assuring method compliance and “smart data” in a paperless...

© 2009 PerkinElmer © 2009 PerkinElmer

Assuring Method Compliance and “Smart Data” in a Paperless

Environment

NEMC 2013 San Antonio TX

John Nobles

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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

Laboratory Execution System Overview

… an Integrated Platform

Interface

Visualize

Procedures based LES 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

- Storage and Retrieval Concerns

- Ultimately no control

- Not to mention all the associated costs

- Legible text

- All information electronically traced

- Selection from pre-defined lists

- Electronic signature

- Insert image electronically (Easily and Quickly retrieved)

- Controlled execution –step by step

Paperless Bench Sheets – Real Time Integration…

…ENFORCE EVERY STEP OF THE SOP/METHOD

pH and Percent Titratable Acidity Worksheet

LIMS

Inventory System

Calibration System

Instrument Data

Automated Calculations

Electronic Bench Sheets look exactly like your current forms…

…No training for laboratory personnel

Method Compliance with LES

Is the analyst qualified?

Is training up to date?

No

Is this an approved

instrument?

No

No

Has the instrument been

calibrated?

Is their sufficient reagent?

No

Is the reagent valid?

No

No

Truly Vendor Neutral

Work with any existing technologies

LIMS

SDMS Calibration

Training Inventory

ELN/LES

LEVERAGE EXISTING

INVESTMENTS

Scenario One – Disparate Databases

THE SAGA OF A HAMBURGER

• A significant obstacle to the consistent data exchange deliverables are the sheer number of networks and reporting requirements. Following public consumption of a tainted hamburger, a laboratory must:

• Send the data to FDA if it’s the lettuce, ketchup, mayo, or bun • Send the data to USDA if it’s the meat • Send the data to CDC and the state lab if someone became ill • If it is a biological contamination, send the data to one CDC network • If it is a chemical contaminant, send the data to a different CDC network • Send the data to EPA if the food was contaminated due to environmental concerns • Different EPA networks exist for water, waste, air and response mitigation. • Lab data must be formatted for each program and then sent through multiple

networks. • A single laboratory section in EPA RTP, NC has over 50 disparate segmented

databases. • How many does your lab have?

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Inventory Management

Instrument & Equipment Management

Training and Certification

Data Mashup and Mining

Dashboards on-the-fly

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

Laboratory Execution System Overview

… an Integrated Platform

Interface

Visualize

Without a common deliverable format, how do we..

Emergence of Data Discovery and Visualization

“SMART DATA”

Spotfire for data mining

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

ERP Systems

CRM Systems

Custom & Legacy Applications Data

Warehouse

Desktop Productivity

Tools

Statistical Applications

Empowers users to freely explore their data Not limited by predefined views or aggregations

No barriers or delays—no IT programming required

Users can answer their questions without restriction Ad hoc data analysis

Freely move from known to unanticipated questions

Fastest to actionable insight

Universal analytics platform Applicable across any process, function, or use case

Data visualization, predictive analytics, event-driven analytics

Analytic Dashboards for better decision making across the organization

First to insight. First to Action.

The Spotfire Approach

CDC

EPA

USDA eLEXNET

FERN

Data Docs

Combine data from any external

data source or application

More context → greater insight in

your analysis

Transform and analytically

enhance your data

… dashboards and mashup from disparate sources

Unlock Insights in your extended enterprise…Scenario One

Chemical

Inventory Sample Data

and Results

Instrument

Calibration

Personnel

Plant

Data

Lab

Data Docs

Combine data from any internal

data source or application

More context → greater insight in

your analysis

Transform and analytically

enhance your data

… single entity may have multiple non-integrated data repositories.

Unlock Insights in your local enterprise…Scenario Two

Lab Execution System & Data Mining

Paperless LES to enforce method compliance

Data Mashup and Visualization

Key Features • Interactive Summary Views with

– Dynamic Values – Wide range of Conditional Icons – Sparklines

• Drill-down navigation • Driven by filters, user control

Key Benefits • Key metrics at a glance

• Quickly see everything needed on a single screen

• Easily & intuitively spot patterns, exceptions, trends and outliers

• Quickly drill into details when needed

…increase productivity and improve data-driven decision making!

Analytic Dashboards

• Fixed size layouts to optimize for specific devices and screens

• Single click page history navigation

• Preserve information when switching visualizations

• Change all fonts/text sizes at once

• Easier access to toggling visualization features

• More predefined categorical coloring schemes

• Easier to manage document color schemes

…create reports with fewer clicks

Easy to Build Dashboards

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• Efficiently organize day-to-day work in the Lab

Track, assign & manage requests & report the results

Monitor testing progression

Monitor backlogs

• Test Metrics

Track tests per user/technician

Track amount of tests per requestor

• Lab Management

Transparence system to track amount of work requested for each piece of instrument

Monitor total amount of the time when instrument is down per year

Prioritize limited number of requests per requestor

• Project Management

Assign est. cost to each test to understand value of tests

Track total cost of spend per project

Project/test priority capability

Track amount of tests per project

…quick insight to the data

… can be used to create Lab Management Dashboards

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Use Excel-like tools

Example Dashboard : Track projects

Lab Analytics on Delays, Priorities and Productivity

Asset Optimization: People, Equipment, Supplies & Processes

Testing results and Criteria Selection

Monitor Usage, Optimize Process, Track KPIs

Control Charts

Easy Collaboration and Report Generation All-in-One Solution

• SPOTFIRE – Desktop Application – Author dashboard – Update reports

• Web Player – Online report – Zero-Installation – Read-only Views – Interactive interface

Instrumentation Manager

Project Managers

Technicians Data Warehouse

Data Analysts

Collaborators, Reviewers, End

users

Data Analysts

Dynamic Dashboards

Aquifers and Rock Types

Spotfire Demonstration

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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

Laboratory Execution System Overview

… an Integrated Platform

Interface

Visualize

Automating Data Collection and Review

Without a LIMS that can manage and link this data, laboratories must manually input the quality control data into the results message. This adds a significant burden not only on the reporting laboratory but also on the data user, and increases the chances of errors in the data.

Typical QC Parameters

The analytical results associated with the analysis of a batch of targets and quality control samples is known as the analytical sequence. Different methods and different programs or clients may require different analytical sequences. Below is an inclusive example of what might be included in one analytical sequence: • Instrument Blank • Initial Calibration • Initial Calibration Validation • Lab Reagent Blank or Method Blank • Lab Fortified Blank or Laboratory Control Sample • Matrix Spike • Matrix Spike Duplicate • Target Samples (typically 10) • Continuing Calibration Verification • Continuing Calibration Blank • Target Samples (typically 10) • Continuing Calibration Verification • Continuing Calibration Blank

Data Elements for Type 2 Submission

• Project Details • Data Package Identifier • Date Format • Laboratory Narrative • Laboratory Qualifiers Definition • Project Identifier • Organization Details • Organization Identifier • Method Details • Method Identifier • Sample Details • Sample Identifier • Sample Chain of Custody Identifier • Sample Collection End Date • Sample Matrix • Sample Type • Analysis Details • Analysis Batch Identifier • Analysis End Date • Analysis Start Date • Analysis Type • Instrument Identifier • Laboratory Analysis Identifier • Method Identifier • Substance Identification Details • Exclusion Indicator • Reporting Limit • Reporting Limit Type • Reporting Limit Units • Result • Result Units • Substance Name • Substance Type • Run Batch Identifier

Any Instruments, Any LIMS, Any Metadata

• Uni-Directional Interfaces – One way transfer of data from instrument to LIMS – Simplest to implement – Eliminates transcription errors

• Bi-Directional Interfaces

– Two way transfer of data between instrument and LIMS – Leverages sample and test information that resides in LIMS

• Reduces effort and errors

• Integration with CDS – TotalChrom, Chemstation, Empower

– Two way transfer of data between CDS and LIMS – All interaction is initiated from within the CDS client

LIMS

Instrument

LIMS

Instrument

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Some Instruments that have been Interfaced with LimsLink

Integrated Applications

LES

Inventory

LIMS

Interface

Utilization

Training

Spotfire

Calibration

SharePoint

Integrated Laboratory Platform

…maximize productivity and ensure quality