Developing Database Query Proficiency: Assuring Compliance for ...
Assuring Method Compliance and “Smart Data” in a Paperless...
Transcript of 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