Empower 3 Manual-1

8/20/2019 Empower 3 Manual-1

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Empower 3 SoftwareEmpower 3 Software

September 2010September 2010

©2010 Waters Corporation | COMPANY CONFIDENTIAL



Em ower 3Em ower 3

Web based licensingACQUITY improvements

Fraction Collection

Usability and Workflow

Method Validation Manager

Automated Software Validation

Designed for the Enterprise

©2010 Waters Corporation | COMPANY CONFIDENTIAL 2



Em ower 3 ArchitectureEm ower 3 Architecture

— Oracle 11G R2 Database (64 bit)— Windows 2008 R2 Server Enterprise (64 bit)— Windows 7 Professional O eratin S stem 64 bit — Windows XP Operating System (32 bit) (clients and LAC/Es)— Citrix XenApp Server 6.0 running on Windows Server 2008 R2

Enterprise, 64-bit,

Empower 3 is 32-bit app running in a 64-bit environment




InstallationInstallationOperating Systems not supported

— Windows NT

— Windows 2000— Windows XP 64-bit— .

Installation will not be allowed on these OS’s

Windows Vista 32-bit, Vista 64-bit, Windows 7 32-bit andWindows Server 2003 are not supported; however,installation will be allowed on these operating systems.Installation on Oracle < 11.2 will be prevented; higherversions allowedLAC/E 32 configurations 10 -13 supported

— —


— Config 10 and 11 supported on Windows XP 32 bit only



Installation from Previous VersionsInstallation from Previous Versions

Installation includes ability to perform a system object

software.Server installation allows you to bring the exported

.— no system object export or import offered as part of the

personal installerSystem object export supported from the following versions:

— Empower 2154 FR 3— Empower 2154 FR 4— Empower 2154 FR 5— Empower 1154 SP M for English—


— Empower 1154 SP ISSP1 for Chinese or Korean



InstallationInstallation

Millennium32

version 2.15 or higher.Push installations

— en so ware— Instrument control software

— Waters is testing with Microsoft PSExec— Local + Network log file

o Log file name = ‘computer name’ + ‘date/time stamp’ o ‘Err’ is indicated at beginning of log file name if installation

unsuccessful






AC UITYAC UITY eCordeCord InformationInformationSummary information

— Injection Count

Sample Set InformationDate

— Date Of First Injection— Date Of Last Injection— Sample Count

Sample Set NameUser Name

— Maximum Pressure— Maximum Temperature

Information updated after each

Injection Count

Sample Count injection

Requires updated ICS (driver)

Max TemperatureSample Set Complete

Injection information –associated with injections

eCord Name


Serial Number

Injection Count



AC UITYAC UITY eCordeCord InformationInformationeCord data viewed and managed in

— eCord Summary Table— eCord Sample Sets table

eCords added automatically when data is acquired usingsystem containing eCord

Enumerated custom fields called Column Name and ColumnSerial Number (for non-ACQUITY systems)




AC UITY In ection ModesAC UITY In ection Modes

Full Loop Mode— Injection volume field automatically filled in with the loop

— Field not editable

Partial Loop Mode / with Needle Overfill— Injection volume must be within the valid injectable volume

range defined by the instrument— Editable field




WFCIIIWFCIIIWFC III control in Empower 2

— Fraction annotations on chromatogram— Fraction table

—




UsabilitUsabilit

Navigate from Review to….Navigate from Review to….

Preview

Save and Preview

Alter Sample

Run Samples


Navigate tree using arrow keysNavigate tree using arrow keys





Process Onl Sam le SetsProcess Onl Sam le Sets

Allows combinin dis arate in ections into a sam le set ost-

acquisition— Allows flexibility in processing— — Allows combination for use in Dissolution/CU multi-phase studies

Privilege called Manage Process Only Sample SetFully audit trailed

Creating and editing as in Alter Sample -is similar to altering are ular sam le set.




Process Onl Sam le SetsProcess Onl Sam le Sets

• Imported• Copied


• rocess on y



UsabilitUsabilit

Project integrity errors won’t stop batch projectbackup/restore

— Log file is generated to document errors— Time zone and database update request also won’t stop backup

Multiple application windows locked due to timeout— Unlock once to unlock all— -

Run Samples Control Panel Position saved as preference




UsabilitUsabilit

— Allows granularity to specify users that see all messages oronly their own

-USP Resolution and Relative Resolution determination

— Values dependant on inflection points Width@Tangent— Incorrect pea wi t parameter cou over smoot ata in

previous versions— Software will recalculate peak’s inflection points using a peak

w a s appropr a e correc or e pea ns ea o epossibly inappropriate peak width in the method— Affects peaks using PW outside of 2X Auto-PeakWidth range


— No more message regarding “Inappropriate Peak Width”



EP/JP/USP Si nal to NoiseEP/JP/USP Si nal to Noise




EP/JP/USP Si nal to NoiseEP/JP/USP Si nal to NoiseAllows determination of noise within a blank injectioncentered on the peak region

Allows user to specify a noise segment based on peak widthat half height:

— USP Half Hei ht Multi lier for Noise Re ion— EP Half Height Multiplier for Noise Region— JP Half Height Multiplier for Noise Region—




MS Ion Ratios + AcceptanceMS Ion Ratios + Acceptance

ToleranceTolerance— For defensible compound confirmation— Area or Height ratio of 1 0 Channel : 2 0 Channel (1 – 4) in same injection— Acceptance tolerance on result as compared to a reference injection— Failed values are faulted




MS Tar et MassesMS Tar et MassesOpen Access, Run Samples, QuickStart, Alter Sample

Specify up to 5 base monoisotopic masses in sample table(not processing method)Possible adducts entered in PMObtain Yes No answer as towhether the target mass ispresent in sample




MS Tar et MassesMS Tar et MassesMasses specified in Run Samples supersede the one in the




MVM : SFSTP CalculationsMVM : SFSTP Calculations

Accuracy Profile PlotAccuracy Total Error

% Relative Error vs. X Value— Sums intermediate precisionand bias

— % Total Error— % Relative Error— % Relative Error Mean— Tolerance Interval— Upper/Lower Limit of

Quantitation




MVMMVM –– Linearit of the MethodLinearit of the MethodLinearity of the Response (current) – Response vs.

Linearity of the Method - Calculated value (from linearity ofresponse) vs. Amount/Concentration

Linearity of the Method

Linearity of the Response




ValidationValidation ServicesServices

Validation: barrier to adopting new software & updates

Leverage ESS Proven record of success in > 40 Empowercustomers + 10 years validation experience

— Estimates suggest that automating tests will take half the time

for execution

and SystemsQT




S stems TS stems T

Service offering for new chromatographic systemqualification tool for system level test

Integrated Empower 3 Software—

System

Wizard guides user through the system qualification

Each system configuration includes anEmpower project with predefined

samp e se s, ca cu a ons an repor s




Supported ConfigurationSupported Configuration

with S stems Twith S stems TAll ACQUITY Configurations

— All modules includin the AC UITY Fluorescence DetectorACQUITY Photodiode Array Detector, ACQUITY Tunable UVDetector, ACQUITY Evaporative Light Scattering Detector,ACQUITY SQD single quadrupole Mass Detector and ACQUITYTQD tandem quadrupole Mass Detector

All Alliance 2695/2795 Configurations— Includin the Waters UV Visible Detectors Waters PDA Detector

Waters FLR Detector, Waters RI Detectors, Waters 3100 SQ andTQD tandem quadrupole Mass Detectors

Modular HPLC S stems — Including 1515/1525 Pumps, 2707 injector and RI/UV detectors

Agilent LC Configurations


nc u ng , , an e ec ors

Agilent GC Configurations7890, 6890, 6850 and G1888 HS



Fusion Method DevelopmentFusion Method DevelopmentSoftware with AC UITY UPLCSoftware with AC UITY UPLC

Reduces method development time from weeks to daysCreate and builds statistically valid experimental designs

re ct opt ma con t ons or t e process un er stu y

Builds robustness in for the long-term viability and transferabilityof the methodGenerates a statistically valid design space

— Characterizes the impact of chromatographic parameters on separation

performance — m na es re uces me o

re-validation re-work— Aligned with QbD guidelines

ncrease e c ency anconfidence that methods willValidate and transfer




Fusion Method Development SoftwareFusion Method Development Softwarewith AC UITY UPLCwith AC UITY UPLC

Original Approach0.060

0.070

HPLC

A U

0.020

0.030

0.040

0.05010 columnsIsocratic & gradient conditions

Gradient slopesMobile phase compositions

0.000

0.010

Minutes

1.00 2.00 3.00 4.00 5.00 6.00 7.00 8.00 9.00 10.00 11.00 12.00 13.00 14.00 15.00 16.00 17.00 18.00 19.00 20.00

0.025

0.030

0.035

0.040

A P I 1

- 5 . 1 8

A P I 2

- 5 . 6 6 1

ACQUITY UPLC3 columns

Gradient conditions

A U

0.000

0.005

0.010

0.015

0.020

1 2 9 2 . 8 3 3

. 2 8 6 7 3 3

4 . 1 2 5

4 . 3 1 0

. 4 8 2 . 5 9 4

I m p

A - 4 .

7 3 8

p B

- 4 . 9 4 7

s t p e a k - 6 .

1 2 8

Mobile phase compositionspH

Pump flow rate


-0.005

Minutes

1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00

1 . 5 2 . 3 . 4 . I L



Em ower 3 SoftwareEm ower 3 Software

— Tools for the Chemisto New Instrument Controlo Usability featureso Option enhancemento Process only Sample Sets

— Tools for the Lab Managers and Administrators

o Help with Deployment in complex architectures

ENABLINGINFORMATION

o Simpler License managemento Easier Global deploymento Tools to streamline the software validation IMPROVING WORKFLOW

AND PRODUCTIVITY

LINKING INSTRUMENTS




DiscussionDiscussion





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Empower 3 Manual-1

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