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. Getting 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).
Text of Getting It “Right First Time” Seminar Series – Part 5
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
