Modern business drivers are continually pushing to reduce the time it takes to get a product or service to market, reduce the risk and cost associated with that, and to improve quality. In laboratories, delivering an analytical result that’s ‘right first time’ (RFT) is the answer. There is no reprocessing data or re-running injections and no out of specification (OOS) results or reporting/calculation errors. Using chromatography data system tools for RFT analysis automatically gives high quality of results and confidence in results, lower cost of analysis, improved lab efficiency, and faster release to market and return on investment (ROI).

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The world leader in serving science
Darren Barrington-Light
Product Specialist, Chromatography Software,
Thermo Fisher Scientific
July 16, 2014
Getting It “Right First Time” Seminar
Series – Part 5
Part Number: PP71236-EN 0614S

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Agenda
• Introduction
• How to get it right the first time
• Thermo Scientific™ Dionex™ Chromeleon™ Chromatography
Data System (CDS) tools for RFT analysis
• Reporting and Report Check
• Summary

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Introduction
• Modern business drivers are continually pushing to reduce the
time it takes to get a product or service to market, reduce the
risk and cost associated with that, and to improve quality
• In laboratories, delivering an analytical result that’s ‘right first
time’ (RFT) is the answer
• No reprocessing data or re-running injections
• No out of specification (OOS) results or reporting/calculation errors
• Getting RFT analysis automatically gives:
 High quality of results and confidence in results
 Lower cost of analysis
 Improved lab efficiency
 Faster release to market and return on investment (ROI)

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How to Get It Right the First Time?

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How to Get It Right The First Time?
• Reasons things don’t go right the first time:
• “Human operators are one of the biggest
sources of errors in any complex system”
• An experienced analyst who is 100% focused
can still make 5 errors in 1000 simple data
entries (0.5%)
• But what if they are inexperienced, aren’t
100% focused, or doing a complex task?
• Can rise 10 fold (5%)
• Other factors:
• Lack of preparation
• Rushing the task
• Lack of attention
• Leaving things undone

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How to Get It Right the First Time?
• Robust and reliable instrumentation
• Qualification automation
• Monitor instrument status
• Robust, reproducible, and reliable methodology
• Standard operating procedures
• Method validation
• Automated sequence creation
• Run-time checks
• In-run reactions to actual chromatographic results
• Automated result calculation and export
• Operators
• Make learning curve as shallow as possible
• Provide tools to help inexperienced users with more complex tasks

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Chromeleon CDS Tools for RFT Analysis

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Chromeleon CDS Tools for RFT Analysis
• Instrumentation
• Predictive performance – instrument qualification, service and wear part
monitors
• Methodology
• ICH Method Validation Templates
• eWorkflows™
• Sequence Ready Check
• Smart Startup
• System Suitability Test (SST) with Intelligent Run Control (IRC)
• Spreadsheet-based Report Designer with integral Report Check
• Operators
• Provide processing tools e.g. Cobra™, SmartPeaks™, SmartLink, etc.
• All the above combine to ensure ANY operator can achieve RFT analysis

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Report Designer

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Report Designer
• To meet reporting requirements customized reports often
need to be created
• Limited chromatography reporting options
• Additional calculations might be required to obtain final results
• To avoid this, results are frequently transferred to a
spreadsheet, e.g. Microsoft® Excel
• Time consuming
• Error prone - transcription errors
• No dynamic updating
• No spreadsheet versioning / change tracking
• Remove the “human error” factor  automation

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Chromeleon CDS – Report Designer

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Chromeleon Report Templates…
… can have as many worksheets as required
1
2
Many

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Chromeleon Report Templates…
… can contain text and variables
Text Variables VariablesText

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Chromeleon Report Templates…
… can include result tables
Peak Tables
Summary Tables
Audit Trails
and many others!

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Chromeleon Report Templates…
… can include various plot types
Chromatogram
Calibration
UV Spectrum
Mass Spectrum
Injection Rack

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Chromeleon Report Templates…
… and can even include custom equations…

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Chromeleon Report Templates…
… to create the report you need.

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Example 1: Report in Microsoft Excel

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Example 1: Report in Chromeleon CDS

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Example 2: Calculations in SOP

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Example 2: Calculations in Chromeleon CDS

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Example 3: Calculations in Pharmacopeia
• Content Uniformity
• Dissolution

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Example 3: Calculations in Chromeleon CDS
• Content Uniformity • Dissolution

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Report Check

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Report Check
• Customized reports require error checking and validation
• Time consuming
• Difficult to locate errors
• Chromeleon CDS provides a built-in error check for report
templates:
• Automatic check for every entry in the entire report
• Simple interface to easily correct any errors

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Report Check
• Saves time
• Increases reliability
• Simplifies report validation
Error and location
Automatic Selection
Immediately fix error

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Chromeleon Reports for Data Mining

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Data Mining – Reporting the Right Data
• Sometimes it is required to report specific data
• All injections where the amount of a component is above a certain level
• All Check Standards from a specific analysis
• All injections that failed a System Suitability Test (SST)
• All injections from all instruments in a lab from the past year
• …
• This can be like searching for a needle in a haystack
• Find single or multiple samples in data structure or database
• Collated data needs to be reported

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Data Mining – Injection Query
Query always
available
Search Criteria
Query Results
Associated
Reports

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Data Mining – Injection Query Report

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Data Mining – Instrument Usage Statistics

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Live Demo
• Let’s have a look at the reports, Report Check and Injection
Queries in action …

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Summary

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Summary
• Modern business drivers are continually pushing to reduce the
time it takes to get a product or service to market, reduce the
risk and cost associated with that, and to improve quality
• Not doing a task right the first time usually creates more work
“We had a fundamental belief that doing it right the first time was going to
be easier than having to go back and fix it. And I cannot say strongly
enough that the repercussions of that attitude are staggering” (Steve Jobs)
• Improving quality doesn’t always mean more work
“Quality is free, provided [the task] is done right the first time”
• and my favorite…
“Genius is the ability to evade work by doing something right the first time”

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Summary
• Report Designer
• Powerful and versatile spreadsheet-based reporting engine with easy
customization to show results as required
• Instant automatic update when source data changes
• No transcription errors, compliant
• Report Check
• Increases report reliability and simplifies report validation
• Injection Queries
• Easily create database queries based on any combination of parameters
to locate samples
• Execute with single mouse click and directly view/report search results
• Gain fast, easy insights into your laboratory

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Summary
• RFT needs preparation and reproducibility
• Automation where possible
• Chromeleon CDS Software provides:
• Predictive Performance
• Improves instrument utilization and uptime  analysis
more likely to complete first time
• ICH Method Validation Templates
• Ensure method is robust and suitable for the intended
analysis  more likely to run first time
• eWorkflows
• Create complete, correct sequence with predefined files
and well-defined structure  correct sequence first time

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Summary
• Sequence Ready Check
• Ensures all sequences are correctly configured and ready
to run first time  sequence will run to completion
• Smart Startup
• Automatically initializes instrument & sets correct initial
conditions  first injection is always good
• System Suitability Tests with Intelligent Run Control
• Check all aspects of analysis including results against
specs and take automated, in-run actions  no OOS
results and sequence completion = all specs passed
• Report Templates with built-in Report Check
• Remove transcription errors and ensure all calculations are
instantly updated and correct  high confidence in results

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Summary – Bringing It All Together
Chromeleon CDS has all the tools to help you
get it right first time every time!

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For more information about Chromeleon 7.2 CDS or
to request a Demo CD, visit:
thermoscientific.com/Chromeleon
Like Charlie Chromeleon on Facebook to follow his travels and
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Thank you for listening