay Commission

Field Inspectors The purpose of The NELAC Institute (TNI) National Environmental Field Activities Program (NEFAP) is to establish and implement an accreditation program for field sampling and measurement organizations (FSMOs). Narragansett Bay Commission

Sample Collection on ipads

Current paper forms become How did we convert our paper forms to electronic? Automated Worksheet = PDF Automation / + Integration Controls

Procedures-based ELN dramatically enhances lab productivity 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

Narragansett Bay Commission Electronic Notebooks Real Time Integration ph and Percent Titratable Acidity Worksheet LIMS Calibration System Instrument Data Inventory System Automated Calculations

Everything is in one place

Instrument and Systems Integration Interface Leading interfacing platform for the last 20 years Solution provides the Information Wiring for electronic data transfer in the laboratory Used to integrate instruments & instrument data systems to a wide variety of Enterprise applications including: ELN, LES, LIMS, SDMS, DMS, SAP, etc... Scalable application can be deployed as: Workstation Application on a single PC Client /Server solution supporting centralized database, security and audit components Regulatory compliance (e.g. 21CFR Part11, GxP) 21 Narragansett Bay Commission

22 Emergence of Data Discovery and Visualization

Too Much Information? 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 endusers 23

The NBC 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. 24

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 Visualize Instrument and Systems Integration Electronic data transfer, eliminate manual transcription Asset Utilization Monitor usage, optimize investments, track KPIs 25 Narragansett Bay Commission

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 26 Narragansett Bay Commission

ilab Analytics and Visualization Visualize Visualize data from many sources including LIMS, SCADA, etc Access Spotfire dashboards from within LES Portal 27 Narragansett Bay Commission

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 28 Narragansett Bay Commission

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.. 29 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? Narragansett Bay Commission

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 Webplayer and accessible through URL ilab Portal is configured to load new dashboard 30 Narragansett Bay Commission

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

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

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

Dashboard 6: Control Charts 34 Narragansett Bay Commission

Easy Collaboration and Report Generation All-in-One Solution Data Mining 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 35

Narragansett Bay 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 36 Narragansett Bay Commission