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1The world leader in serving science
Darren Barrington-LightProduct 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
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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!
eWorkflows
SST & IRCSmart Startup
Ready Check
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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 get important updates on chromatography software!
facebook.com/CharlieLovesChromatography
Thank you for listening