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Corporate Template for External Use

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

The world leader in serving science

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1

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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3

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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Lack of preparation

“To fail to prepare, is to prepare to fail” (Anonymous)

Rushing the task

Often leads to a lack of attention to detail

Lack of attention

Multi-tasking can cost you time

Leaving things undone

Trying to pick up where you (or someone else) left off can create errors

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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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Very often, in order to meet reporting requirements, reports need to be customized. In many chromatography data systems this is a tedious and time consuming job, as the reporting options within the software can be limited, especially when additional calculations are required.

To avoid this, many customers transfer the data obtained from the CDS to en external spreadsheet, for example Microsoft Excel. This is a time consuming process, and when transferring the data errors can be made. In addition, when making changes to the chromatography data, the spreadsheets are not dynamically updated. Also it is not possible to have change control in the spreadsheet.

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Chromeleon CDS – Report Designer

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Chromeleon CDS provides a flexible spreadsheet-based report designer. User-defined report templates can be easily created and modified to meet reporting requirements with full traceability and without the need to export data to external spreadsheets.

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Chromeleon Report Templates…

… can have as many worksheets as required

1

2

Many

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The Chromeleon Report Template can be very simple or as complex as required, containing only 1 or 2 sheets, or as many as necessary.

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Chromeleon Report Templates…

… can contain text and variables

Text

Variables

Variables

Text

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The report cells can contain plain text, or report variables to display dynamic content.

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Chromeleon Report Templates…

… can include result tables

Peak Tables

Summary Tables

Audit Trails

and many others!

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The report templates can also contain various types of report tables, from which you can see some examples here.

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Chromeleon Report Templates…

… can include various plot types

Chromatogram

Calibration

UV Spectrum

Mass Spectrum

Injection Rack

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And of course various plots can be added as well.

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Chromeleon Report Templates…

… and can even include custom equations…

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On top of that also custom calculations can be added…..

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Chromeleon Report Templates…

… to create the report you need.

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When combining all of this together you can create exactly 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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When custom reports are created, of course this needs to be checked for errors, and maybe even validated. Especially with extensive customized reports this can be a time consuming and tedious job.

Chromeleon CDS provides a built-in error check for report templates. This automatically checks every entry in the report, using a simple interface.

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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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When checking the report you get an overview of all errors. When selecting one, this automatically displays the location and selects it in the report. Additionally the errors can immediately be fixed.

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Chromeleon Reports for Data Mining

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Data Mining –

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