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,
Thermo Scientific Dionex Chromeleon Chromatography
Data System (CDS) Software,
Thermo Fisher Scientific
March 18, 2014
Getting It “Right First Time” Seminar
Series – Part 1
Right First Time, Every Time
Part #: 71039_E 03/14S

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Agenda
• Introduction
• How to get it right the first time?
• How can your CDS help?
• Thermo Scientific™ Dionex™ Chromeleon™
Chromatography Data System (CDS) Software tools
for RFT analysis
• 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
• 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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Introduction
• In laboratories, delivering an analytical result that’s “right first
time” (RFT) is the answer
• No reprocessing data
• No re-running injections
• No out of specification (OOS) results
• No reporting or calculation errors
• Getting RFT analysis automatically gives:
 High quality of results
 High confidence in results
 Lower cost of analysis
 Improved lab efficiency
 Faster release to market
 Faster 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?
• What do you need for RFT analysis in a laboratory?
• Robust and reliable instrumentation
• Robust, reproducible, and reliable methodology
• Highly trained, experienced operators?
• Preparation
• Documentation
• Qualification
• Training
• Reproducibility
• Removing the “human error” factor – automation

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How to Get It Right The First Time?
• Instrumentation
• Qualification
• Servicing and wear part monitoring – maximize uptime.
• Methodology
• Standard operating procedures
• Document describing all steps and activities of a procedure that can be followed
to guarantee a specific outcome
• i.e. ensure an analysis is always done the same way, no matter who performs it
• “Streamlining Routine Chromatography Analyses Using eWorkflows™” webinar
• Validated analysis methods
• Demonstrate that an analytical procedure is suitable for its intended purpose
• i.e. it gives accurate results, reliably and under different circumstances
• Operators
• Training – How to get inexperienced users as good as experienced?

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How Can Your CDS Help?
• Guy scratching head looking at PC?

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How Can Your CDS Help?
• 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 Tests with Intelligent Run Control
• Spreadsheet-based Report Designer with integral Report Check
• Operators
• All the above combine to ensure ANY operator can achieve RFT
analysis

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Instrumentation – Predictive Performance

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Instrumentation – Predictive Performance
• Combined with Thermo Scientific™ Dionex™ UltiMate™
3000 LC, or some of the Thermo Scientific™ Dionex™ ICS
Systems, Chromeleon CDS software provides several
counters to monitor system performance:
• Some counters are expressed as dates (Service)
• Some counters are expressed as numbers (Wellness)
• For these counters it is possible to set:
• An Interval and a Warning Period (Service)
• A Limit and a Warning Limit (Wellness)
• Limits checked before running samples and appropriate
warning messages provided to user
• The counter information is stored in module, not in software

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Instrumentation – Predictive Performance
• Predictive performance for Service and Wellness features are
accessible through module ePanels

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Instrumentation – Predictive Performance – Service
• Last service date, service
interval and warning period
are entered
• When reaching warning
period, warning is written in
audit trail and color changes
to yellow
• When exceeding service
interval, warning is written in
audit trail and color changes
to orange

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Instrumentation – Predictive Performance – Wellness
• Wellness parameters work
similar to service parameters
• For the wellness parameters
it is possible to set limits and
warning limits
• All limits are predefined by
module designers, and
default values regularly
updated based on field input

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Instrumentation - Predictive Performance - Qualification
• Keeps track of the qualification status of module
• For each module administrators can define
• Qualification interval
• Warning period
• Grace period
• Administrators can ensure users cannot work with modules
after dates are exceeded
• The counters are stored in the modules

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Benefits of Predictive Performance
• Instrument notifies you of impending service/qualification
• Allows you to schedule workload more effectively
• Improves instrument utilization
• Instrument notifies you of potential wear part failure
• Allows you to schedule instrument maintenance at most convenient time
• Improves instrument uptime
• Prevents you from working with “out of qualification” system
• Enforces regulatory compliance
• Information is stored in instrument firmware
• Ensures data is recorded and maintained at all times, even if module is
moved/exchanged

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Methodology – Validated Methods

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Methodology – Validated Methods
• The objective of validation of an analytical procedure is to
demonstrate that it is suitable for its intended purpose,
i.e. it gives accurate results, reliably and under different conditions
• Different analysts, instruments, columns, or consumables
• Variations in flow, inject volume, mobile phase composition
• It also tests scope of the method
• Concentration range
• Most pharma laboratories and pharmacopeias have
standardized on ICH approach
INTERNATIONAL CONFERENCE ON HARMONISATION OF
TECHNICAL REQUIREMENTS FOR REGISTRATION OF
PHARMACEUTICALS FOR HUMAN USE

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• ICH specifies 8 different tests and when to perform:
• Specificity
• Accuracy
• Precision
• Repeatability
• Intermediate Precision
• Reproducibility
• Detection Limit
• Quantitation Limit
• Linearity
• Range
• Robustness
Methodology – Validated Methods

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• Ensure robustness before you waste time validating!
• How long to validate an HPLC external standard assay
method… about 8 – 12 man days
• Creating the final report can take several hours
• Can be difficult to consolidate data
• Often need external spreadsheets
• Lots of opportunities for errors to occur
Methodology – Validated Methods

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Chromeleon CDS Extension Pack – ICH Templates
• Provide structured approach to method validation
• Not designed to create instrument methods or experimental
design matrices (e.g. for robustness)
• Calculate all results and compare against specification
• Immediately notify you of failed tests
• Allow you to create your final validation report in a couple of
minutes providing significant productivity gains
Methodology – Validated Methods

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ICH Method Validation Templates – Live Demo
• Let’s have a look at how the Chromeleon CDS Extension
Pack performs ICH Method Validation…

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• eWorkflows
• Create complete, correct sequence with predefined files and well-defined
structure
• Sequence Ready Check
• Ensures sequences are correctly configured and ready to run
• Smart Startup
• Automatically initializes instrument & sets correct initial conditions
• System Suitability Tests with Intelligent Run Control
• Take automated, in-sequence pass and/or fail actions based on actual
chromatographic results
• Spreadsheet-based Report Designer with integral Report
Check
• Automatically checks every entry in entire report and provides simple
interface to easily correct any errors
Methodology

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Summary

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Summary
• RFT needs preparation and reproducibility
• Automation where possible
• Chromeleon CDS Software
• Predictive Performance:
• Allows you to schedule workload more effectively and instrument maintenance
at most convenient time
• Improves instrument utilization and uptime
• Enforces regulatory compliance
• Chromeleon CDS Extension Pack:
• Complete data acquisition, calculation, plotting and result reporting using only
Chromeleon CDS
• Immediate review of all results after run/sequence is complete
• Significant productivity gains achieved – saving time and money
• No additional cost for users running Chromeleon CDS software

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• Discover more Chromeleon CDS tools to ensure you get
“right first time, every time” analysis
Next Time….

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Thank You!
Any Questions?