“

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.

• 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

With our New LES – Laboratory Execution System

• 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

NBC addressed these challenges and the solution integrates..

Why would we needed an LES

= Sample Tracking (LIMS)

= ELN

= Instrument Connection

Sample Prep

15%

Perform Analysis

40%

Data Entry

15% Solution

Prep

10%

Sample

Submissions

10%

Work

Assignment 5%

Sample

Reporting 5%

Benchtop activities account for 65% of

time spent by laboratory personnel

LIMS addresses

20%

of Laboratory

Operations

Where was the paper?

do part of the job

Work Scheduling

Sample Preparation

Inventory Tracking

Instrument Calibration

Training Records

Standard Procedures

& Bench Sheets

Instrument Reports

Customer Reports / COA

LIMS

SDMS Calibration

Training Inventory

ELN

Previous attempts at reducing paper

need to be Integrated to gain real value

Work Scheduling

Sample Preparation

Inventory Tracking

Instrument Calibration

Training Records

Standard Procedures

& Bench Sheets

Instrument Reports

Customer Reports / COA

LIMS

SDMS Calibration

Training Inventory

ELN/LES

Our solution is totally vendor neutral for instruments

Narragansett Bay Commission

LIMS

SDMS Calibration

Training Inventory

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

Analyst Qualified ? Certified ?

Training ? Present?

Instrument Calibrated ?

Inventory Expired ? Reorder?

Document Management

Instruments

LIMS/ERP/SAP/ Other Informatics

System

Example Form

Instrument Data

Record Retention $1600 per month/month

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Inventory Management

Locate, track and manage materials

Asset Utilization

Monitor usage, optimize investments,

track KPIs

Instrument and Systems Integration

Electronic data transfer, eliminating

manual transcription

Sample Management

Validate Analyses/Samples with ESigs

Electronic Lab Notebooks and Worksheets

Eliminate paper, automate processes and ensure procedural

execution

Execute

Track

Manage

Narragansett Bay puts it all together

Narragansett Bay Commission

Interface

Utilize

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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

Execute

LES

Narragansett Bay Commission

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).”

Sample Collection on iPads

How did we convert our paper forms to electronic?

Current paper forms become electronic forms

Automated Worksheet Automation / Integration Controls

+ = PDF

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

Electronic Notebooks– Real Time Integration…

Narragansett Bay Commission

pH and Percent Titratable Acidity Worksheet

LIMS

Inventory System

Calibration System

Instrument Data

Automated Calculations

Everything is in one place

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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)

Instrument and Systems Integration

Narragansett Bay Commission

Interface

22

Emergence of “Data Discovery and Visualization”

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REPORTING STATS

Highly Structured Predetermined

Questions

Control-based

IT Dependent

Lengthy Ask-To-Answer Loops

“Deep Analytics”

Valuable, But Complicated to use

Limited to Power Users

Lengthy Ask-To-Answer Loops for end-

users

ANALYTICS & DATA

DISCOVERY

Free of Dimensional

Constraints

New Questions

User-Driven

Agile, Self Service

Predictive

Empowerment-based

Too Much Information?

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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.

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Inventory Management

Instrument & Equipment Management

Training and Certification

Asset Utilization

Monitor usage, optimize investments,

track KPIs

Instrument and Systems Integration

Electronic data transfer, eliminate

manual transcription

Laboratory Information Management Systems

Schedule, assign, test, and report

Laboratory Execution System

Eliminate paper, automate processes and ensure procedural

execution

Execute

Track

Manage

iLAB Laboratory Execution System Overview

Narragansett Bay Commission

… an Integrated Platform

Interface

Visualize

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• Business intelligence for laboratory asset

optimization; people, equipment & processes

• Collect, Consolidate and Add Context to Data

• Simple Information in a Usable & Actionable

Format

Bring data into decisions

Insight through visualization

Informed decisions

• Lab Analytics

Utilization data (assets, method, people)

Trend analysis

Comparison analysis

# of samples, injections, and errors

iLAB – Analytics and Visualization

Narragansett Bay Commission

Visualize

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• Visualize data from many sources including

LIMS, SCADA, etc

• Access Spotfire dashboards from within LES

Portal

iLAB – Analytics and Visualization

Narragansett Bay Commission

Visualize

28 28

• Spotfire can be used to recall data from iLAB

• Select worksheet reference in dashboard

that opens read-only view of a completed

worksheet

iLAB – Analytics and Visualization

Narragansett Bay Commission

Visualize

• A worksheet reference was

configured as a URL

• When the URL is followed a

view of the worksheet is

provided

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• 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?

iLAB – Analytics and Visualization

Narragansett Bay Commission

Visualize

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• 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

iLAB – Analytics and Visualization: Setup

Narragansett Bay Commission

Visualize

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Dashboard 1: Track projects by Location, Technician and Priority

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Dashboard 2: Lab Analytics on Delays, Priorities and Productivity

33

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

34 Narragansett Bay Commission

Dashboard 6: Control Charts

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Easy Collaboration and Report Generation All-in-One Solution

Data Mining

Desktop Application

Author dashboard

Update reports

WebPlayer

Online report

Zero-Installation

Read-only Views

Interactive interface

Instrumentation Manager

Project Managers

Technicians Data Warehouse

Data Analysts

Collaborators, Reviewers, End users

Data Analysts

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Narragansett Bay Conclusions

Narragansett Bay Commission

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