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

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 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)

4

How to Get It Right the First Time?

5

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

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

• Let’s 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 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”

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!

eWorkflows

SST & IRCSmart Startup

Ready Check

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