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Empower SystemsQT for Software
This protocol document describes the
process for performing the Installation
Qualification (IQ) and Operational Qualification
(OQ)
R
for
Waters? Empower
○
SystemsQT?
for Software, with or without Method
Validation Manager (MVM) software.
Evaluate before qualification begins
The owner's management must review this
protocol, the Empower SystemsQT for Software
release notes (part number 716003298),
the
Waters Qualification
Overview
(part number 715511111), and
Empower 3 software release notes:
?
?
Empower 3 (base) Release Notes (part
number 715002704)
Service Release 1
Release Notes (part number 716003450)
To perform the qualification, you must
be running Empower 3 Feature Release 1, minimum.
?
?
?
Feature Release
1 Release Notes (part number 716003561)
Feature Release 2 Release Notes (part
number 716003923)
Feature Release 3
Release Notes (part number 716004689)
Identify the scope:
?
?
Personal, Workgroup, or Enterprise
Considerations
for
IQ or OQ
execution:
Execution for
the
Citrix? server requires it to be listed as a node.
If the Citrix server is not listed as a node,
login to the Citrix
server and launch
Empower. In Nodes, create a new node using the
exact name of the Citrix server.
?
?
?
Ensure computer
connection to a printer, however each node does
not require printer access.
Enable the
Run Empower SQT privilege for your User Type.
If intending to use Electronic
Signatures, perform the following:
o
Enable the Sign Off Results 1 for your User Type.
o Check the Result Sign Off tab in
System Policies for Valid Sign Off 1 Reasons.
◎ Determine if Default Strings for
Result Signoff i Meanings and Result Sign off 2
Meanings can be created. Create
、
'Pass
〃
and
''Fail
In the Qualification
Overview document, ensure that these forms are
completed:
?
?
WClt?rS
THE
SCIE^NC? OF
'Empower,
Millennium, NuGenesis, ''The Science of What's
.Possible
and ApexTrack, LAC/E, and
SystemsQT are trademarks of Waters Corporation.
Citrix is a registered trademark of
Citrix Systems, Inc. AH other trademarks are the
sole property of their respective owners.
Copyright ? 2016 .Waters Corporation
March
2016
Qualification
Approval
Identification of Performers
and Reviewers
715G05185, Revision A
Overview
The Empower
SystemsQT for Software is specific to the Empower
3 FR1 and above releases. The Empower SystemsQT
uses a wizard
to run the software IQ
and OQ. The reports can be signed off
electronically or printed. Reports that display
the method parameters
used may contain
blank fields because the parameters may not be
enabled or populated in the method.
The
data set used for IQ is a blank injection and is
used to create the IQ report and allows for
electronic signature. The IQ data set
was collected for Empower 3 FR3.
The data set used for internal standard
calculations is identical to that used in Empower
2154, Empower 1154, or
Millennium
32
?
v3.2, v3.05.01, or v3.05.
The data set used for external standard
calculations is identical to that used in Empower
2154, Empower 1154, or
Millennium
32
v4.0
or v3.2.
The data set used
for the method validation manager is identical to
that used in Empower 2154 FR 3.
You
need not enable ApexTrack? integration if your
organization uses traditional
integration.
Installation
qualification (IQ)
The IQ represents
the installation qualification process for a
Waters Empower 3 Personal, Workgroup, Enterprise,
or LAC/E32?
module software system
consisting of software and associated hardware
components.
The purpose of the IQ
portion of the qualification is to confirm these
conditions:
?
?
?
?
?
?
?
Personal, Workgroup, Enterprise, and/or
LAC/E
32
module software
components are properly installed.
Empower 3 software is properly
installed.
Empower 3 files you
installed on the system are not corrupted and
remain identical to the flies shipped from Waters.
Any Empower 3 software options are
properly installed.
The name of the
operating system, build number, and all service
packs apply.
The total number of
Empower 3 named user licenses and system licenses
for Workgroup and Enterprise.
Any
Empower 3 service packs are properly installed and
verified.
Software file verification
During installation of the Empower 3
software, the software automatically runs a file
verification utility, which verifies that the disk
files shipped from Waters were not
corrupted during Installation. The file used for
the comparison is in
.
The
file verification focuses on these file
attributes:
?
?
?
Cyclic Redundancy Checksum (CRC)
File size
File date and time
stamp
If the file verification utility
detects a change in any file, the installation is
aborted. You can rerun the utility anytime, to
requaiify
the installation.
Rule:
The software does not
overwrite the original file each time you run the
Verify Files utility. Instead, each
subsequent file name is annotated with
the date and time: for example,
EmpowerSCRIPTChecksum_il.01.2010_.
Operational qualification (OQ) for
Empower SystemsQT for
Software only
Evaluate and determine if traditional
integration or ApexTrack integration will be used
when executing the OQ.
Restore the
appropriate projects based upon the integration
chosen:
?
?
Traditional
Integration
一
Restore the
Valid_OQl project
ApexTrack Integration
- Restore the Valid_OQl and Valid_OQApex projects
Ensure all appropriate projects are
restored. If all of the projects (Valid_OQl,
Valid_OQApex, and Valid_OQMVM) are not restored
the following message will appear when
making requests from the SQT wizard:
It
is not required to restore all the projects, only
those appropriate. If the appropriate projects are
restored, click
、
'No
〃
and continue.
The
projects provided by Waters are limited to
verifying and documenting the ability of Empower 3
software to perform these
tasks:
?
?
?
?
?
?
?
Restore
projects
Process standards
Process unknowns
Perform
peak integration
Perform quantification
Perform calibration
Generate
a printed report or save a result to the database
Notes:
?
When the
ApexTrack Integration option is enabled and both
the Vaiid_OQl and
Valid
—
OQApex projects are
restored, the
result sets for the
Internal Std Sample Set and External Std Sample
Set will be available in both projects when an OQ
request
is initiated.
?
The reports
contain an ''Integration
Algorithm
Operational qualification for
Empower SystemsQT for
Software with
Method Validation Manager
If you
activated the Empower SystemsQT for Software MVM
qualification, the OQ uses the Valid_OQMVM
project.
The Valid_OQMVM project is
provided by Waters and limited to verifying and
documenting the ability of the Empower 3 Method
Validation Manager to perform these
tasks:
?
Restoring a validation working type
project.
?
Generating statistical validation
results for all validation tests.
?
Ensuring the
correct value is generated during validation
processing.
?
Ensure you restore the appropriate
project folders for Empower 3 Feature Release 3.
The report includes method validation
results and protocol for these method validation
tests:
?
Linearity
?
Linearity comparison
?
LDL/LQL
?
Specificity
?
Accuracy
?
Repeatability
?
Reproducibility
?
Intermediate
precision
?
Intermediate precision DOE
?
Robustness
?
Stability
?
Filter
validation
?
System precision
Node
Properties
The SQT license enables
additional tabs in the node properties: IQ Info
and IQ/OQ.
1.
In
Configuration Manager, select Nodes and then
select a node to update its properties.
2.
Right-click
properties.
3.
Select the IQ Info tab.
?
Identify the
computer components associated with this software
IQ in the spaces provided.
?
When you complete the Computer
Components form, compare the information entered
on it with the purchase order for the
Empower 3 software system.
?
When you
install software as part of a reloading operation
or software support plan upgrade, the purchase
order is
sometimes unavailable. In such
a case, type ''RELOAD
Component for that
client.
4.
Identify the documentation information
required for qualification. When you complete the
documentation Information,
identify
each document as follows:
?
If the document was received, select
Yes.
?
If the
document was not received, select No.
?
If the document
has a revision, enter the revision.
?
If the document
is missing or not applicable, enter that
information in the comments.
5.
Identify the
components and peripherals of the Empower 3 system
associated with this software IQ.
?
When you
complete the Configuring the Computer and
Peripherals section, select either ''Installed
、
'N/A
corresponding to
each device you install.
?
If any comments apply to the
installation, enter them in the comments section.
Note: If the Empower 3 system was
purchased from Waters, you need not verify the
configuration. Instead, in the configuring
components and peripherals section,
certify that the computer was configured at the
factory by selecting Yes.
6.
Click OK.
Running the
Empower SystemsQT for Software
To run
the Empower SystemsQT for Software, perform these
tasks:
1.
2.
a.
b.
Log in to
Empower, using the Pro interface, as a designated
user with a full name. Do not log in as one of the
default users.
Before the qualification
begins, ensure these conditions are met:
The owner's management reviewed the
Qualification Overview,
this
protocol, and any applicable release notes.
The Qualification Protocol Approval
Form 1-1 and the Identifying Performers and
Reviewers Form 1-2 (both available m the
Qualification Overview
document) are completed and signed.
3.
From the
Empower Pro window, click Configure System, and
then select Projects.
Requirements:
?
To run the
qualification, you must activate the Empower SQT
for Software and the Empower SQT for Software MVM
options,
as applicable.
?
4.
5.
6.
7.
To run the
Empower SystemsQT you must have enabled the Run
Empower SQT privilege for your User Type.
Insert the Empower SystemsQT for
Software DVD into the DVD drive.
From
the menu bar, select File > Restore Project.
Browse to the Empower SystemsQT for
Software DVD, and select the appropriate Empower
version and language folder.
Depending
on the type of integration algorithm to be used in
Empower, restore the following projects:
?
?
Valid
一
OQi project
for IQ and OQ when using traditional integration.
Valid
—
OQl project
and Valjd_OQApex project for IQ and OQ when using
ApexTrack integration.
?
8.
9.
Valid_OQMVM project (regardless of the
integration algorithm used) if using the Method
Validation Manager.
In Configuration
Manager, view the properties of the restored
project(s).
Set the project access to
allow for ail required individuals to access the
projects. If using owner and group access, ensure
that
the group access includes both the
group in which you are a member and the groups of
all other required indMduals.
Requirement:
The specific
projects names are required by the wizard to run
the SQT. If you change the name of a project
before initiating the SQT request, the
request will not be completed.
10.
In
Configuration Manager, select Tools > EmpowerSQT.
11.
In the
service password dialog box, enter the case-
sensitive password, and click OK.
Empower SQT
WWMWi
Result:
When you correctly
enter the case-sensitive password, and click OK,
the Introduction wizard page appears.
12.
Click Next.
13.
For Empower 3
FR3 users, select the node on which you would like
to perform the automated qualification. This can
be a
workstation, client, Citrix
server, or LAC/E
32
.
Notes:
?
To deselect all displayed nodes, clear
the checkmark for the first node and then press
Ctrl+D to copy the clearing down for
all displayed nodes.
?
If the Citrix
server is not listed as a node and is required,
login to the Citrix server and launch Empower. In
Nodes, create a new
node using the
exact name of the Citrix server.
?
Ensure you
select the appropriate qualification request:
IQ: To perform the Empower software
installation qualification on that node.
OQ: To perform the Empower software
operational qualification on that node.
OQ MVM: To perform the Empower software
operational qualification for Method Validation
Manager on that node.
14.
Click Start,
This action cannot be undone and initiates the
qualification requests selected.
Result:
Initiation of the
qualification requests cause the Date of Execution
field in the node properties to be automatically
populated for the qualification
requests selected. TKe Date of Execution cannot be
manually modified, entered, or deleted.
15.
The Complete
wizard page appears. Click Close if the
qualification requests are complete. This will
exit the SQT wizard. Click
New Request
to resubmit, update, or create a new qualification
request.
IQ Report
Perform
this procedure:
1.
2.
From Configuration Manager, open the
Va!id_OQl project.
Select the Results
Sets tab.
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