©2010 Waters Corporation | COMPANY CONFIDENTIAL
Architecture
Web based licensing
ACQUITY improvements
Fraction Collection
Usability and Workflow
Mass Spectrometry
Method Validation Manager
Automated Software Validation
Designed for the Enterprise
©2010 Waters Corporation | COMPANY CONFIDENTIAL 2
Technology:
— Oracle 11G R2 Database (64 bit)
— Windows 2008 R2 Server Enterprise (64 bit)
— Windows 7 Professional Operating System (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
©2010 Waters Corporation | COMPANY CONFIDENTIAL 3
Operating Systems not supported
— Windows NT
— Windows 2000
— Windows XP 64-bit
— Windows 2000 Server
Installation will not be allowed on these OS’s
Windows Vista 32-bit, Vista 64-bit, Windows 7 32-bit and
Windows Server 2003 are not supported; however, installation will be allowed on these operating systems.
Installation on Oracle < 11.2 will be prevented; higher versions allowed
LAC/E
32 configurations 10 -13 supported
— Config 10 and 11 need additional memory—2 GB minimum
— Config 10 and 11 supported on Windows XP 32 bit only
©2010 Waters Corporation | COMPANY CONFIDENTIAL 4
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 installer
System 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 SystemsQT for Japanese
— Empower 1154 SP ISSP1 for Chinese or Korean
©2010 Waters Corporation | COMPANY CONFIDENTIAL 5
Project restore will be supported for projects backed up in
Millennium
32 version 2.15 or higher.
Push installations
— Cli t ft
— Instrument control software
— Waters is testing with Microsoft PSExec
— Local + Network log file o
Log file name = ‘computer name’ + ‘date/time stamp’ o g unsuccessful g
©2010 Waters Corporation | COMPANY CONFIDENTIAL 6
Waters License Activation Center – Web
— Used to activate and export licenses selected from order number
— User provides contact information
— User selects desired software serial numbers
— License activation file is created for download
— User executes License Wizard to activate license on computer
Splitable user licenses
M lti d t b li
©2010 Waters Corporation | COMPANY CONFIDENTIAL 7
ACQUITY Information
Sample Set Information
Date
Sample Set Name
User Name
System Name
Injection Count
Sample Count
Max Pressure
Max Temperature
Sample Set Complete
Injection information – associated with injections
eCord Name
Serial Number
Injection Count
Summary information
— Injection Count
— Date Of First Injection
— Date Of Last Injection
— Sample Count
— Maximum Pressure
— Maximum Temperature
Information updated after each injection
Requires updated ICS (driver)
©2010 Waters Corporation | COMPANY CONFIDENTIAL 8
ACQUITY Information
eCord data viewed and managed in
— eCord Summary Table
— eCord Sample Sets table
eCords added automatically when data is acquired using system containing eCord
Enumerated custom fields called Column Name and Column
Serial Number (for non-ACQUITY systems)
©2010 Waters Corporation | COMPANY CONFIDENTIAL 9
Run Samples and QuickStart
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
©2010 Waters Corporation | COMPANY CONFIDENTIAL 10
WFC III control in Empower 2
Enhancements in Empower 3
— Fraction annotations on chromatogram
— Fraction table
— Fraction tab in Project window
©2010 Waters Corporation | COMPANY CONFIDENTIAL 11
Preview
Save and Preview
Alter Sample
Run Samples
©2010 Waters Corporation | COMPANY CONFIDENTIAL 12
©2010 Waters Corporation | COMPANY CONFIDENTIAL 13
j acquisition p p
— Allows flexibility in processing
— Allows combination for use of individual injections in MVM
— Allows combination for use in Dissolution/CU multi-phase studies
Privilege called Manage Process Only Sample Set
Fully audit trailed
Creating and editing as in Alter Sample -is similar to altering a
©2010 Waters Corporation | COMPANY CONFIDENTIAL 14
•
•
Imported
•
Copied
P l
©2010 Waters Corporation | COMPANY CONFIDENTIAL 15
Project integrity errors won’t stop batch project backup/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
— Does not pertain to 6-button window
Run Samples Control Panel Position saved as preference
©2010 Waters Corporation | COMPANY CONFIDENTIAL 16
View Message Center for All Users privilege
— Allows granularity to specify users that see all messages or only their own
ApexTrack Use appropriate peak width for USP Plate Count
USP Resolution and Relative Resolution determination
— Values dependant on inflection points Width@Tangent
— k previous versions d h ld h d
— Software will recalculate peak’s inflection points using a peak i t ( t) f th k i t d f th possibly inappropriate peak width in the method
— Affects peaks using PW outside of 2X Auto-PeakWidth range
— No more message regarding “Inappropriate Peak Width”
©2010 Waters Corporation | COMPANY CONFIDENTIAL 17
©2010 Waters Corporation | COMPANY CONFIDENTIAL 18
Allows determination of noise within a blank injection centered on the peak region
Allows user to specify a noise segment based on peak width at half height:
— p g
— EP Half Height Multiplier for Noise Region
— JP Half Height Multiplier for Noise Region
—
©2010 Waters Corporation | COMPANY CONFIDENTIAL 19
MS Ion Ratios + Acceptance
Tolerance
— 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
©2010 Waters Corporation | COMPANY CONFIDENTIAL 20
Open Access, Run Samples, QuickStart, Alter Sample
Specify up to 5 base monoisotopic masses in sample table
(not processing method)
Possible adducts entered in PM
Obtain Yes/No answer as to whether the target mass is present in sample
©2010 Waters Corporation | COMPANY CONFIDENTIAL 21
Masses specified in Run Samples supersede the one in the
©2010 Waters Corporation | COMPANY CONFIDENTIAL 22
Accuracy Total Error
— Sums intermediate precision and bias
— % Total Error
— % Relative Error
— % Relative Error Mean
— Tolerance Interval
— Upper/Lower Limit of
Quantitation
Accuracy Profile Plot
% Relative Error vs. X Value
©2010 Waters Corporation | COMPANY CONFIDENTIAL 23
MVM Linearity of the Method
Linearity of the Response (current) – Response vs.
Linearity of the Method - Calculated value (from linearity of response) vs. Amount/Concentration
Linearity of the Method
Linearity of the Response
©2010 Waters Corporation | COMPANY CONFIDENTIAL 24
Validation Services
Validation: barrier to adopting new software & updates
Leverage ESS Proven record of success in > 40 Empower customers + 10 years validation experience
Automation of existing test execution
— Estimates suggest that automating tests will take half the time for execution
Complementary service to Connections AQT and SystemsQT
©2010 Waters Corporation | COMPANY CONFIDENTIAL 25
Service offering for new chromatographic system qualification tool for system level test
Integrated Empower 3 Software
— Launch SystemsQT Wizard from Run Samples to Qualify
System
Wizard guides user through the system qualification
Each system configuration includes an
Empower project with predefined l t l l ti d t
©2010 Waters Corporation | COMPANY CONFIDENTIAL 26
Supported Configuration y
All ACQUITY Configurations
— uo esce ce etecto ,
ACQUITY Photodiode Array Detector, ACQUITY Tunable UV
Detector, ACQUITY Evaporative Light Scattering Detector,
ACQUITY SQD single quadrupole Mass Detector and ACQUITY
TQD tandem quadrupole Mass Detector
All Alliance 2695/2795 Configurations
— Including the Waters UV/Visible Detectors, Waters PDA Detector,
Waters FLR Detector, Waters RI Detectors, Waters 3100 SQ and
TQD tandem quadrupole Mass Detectors
Modular HPLC Systems
— Including 1515/1525 Pumps, 2707 injector and RI/UV detectors
Agilent LC Configurations
I l di UV DAD RI d FLR D t t
Agilent GC Configurations
7890, 6890, 6850 and G1888 HS
©2010 Waters Corporation | COMPANY CONFIDENTIAL 27
Fusion Method Development
Q
Reduces method development time from weeks to days
Create and builds statistically valid experimental designs
P di i l di i f h d d
Builds robustness in for the long-term viability and transferability of the method
Generates a statistically valid design space
— Characterizes the impact of chromatographic parameters on separation performance
— Eli i t / d th d re-validation re-work
— Aligned with QbD guidelines
I d ffi i d confidence that methods will
Validate and transfer
©2010 Waters Corporation | COMPANY CONFIDENTIAL 28
Fusion Method Development Software
Q
Original Approach
0.070
HPLC
10 columns
Isocratic & gradient conditions
0.040
Gradient slopes
Mobile phase compositions
0.020
0.000
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
Minutes
Fusion with ACQUITY UPLC
®
0.040
Gradient conditions
Gradient slopes
Mobile phase compositions pH
0.010
Pump flow rate
0.005
0.000
-0.005
1.00
1.50
2.00
2.50
3.00
3.50
4.00
Minutes
4.50
5.00
5.50
6.00
6.50
7.00
©2010 Waters Corporation | COMPANY CONFIDENTIAL 29
— Tools for the Chemist o
New Instrument Control o
Usability features o
Option enhancement o
Process only Sample Sets
— Tools for the Lab Managers and Administrators o
Help with Deployment in complex architectures o
Simpler License management o
Easier Global deployment o
Tools to streamline the software validation
ENABLING
INFORMATION
LINKING INSTRUMENTS
IMPROVING WORKFLOW
AND PRODUCTIVITY
©2010 Waters Corporation | COMPANY CONFIDENTIAL 30
©2010 Waters Corporation | COMPANY CONFIDENTIAL 31
©2010 Waters Corporation | COMPANY CONFIDENTIAL 32
