1 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

2 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

3 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 thats 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)

4 How to Get It Right the First Time?

5 How to Get It Right The First Time? Reasons things dont 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, arent 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

6 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

7 Chromeleon CDS Tools for RFT Analysis

8 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

9 Report Designer

10 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

11 Chromeleon CDS Report Designer

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

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

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

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

16 Chromeleon Report Templates and can even include custom equations

17 Chromeleon Report Templates to create the report you need.

18 Example 1: Report in Microsoft Excel

19 Example 1: Report in Chromeleon CDS

20 Example 2: Calculations in SOP

21 Example 2: Calculations in Chromeleon CDS

22 Example 3: Calculations in Pharmacopeia Content Uniformity Dissolution

23 Example 3: Calculations in Chromeleon CDS Content Uniformity Dissolution

24 Report Check

25 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

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

27 Chromeleon Reports for Data Mining

28 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

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

30 Data Mining Injection Query Report

31 Data Mining Instrument Usage Statistics

32 Live Demo Lets have a look at the reports, Report Check and Injection Queries in action

33 Summary

34 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 doesnt 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

35 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

36 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

37 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

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

39 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