CESI 8000 Plus High Performance
Separation-ESI Module
System Administration Guide

RUO-IDV-05-3898-D

September 2022

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Contents

1 Overview.................................................................................................................................... 532 Karat Software System Administration Features................................................................. 6
System Activity Log..............................................................................................................6
Audit Trails........................................................................................................................... 6
User Categories........................................................................................................................ 7
System Administrator........................................................................................................... 7
Instrument Administrator...................................................................................................... 8
Users....................................................................................................................................8
Projects................................................................................................................................... 10
Instruments............................................................................................................................. 10
System Administration in the CESI 8000 Plus Software......................................................... 11
2 Software Configuration.......................................................................................................... 12
Activate the System Administration Mode...............................................................................13
Add Users............................................................................................................................... 14
Add System Administrators.....................................................................................................19
Add Projects............................................................................................................................20
Add an Instrument...................................................................................................................23
Configure Electronic Signatures..............................................................................................23
Configure the 32 Karat Software ............................................................................................25
Instrument Logon.................................................................................................................... 27
3 Manage Access to the Software............................................................................................ 28
Manage Projects Using the Project Wizard.............................................................................28
Assign Users to a Project........................................................................................................29
Manage Instrument Access with the Instrument Wizard......................................................... 30
Change Project Settings......................................................................................................... 31
Remove Projects.....................................................................................................................34
4 Additional Features................................................................................................................ 35
The Options Dialog................................................................................................................. 35
Workstation Tab................................................................................................................. 35
Set General Options................................................................................................................36
System Administration Report Utility.......................................................................................39
Create System Administration Report................................................................................40
View the System Activity Log.................................................................................................. 40
Configure Email Notifications.................................................................................................. 44
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5 Example Administration Setup..............................................................................................47
Laboratory Personnel..............................................................................................................47
Process Completion........................................................................................................... 49
6 Worksheets..............................................................................................................................50
Contact Us.................................................................................................................................. 54
Customer Training...................................................................................................................54
Online Learning Center...........................................................................................................54
Purchase Supplies and Reagents...........................................................................................54
SCIEX Support........................................................................................................................54
CyberSecurity..........................................................................................................................54
Documentation........................................................................................................................54

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Overview

1

Overview

Note: For regulatory and safety information for the capillary electrophoresis system, refer to the
document: Safety Notices, System Overview, or Operator Guide.
This guide describes how to configure the 32 Karat software. The system administration featureslets system administrators manage users, projects, and instruments. System administrators canalso configure requirements for audit trails and electronic signatures.
In the 32 Karat software, an instrument is a software representation of a configuration of a
CESI 8000 Plus system. It includes the detector, the tray configuration, and whether options for
system suitability, Caesar integration, and qualitative analysis are available. If more than one
detector is available, then we recommend creating at least one instrument for each detector.
After the software is installed, many of the security features available are enabled, whichfacilitates the installation of a secure environment and provide a project-centered structure.
The 32 Karat software provides a secure user environment, which supports the 21 CFR Part 11
compliance for the creation of electronic records, with the implementation of:• Controlled access to functionality through customizable roles.
• Controlled access to project data on a role-by-role or group basis.
• Audit trails for instrument operation, maintenance, data acquisition, data review, and report
generation.
• Electronic signatures that use a combination of user ID and password.
The security of the system is closely linked to the security of the operating system being used.
The security features of the 32 Karat software have been designed to facilitate compliance. This
document does not provide all of the information required for compliance with this or any otherregulation. Using this or any other software product is not sufficient to assure compliance. The
regulatory department of the organization can provide specific information about the policies andprocedures that must be followed to be in compliance. Become familiar with the appropriate
rules and regulations before configuring the security features of the 32 Karat software. The
organization is ultimately responsible for regulatory compliance.
All system administration functions are accessed from the 32 Karat Software Enterprise window.
Tip! If the left pane is not visible in the Enterprise window, then click View > Hierarchy Pane.

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Overview
Figure 1-1 32 Karat Software

32 Karat Software System Administration
FeaturesThis section describes the system administration features in the 32 Karat software.

System Activity Log
The System Activity log is turned off by default and must be enabled by the systemadministrator. Refer to the section: Set General Options. This log includes all of the activity
performed in the Enterprise window, such as system administration changes and instrument
configurations.
Over time, the System Activity Log can become quite large. The software lets the user archive
the log and remove the original file. Use the Log Viewer application to view the archived data.
After a log is archived, the new System Activity Log indicates the date and location of the archive
file. Refer to the section: View the System Activity Log.

Audit Trails
The Audit Trails track the history of data files and method files. The Data file audit trail isalways active. Method file audit trail must be activated, but can be used in either administrator
mode or standard mode.
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Overview
Data File Audit Trail
A Data file audit trail trail records any process done to the data file after acquisition, such as
when the data file is opened, analyzed, or signed off on with an electronic signature. These
result sections might be different depending on the method used for the analysis. The Data
file audit trail tracks these changes, as well as recording when the file was accessed, and bywhom. A Data file audit trail stays with the data file even if the data file is moved to a different
folder or renamed.
Method File Audit Trail
A Method file audit trail, when active, records all of the edits made to a method file. Thechanges that were made will be recorded, along with the user ID and the time that the change
occurred. Optionally, the user might be prompted to give a reason for the change. The Method
file audit trail might be activated globally or for individual methods. After it is activated for amethod, it cannot be turned off. If a method is saved with a new name, then a new Method file
audit trail is created with the new method, and the old Method file audit trail stays with theoriginal method.
Sequence Audit Trail
A Sequence audit trail, when active, records all of the changes made to a sequence file,along with the ID for the user who made the change, and the time that the change was made.
Optionally, the user might be prompted to give a reason for the change. The Sequence audit
trail might be activated globally or for individual methods. After it is activated for a sequence,
it cannot be turned off. If a sequence is saved with a new name, then a new Sequence audit
trail is created with the new sequence, and the old Sequence audit trail stays with the original
sequence.

User Categories
The 32 Karat software recognizes three classes of users: system administrators, instrument
administrators, and general users. There might be more than one user of each type, and any
individual can serve in more than one role. The user is limited to the specific instruments
and projects as specified by the administration policies set by the instrument and systemadministrator.

System Administrator
The system administrator can use all of the functions in the Enterprise screen of the software.
If the system administrator does not have instrument administrator privileges, then they are
not able to access the instrument configuration screen, which is opened by right-clicking on an
instrument icon and then clicking Configure. The also can perform the following
The system administrator can use all functions in the software, as well as do the following:• Enable logon
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Overview• Manage project settings• Add or remove user access to the 32 Karat and CESI 8000 Plus software• Assign instrument or instrument administrator responsibility to users• Manage project privileges for each user
If the system administrator has logged on, then anyone using the computer might have allprivileges. The system administrator should always log out of administration mode before
leaving the workstation. There can be more than one system administrator, and we recommend
having a backup system administrator because there is no way to recover this account in thesoftware.

Instrument Administrator
The instrument administrator can use the 32 Karat software to add, remove, rename, or
configure instruments as well as to configure user access to instruments.

Users
Users are individuals who might be assigned some or all of the privileges listed in thefollowing table. They are assigned to one or more projects and one or more instruments,
and their privileges can vary both between projects and between instruments. Users have no
administrative privileges.
Table 1-1 Privileges
Category

Selectable Privileges

Method• Open Method• Save Method• Properties• Instrument Setup• Integration Events• Peaks/Groups• Advanced• Custom Report• System Suitability• Review Calibration• Calibrate

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Table 1-1 Privileges (continued)
Category

Selectable Privileges

Data• Open Data
• Save Data
• Properties (Description)• Manual Integration Fixes

Electronic
Signature• Sign Data Files• Multiple Files Sign
• Multiple File Revoke

Sequences• Open Sequence• Save Sequence• Process• Properties• Summary• Custom Report

Control• Preview Run• Single Run• Sequence Run• Lock Instrument• Print Setup• Manual Control (Idle Only)• Manual Control

Pretreatment1• Not used.

Advanced
Report• Open Advanced Report

Instrument
Activity Log• Save Advanced Report• Purge Log

1 The Pre-treatment privileges shown in the Privileges list are not used in the 32 Karat software and should be

excluded.
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Overview

Table 1-1 Privileges (continued)
Category

Selectable Privileges

Security• Access Common Folder

Projects
In the 32 Karat software, projects organize computer files and access privileges to prevent
unauthorized users from viewing or changing data and methods from projects to which they are
not assigned. When a project is added, the system administrator specifies the access rights
and location of the folder where all of the files used for acquiring data will be stored. For eachuser who has access to a project, specific privileges can be defined which will only apply in thatproject. A user might have different privileges in different projects.
Note: Project security will not be complete unless Windows security features are activated.
This includes removing all Delete privileges for standard or non-administrative authenticated or
local users. All other privileges should remain, such as Read, Write, Execute, and Modify. The
Modify privilege should only be applied to project file folders after the laboratory has validated
methods. Set the Modify privilege to prevent changes to the methods.
Only remove the Modify privilege from the project folders after the laboratory has validated themethods. Removing the Modify privilege prevents users from changing the names of the files forsecurity purposes.

The Default Project
Users have full access to the predefined Default Project. The Default Project should not be used
for any analyses for which compliance is important. For optimum security, remove access for
all users and non-administrative authenticated users from this project in File Explorer and the
32 Karat software. Do not delete the Default Project because it also deletes the report templates.
If the report templates are deleted then when a new project is added, the system administrator
will have to manually add the report templates from a project other than the Default project.

Instruments
For the CESI 8000 Plus system, there is one instrument when the software is installed. The
default configuration for the CESI 8000 Plus system is for CESI-MS.

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System Administration in the CESI 8000 Plus
Software
When system administration is enabled in the 32 Karat software, then any user privileges are
inherited by the CESI 8000 Plus software. If a user does not have access to a project in the
32 Karat software, then they will not have access in the CESI 8000 Plus software. Make anychanges to user privileges in the 32 Karat software.

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Software Configuration

2

Software Configuration

Use the Select Administration Wizard page to select a wizard to use to configure access andassign privileges. We recommend setting up the system administration in this order:
1.

Activate system administration mode. Refer to the section: Activate the System
Administration Mode.

2.

Add users. Refer to the section: Add Users.

3.

Add system administrators. Refer to the section: Add System Administrators.

4.

Add projects. Refer to the section: Add Projects.

5.

Add instruments. Refer to the section: Add an Instrument.

Figure 2-1 System Administration Wizards

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WizardDescription

User

Use this wizard to assign system administration or instrument
administration rights to users or groups defined on the system.
Give users access to instruments and projects specified in the Enterprisewindow. For more information, refer to the section: Configure the 32 Karat
Software .

Instrument

Use this wizard to assign user or group access to instruments and locations
specified in the Enterprise window. For more information, refer to thesection: Manage Instrument Access with the Instrument Wizard.

Project

Use this wizard to add new projects, assign users and groups to existing
projects, change existing project definitions, or remove projects from theEnterprise window.
A project consists of a set of Windows folders for the storage of methods,
data, sequences, and templates, as well as a project description. Using
projects makes sure that related data is stored in these designateddirectories that are consistent for all users. For more information, refer tothe section: Manage Projects Using the Project Wizard.

Restart Selected Select this check box to continue to use the selected wizard (User,
Wizard When
Instrument, or Project) after the current wizard task has completed. For
Finished
example, select this check box to set up multiple new projects without
starting the Project Wizard again.

Activate the System Administration Mode
When the system administration mode is activated, several security and administrative features
are enabled. When the 32 Karat software is installed, the system administration mode enables
several system administrator features.
By default, one user is configured as a system administrator.
• User name: cesi, password: 8000
When the 32 Karat software is installed, system administration mode is not enabled.
CAUTION: Potential Data Loss. Make sure that the user name and password for thesystem administrator is safely stored. If the user name, ID, or password for the systemadministrator is lost or forgotten, then the system administrator will not be able to accessthese features of the software or change them. After the system administrator modeis enabled, it can only be de-activated by the system administrator. Make sure to add
additional backup system administrator accounts if required.

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Software Configuration
The security of the system is closely linked to the security of the Windows operating system.
Make sure to match the security of the user or authenticated user in the operating system to thesoftware user.
1.

On the Windows desktop, double-click the 32 Karat icon.
The Enterprise window opens.

2.

Click Tools > Options.
By default, System Administration Mode is selected during a new installation.
• If the Options dialog is not available, then system administration is already activated. A
user must log on as a system or instrument administrator to access the Options dialog.
• If the Options dialog is activated, then the Options dialog opens. Go to step 3 to enablesystem administration mode.

3.

Open the Enterprise tab, click Enable user logins and permissions, and then click OK.
The Options dialog closes.

4.

As required, click Tools > Enterprise Login and then log on as a system administrator toconfigure the system administration features.

Add Users
1.

From the 32 Karat software, on the Enterprise window, click Tools > Options. By default,
System Administration Mode is selected during a new installation.
The Options window opens.

2.

From the Obtain user lists from list, select a location. Refer to the following tables to add
and configure users.

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Figure 2-2 Enterprise Tab in the Options Dialog: Internal data system

Field

Description

Obtain user
lists from

Select Internal data system: The list of users is maintained locally inthe 32 Karat software. This option is preferred for small organizations
with few users. The software administrator adds the user names andpasswords. Users can be added or removed locally.

Add User

To add a user, click Add User, and then specify a user name andpassword. To assign privileges to users, refer to the section: Manage
Access to the Software.

Remove User

Note: There is no option to cancel this action. The user is automaticallyremoved.
Select the user name from the list, and then click Remove User.

ChangePassword

To change the password for the selected user, click Change Password.

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Software Configuration

Field

Description

Allow
passwords tobe saved

Select to save the password of the user after initial logon. Subsequent
logons will not require the user to enter a password unless the 32 Karatsoftware is closed. This option is designed for systems where only one
user will be using the workstation.
Note: Be aware that allowing passwords to be saved decreases systemsecurity.

Enable single
user login
mode

Select to allow users to log on to all instruments once and not
individually.

Select to enable the current Windows user to log on to the 32 Karat
Automatically
software for all instruments. This option applies only for the domain
login as thecurrent domain controller in use.
user (Domain
Controller)

Figure 2-3 Enterprise Tab in the Options Dialog: Windows domain controller

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Field

Description

Obtain user
lists from

Select Windows domain controller: The 32 Karat software workstationmust be on a network. The list of potential users is the list of users
assigned to a particular network domain. In some large companies,
this could be thousands of people, or it could be limited to the people
in a single laboratory, depending on how the network is configured.
When the software is run under a domain controller, the user names
and passwords are those already assigned to that domain. To add or
remove users, a 32 Karat system administrator must also be a domain
administrator.
Note: If the Windows domain controller is used as the user list, anda domain on the network that is not under the control of the user isselected, then the user might lose access to the administrative featuresof the 32 Karat software, or the user might not be able to use thesoftware at all. In this situation, individuals who have domain control
must log in using their network password and assign administrative
control of the 32 Karat software to the user. If control is lost, thencontact sciex.com/request-support.

Select domains Select the domains to scan for users or groups.
to be scanned• Select Add Domain to specify a domain to be added to the possible(Domaindomains listed.
Controller)• Select Remove to remove a domain from the list.
• Select Refresh to update the list of current domains.
Allow
passwords tobe saved

Select to save the password of the user after initial logon. Subsequent
logons will not require the user to enter a password unless the 32 Karatsoftware is closed. This option is designed for systems where only one
user will be using the workstation.
Note: Be aware that allowing passwords to be saved decreases systemsecurity.

Enable single
user loginmode

If selected, users can log on once to the entire system and will not needto log in to each instrument individually.

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Software Configuration

Field

Description

Select to enable the current Windows user to log on to the 32 Karat
Automatically
software for all instruments. This option applies only for the domain
login as thecurrent domain controller in use.
user (Domain
Controller)

Figure 2-4 Enterprise Tab in the Options Dialog: Windows local PC

Field

Description

Obtain user
lists from

Select Windows local PC: The 32 Karat software uses the local
computer administrative tools for user lists and administrative accounts.

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Field

Description

Allow
passwords tobe saved

Select to save the password of the user after initial logon. Subsequent
logons will not require the user to enter a password unless the 32 Karatsoftware is closed. This option is designed for systems where only one
user will be using the workstation.
Note: Be aware that allowing passwords to be saved decreases systemsecurity.

3.

Enable single
user login
mode

Select to allow users to log on to all instruments once and not
individually.

Automaticallylogin as thecurrent
Windows user

Select to enable the current Windows user to log on to the 32 Karatsoftware for all instruments. This option applies only to local Windows
users.

Click OK to close the dialog.

Add System Administrators
1.

From the 32 Karat Software Enterprise window, click Tools > System Administration
Wizard.

2.

Click User and then click Next to continue.
The Select User window opens.

3.

Select the user to change and then click Next.

4.

Do one of the following:• Select System Administration to give this user full access to the system. This includes
access to the User Wizard, Instrument Wizard, and Project Wizard.
• Select Instrument Administration to give this user access to the instrument systems
only. This includes the ability to add, delete, and configure instruments.
Note: If neither check box is selected, then the user has no access to system administration
functions or instrument administration functions.

5.

After assigning privileges, click Finish to exit the User Wizard.

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Software Configuration

Add Projects
1.

From the 32 Karat Software Enterprise window, click Tools > System Administration
Wizard.

2.

Click Create a new project to define a new project and then click Next to continue.
Figure 2-5 Select Project Action

The General Project Settings page opens.
3.

Type a descriptive name and location for the project.
Tip! Click the folder icon to select the project location.
Note: If path names are manually typed, then all paths must be entered using universal
naming conventions. For example, \\ntserver\projects.
The project folder is automatically populated with default folders: Method, Data,
Sequences, and Templates.

4.

After creating the projects, click Next to continue or click Finish to exit the Project Wizard.

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Software Configuration
5.

On the General Project Settings page, from the list, select a specific audit trail for the projector click All audit trails.
Figure 2-6 General Project Settings Page

Field

Description

Predefined
audit trail
reasons

Shows the audit trail reasons that can be selected by users.

Reason to beadded

To add a reason, type a reason and then click Add. The list of definedreasons is shown in the List of reasons field.

List of reasons• To delete a reason, select the reason, and then click Delete.
• To change the order of the reasons, select a reason, and then click
Move Up or Move Down.

Allow users totype their own
reasonSelect to let users type their own audit trail reasons.

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Software Configuration

Field

Description

Automaticallyenable audit
trail

Select to enable the audit trail for all files of the specified type added inthis project. Select one of the following options:• Prompt for reason at every change. Select to prompt users for areason whenever a change is made.
• Prompt for reason when saving. Select to prompt users are for areason for change only when a file is saved.
• Do not prompt for reason. Select if a prompt for a reason will not beshown.

6.

Click Next to continue or click Finish to exit the Project Wizard.

7.

Select the electronic signatures applicable to the project.

8.

Click Next to continue or click Finish to exit the Project Wizard.
The Set User Privileges page is shown.
Figure 2-7 Set User Privileges

9.

Select the user.

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Software Configuration
10. In the Unassigned privileges list, select the required privileges from those shown and thenclick the green arrow to move them to the Assigned privileges list. Privileges assigned
from this location apply to the entire project. If required, individual user privileges can bechanged later with the User Wizard.
The privileges shown might be assigned as groups of items or as individual items.
Note: The Calibrate privilege enables the user to run a calibration sample to update themethod calibration. To add or change the calibration parameters in a method, the user musthave the Save Method privilege assigned.
11. Click Next to continue or click Finish to exit the Project Wizard.
12. Select the level of signing authority for each user assigned to this project.
A user can only revoke electronic signatures on a data file if no one with higher signingauthority has signed the data file. If none of the users assigned to this project are assigned
electronic signature roles for this project, then a message is shown.
Note: Electronic signature roles apply only if domain user logons or local Windows PC user
logons are used, not when the internal data system logon is used.
13. Click Finish to exit the Project Wizard.

Add an Instrument1.

Open the 32 Karat software.

2.

In the Enterprise window, right-click, and then click New > Instrument.

3.

Type a name for the instrument and then click anywhere in the window.

4.

Add locations and instruments until the system enterprise matches the company orlaboratory configuration.

5.

Configure the instrument. Refer to the section: Manage Instrument Access with theInstrument Wizard.

Configure Electronic Signatures
Electronic signature features are set by the system administrator and allow the user to acquire,review, or sign off on data.
The 32 Karat software includes controls to facilitate 21 CFR part 11 compliance. Activating
electronic signatures helps with this compliance process by enabling electronic audit trails to begenerated in addition to electronic record keeping.
A user can only revoke electronic signatures on a data file if no one of higher signing authority
has signed the data file. If none of the users assigned to this project are assigned electronic
signature roles for this project, a message is shown.
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After someone has electronically signed a data file, it cannot be revoked by someone with alower signature role. The electronic signature roles defined here specify the types of electronic
signature roles for to this project.
1.

From the Tools menu, click System Administration Wizard.

2.

Click Project and then click Next.

3.

Click Change a project's settings and then click Next.

4.

Click the project and then click Next.

5.

Click Next, change the audit trail settings, and then click Next.

6.

Define the electronic signature roles for the selected project and then click Finish or Next tochange any other settings for the project
Figure 2-8 Electronic Signature Roles Page

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7.

Field

Description

Role Names

Shows the default names of the signature roles, along with the signature
reasons. Change a role name by highlighting it, and then typing the newrole name.

Number ofLevelsSelect the number of signature levels for this project. The default value
is 3.

Electronic
Signature
Reasons

Current signature reasons are shown.

(Optional) To add, change, or delete Electronic Signature Reasons, click the Modify button.
• To add a reason, type a reason and then click Add. The list of defined reasons is shownin the List of reasons field.
• To delete a reason, select the reason, and then click Delete.
• To change the order of the reasons, select a reason, and then click Move Up or Move
Down.
a.

8.

Click OK to save the new settings.
The Define Electronic Signature Roles window opens.

Click Finish or Next to change any other settings for the project

Configure the 32 Karat Software
When the 32 Karat software is started, the Enterprise window opens. The Enterprise window
is the main system module that controls many smaller applications, one of which is System
Administration.
Use the software wizard to configure the following:• Assign system administration rights to users or groups defined on the system.
• Assign instrument administration rights to users or groups defined on the system.
• Define the instruments or projects that are available to users or groups defined on thesystem.
• (Only applicable to non-domain workstations) Add or delete users from the system.
1.

From the 32 Karat Software Enterprise window, click Tools > System Administration
Wizard.

2.

Click User and then click Next to continue.

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Note: Select the Restart selected wizard when finished option to add or change morethan one user. If this option is selected, then the User Wizard starts again after Finish isclicked.
The Select User window opens.
3.

Select the user to change and then click Next.

4.

After assigning privileges, click Next to continue or click Finish to exit the User Wizard.

5.

In the Available Instruments list, select the instruments for this user by double-clicking the
instrument.
Tip! Alternatively, select the instrument and then click the green arrow to move it to theSelected Instruments list.
Note: If no instruments are shown in the Available Instruments list, then expand theEnterprise icon by double-clicking locations until the required instruments are shown.
Assign all instruments in a laboratory or location to a user or group by selecting the entire
location from the Available Instruments list. If a location (for example, Enterprise) is shownin the Selected Instruments list, then all instruments in that location are selected.

6.

After selecting the instruments, click Next to continue or click Finish to exit the User
Wizard.

7.

In the Available Projects list, select the projects for this user by double-clicking them.
Tip! Alternatively, select the project and then click the green arrow to move it to the Selected
Projects list.

8.

After selecting projects, click Next to continue or click Finish to exit the User Wizard

9.

Select the required privileges from those shown in the Unassigned privileges list and thenclick the green arrow to move them to the Assigned privileges list. The privileges shown
might be assigned as groups of items or as individual items.
Note: The Calibrate privilege lets the user run a calibration sample to update the method
calibration. To add or change the calibration parameters in a method, the user must have
the Save Method privilege assigned.
Note: Select multiple projects or privileges by using Shift and Ctrl and using the green
arrow to assign them. Select a project or privilege and select Ctrl + A to select all projects
or privileges.

10. After setting user privileges for each project, click Next to continue or click Finish to exit theUser Wizard.

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11. Select the level of signing authority for the user. A user can only revoke electronic
signatures on a data file if no one of higher signing authority has signed the data file.
Note: Electronic signature roles apply only if domain user logons or local Windows PC user
logons are used, not when the internal data system logon is used.
12. After the electronic signature roles for the user are defined, click Finish to exit the User
Wizard.

Instrument Logon
After users have been added to the data system and their privileges assigned to various
instruments and projects in the database, they can start instruments to which they have been
assigned.
If users attempt to open an instrument from the 32 Karat Software Enterprise window, then they
are prompted to enter their user name, their password, and select the project to which they are
logging on.
If the Windows domain logon or domain controller option has been selected, then the domain
selection window is also shown, which the user can select as well.
All instrument logons are saved to the instrument activity log, and the system administrator canalso set up additional security features to prevent unauthorized access to the system. Refer tothe section: Worksheets.

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Manage Access to the Software

3

Use the System Administration Wizards to easily manage the system administration functions in
the 32 Karat software. System administrators can add projects, add users, and assign the user
permissions. Projects are represented by Windows folders that are recognized by the software.
Access for each project is set by the system administrator.
Note: The project and instrument name must match what is shown in the CESI 8000 Plus and
32 Karat software. Do not use the special character “-” in a project or instrument name.
Three wizards are available. Each provides a pre-defined, step-by-step process for managing
users and projects.

Manage Projects Using the Project Wizard
The Project Wizard is used to set up new projects, assign users and groups to existing projects,
change existing project definitions, or remove projects from the 32 Karat Software Enterprisewindow. A project consists of Windows folders used to create folders to store methods, data,
sequences, and templates, along with a project description.
Projects facilitate data management by making sure that related data are stored in designatedfolders that are consistent for all users.
1.

From the 32 Karat Software Enterprise window, click Tools > System Administration
Wizard.

2.

Click Project and then click Next to proceed.
Note: Select the Restart selected wizard when finished option to add or edit more than
one project. When this option is selected, the Project Wizard starts again after Finish isclicked.
The Select Project Action dialog opens.

3.

Select one of the following options:

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Figure 3-1 Select Project Action Dialog

4.

After assigning projects, click Next to continue. Refer to the sections: Add Projects, Assign
Users to a Project, and Remove Projects.

Assign Users to a Project1.

From the 32 Karat software Enterprise window, click Tools > System Administration
Wizard.

2.

Click Project and then click Next to proceed.

3.

Click Assign users to a project and then click Next.
The Select Project window is shown.

4.

Select the project to which to assign users and click Next.

5.

Select the number of signature levels for this project. The default level is 3.
The default names for the various signature roles are shown, along with the signature
reasons. Change a role name by highlighting it, and then changing the role name.
The current signature reasons are shown.

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6.

To add, change, or delete Electronic Signature Reasons, click Modify.
• To add a reason, type a reason and then click Add. The list of defined reasons is shownin the List of reasons field.
• To delete a reason, select the reason, and then click Delete.
• To change the order of the reasons, select a reason, and then click Move Up or Move
Down.

7.

Click OK to save the new settings.
The Define Electronic Signature Roles window opens.

8.

Click Next to continue to the Select Users window or click Finish to exit the Project Wizard.

9.

Select the user.

10. In the Unassigned privileges list, select the required privileges from those shown and thenclick the green arrow to move them to the Assigned privileges list. Privileges assigned
from this location apply to the entire project being added. Individual user privileges mightthen be later modified using the User Wizard interface.
The privileges shown might be assigned as groups of items or as individual items.
Note: The Calibrate privilege enables the user to run a calibration sample to update themethod calibration. To add or change the calibration parameters in a method, the user musthave the Save Method privilege assigned.
11. Click Next to continue to the Select Users window or click Finish to exit the Project Wizard.
12. Select the level of signing authority for each user assigned to this project.
A user can only revoke electronic signatures on a data file if no one of higher signingauthority has signed the data file. If none of the users assigned to this project are assigned
electronic signature roles for this project, a message is shown.
Note: Electronic signature roles apply only if domain user logons or local Windows PC user
logons are used, not when the internal data system logon is used.
13. Click Finish to exit the Project Wizard.

Manage Instrument Access with the Instrument
WizardThe Instrument Wizard is used to assign a user or group access to instruments or locations
defined in the Enterprise window of the 32 Karat software.
1.

From the 32 Karat Software Enterprise window, click Tools > System Administration
Wizard.

2.

Click Instrument and then select Next to continue.

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Note: Select the Restart selected wizard when finished check box to add or edit morethan one instrument or location. When this option is selected, the Instrument Wizard starts
again after Finish is clicked.
3.

Select the individual instrument or the location containing multiple instruments to which toassign a user or group access and then click Next.
The Select Users window opens.

4.

Do one of the following to select users:
Table 3-1 Select Users
Field

Description

Internal Data
SystemSelect to highlight the name of the user to add or change. Then selectone of the green or red arrows to move the user to or from the
instrument.

Windows
DomainController

Select the domain from the list of domains available. A domain is afunctional portion of the network that has been set up by the Windows
domain controller. After selecting the domain, specify the user or groupand then click Check names to locate them in the domain.
• To select a group, click Groups and then specify the group nameand select Check names to locate the group on the domain. Then
select the valid group and click the green arrow to move the group to
the instrument.
• To select an individual user, select Users to specify a user name andlocate the users in the domain. Then click the green arrow to movethe user to the instrument.

Windows Local Managed by Windows Local PC administrative tools.
PC
5.

Click Finish to exit the Instrument Wizard.

Change Project Settings
1.

In the System Administration Wizard, select Project.

2.

Click Change a project's settings and then click Next.
The General Project Settings window is shown.

3.

Select the project to which to assign users and then click Next.
When changing project settings, the project name or file locations cannot be changed. Thiswindow lets users specify or change the optional text description, for the selected project.

4.

Click Next to continue or click Finish to exit the Project Wizard.

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5.

Select a specific audit trail to which the settings will apply or click All audit trails.
Figure 3-2 General Project Settings

Field

Description

Predefined
audit trail
reasons

Define the audit trail reasons that can be selected by users.

Reason to be
added• To add a reason, type a reason and then click Add. The list of
defined reasons is shown in the List of reasons field.
• To delete a reason, select the reason, and then click Delete.
• To change the order of the reasons, select a reason, and then click
Move Up or Move Down.

Allow users totype their own
reasonIf selected, allows users to type a reason.

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Field

Description

Automaticallyenable audit
trail

If selected, the audit trail is automatically enabled for all files of thespecified type added in this project.

Prompt forIf selected, users are prompted for a reason whenever a change isreason at every made.
changePrompt forreason whensavingIf selected, users are prompted for a reason for change only when a fileis saved.

Do not prompt
for reason

If selected, a prompt for reason is never shown.

6.

Click Next to continue or click Finish to exit the Project Wizard.

7.

Select the electronic signatures applicable to the project.
Table 3-2 Electronic Signature
Field

Description

Role Names

Default names for the various signature roles are shown, along withthe signature reasons. Change a role name by highlighting it, and thenchanging the role name.

Number ofLevelsSelect the number of signature levels for this project. The default is
3. After someone has electronically signed a data file, it might not be
revoked by someone with a lower signature role.

Electronic
Signature
Reasons

Current signature reasons are shown. To add, change, or delete
Electronic Signature Reasons, click the Modify button.
• To add a reason, type a reason and then click Add. The list of
defined reasons is shown in the List of reasons field.
• To delete a reason, select the reason, and then click Delete.
• To change the order of the reasons, select a reason, and then click
Move Up or Move Down.

8.

Click Next to continue or click Finish to exit the Project Wizard.

9.

Select the user.

10. In the Unassigned privileges list, select the required privileges from those shown and thenclick the green arrow to move them to the Assigned privileges list. Privileges assigned

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Manage Access to the Softwarefrom this location apply to the entire project being added. Individual user privileges mightthen be changed later with the User Wizard interface.
The privileges shown can be assigned as groups of items or as individual items.
Note: The Calibrate privilege enables the user to run a calibration sample to update themethod calibration. To add or change the calibration parameters in a method, the user musthave the Save Method privilege assigned.
11. Click Next to continue or click Finish to exit the Project Wizard.
12. Select the level of signing authority for each user assigned to this project.
A user can only revoke electronic signatures on a data file if no one with higher signingauthority has signed the data file. If none of the users assigned to this project are assigned
electronic signature roles for this project, then a message is shown.
Note: Electronic signature roles apply only if domain user logons or local Windows PC user
logons are used, not when the internal data system logons are used.
13. Click Finish to exit the Project Wizard.

Remove Projects
1.

In the System Administration Wizard, select Project.

2.

Click Remove projects and then click Next.
The Select Project window is shown.

3.

Select the project to remove and then click Finish.
The selected project is removed from the system.
Note: When a project is removed using the wizard, access to its directories is removed. The
actual data directories defined for the project are not deleted.

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Additional Features

4

The System Administrator can add reports for various user aspects of the CESI 8000 Plus
system, assign global security settings to the system, and add a system activity log.

The Options Dialog
The Options dialog is where system administration mode is enabled or disabled, users andpasswords are added, and email notifications configured. In addition, system administrators canconfigure logging, audit trails, activity logs, extended security, and software behavior when thecomputer is idle.

Workstation Tab
Figure 4-1 Workstation Tab Options

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Field

Description

EnterprisemachineLeave this field blank.

Status update
interval

From the 32 Karat Software Enterprise window, click View > Detail to show
the Instrument status. The current status of each instrument is shown. For
example, Idle, Available, In Use.

Display thefollowing
warnings andconfirmations

Select this option to open a confirmation dialog when the 32 Karat software
is closed.

Set General Options
1.

On the Windows desktop, double-click the 32 Karat icon.
The Enterprise window opens.

2.

Click Tools > Options > General. This option allows the system administrator toautomatically assign security settings to the entire system.
Note: We recommend that Enable system activity log is selected. Refer to the following
figure.

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Figure 4-2 General Tab

Field

Description

Save All
Analysis
Results

If this check box is selected, then each time a data file is analyzed,
the results are saved in the data file and are identified with the username and date of the analysis. Identification makes it possible to open
a specific result from the Open Data dialog in the Instrument Control
program window, using the Open with Results option using the Options
section and then selecting From Results for Method and the Results
date and time in the Results field using the ellipses button.
If this check box is not selected, then only the original and most recent
results are saved in the file.

Logging Options
Automaticallyenable method
audit trail

If this option is selected, then the method audit trail is enabled whenevera method is saved.

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Field

Description

If this option is selected, then the sequence audit trail is enabled
Automaticallywhenever a sequence is saved.
enablesequence audit
trail
If this option is selected, then the instrument activity log must be
Activity log
archived before it can be purged.
purge
authorized only
after archive
Enable system
activity log

If this option is selected, then the system activity log is enabled. Afterthe log is enabled, it cannot be turned off. We recommended that thisfeature is enabled.

Security Options
Extended
Security

If this option is selected, then a checksum is calculated whenever adata file is closed. When the file is subsequently opened, its checksum
is verified first. If the verification fails, then the calculated checksum forthe file does not match the one previously calculated for the file, the filecannot be opened, and an error is posted in the instrument activity log.
Checksum verification is enterprise-wide.
Note: Extended security does not affect security settings in nonnetworked environments (Stand-alone).
In addition, the Extended Security function provides additional security
to the enterprise in the following ways.
• All system administrators have full access to everything.
• All non-system administrators have read/execute rights to project
directories for which they have rights.
• All non-system administrators have read/write/execute rights toproject subfolders for which they have rights. This means that users
in the project without system administrator rights will not be able toadd subdirectories or files under the project directory, and they will
not be able to rename or delete files under the project subfolders.
Directories can still be added in project subfolders, but only throughthe 32 Karat software.

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Field

Description

Log out
Current User
When Idle For

If this option is selected, then type a number, in minutes. If no mouse or
keyboard activity is detected during the specified number of minutes insystem administration mode, then the system does the following:• Cancel any open dialogs• Cancel any wizard in progress• Log out of Administrative Mode
Note: This feature applies to the Enterprise window only, and does
not affect any open instrument program windows.

Cancel an InProgress
Electronic
Signature
When Idle For

If an electronic signature is in progress, then it will be cancelled if there
is no input for the specified number of minutes.

System Administration Report Utility
The 32 Karat software includes a system administration report utility. Use this utility to show
the configuration for project settings, users and permissions, instrument configurations, andenterprise-wide settings. Refer to the following figure.

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Figure 4-3 System Administration Report Utility

Create System Administration Report
1.

From the Tools menu, click System Administration Report.

2.

elect the options and then click Go.
The Report window opens

3.

(Optional) Click File > Print Report in the report to print the report.

4.

Click the Close box to close the report.

View the System Activity Log
1.

From the 32 Karat software Enterprise window, click Tools > Enterprise Login and then log
on as an instrument or system administrator.

2.

Click File > System Activity Log > Display Log.

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Figure 4-4 System Activity Log

3.

Right-click in the System Activity Log for additional actions.
Figure 4-5 System Activity Log Menu Options

Menu Item

Description

Show Detail

Click to show the information for the currently selected entry.

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Menu Item

Description

Manual Entrya.

Click to add a manual entry to the log.

b.

Type the information and then click OK.
Figure 4-6 System Activity Manual Entry Dialog

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Menu Item

Description

ExportOnly available to system administrators.
Figure 4-7 System Activity Export

Archivea.

Click to export the log or the selected range of the log to a specific
file.

b.

Type a file name in the File name field.

c.

Select a file type from the Save as type list.

d.

Select a record range.

e.

Click Save to save the system activity log for the range selected in
the file specified.

Only available to system administrators.
In the dialog that opens, select the location for the archive file. A
default name is assigned, with the logarc extension. This file canbe viewed using the Log Viewer, which can be opened from: C:\32Karat\LogViewer.exe.
Tip! Access the archive from the Start menu: Click Start > CESI 8000
Plus Software > Log Viewer.

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Menu Item

Description

Purge

Only available to system administrators.
The purge activity varies based on options selected in the Options
dialog. Refer to the section: Set General Options.
• If the Activity Log Purge authorized only after archive option is
selected, then the System Activity Log Archive dialog opens first.
After confirmation, the log is purged.
• If the Activity Log Purge authorized only after archive check box
is not selected, then a confirmation message is shown. If the user
confirms, then the purge operation occurs.
After the log is purged, an entry is added to the System Activity Log
stating that the purge occurred.

4.

Print all

Click to print all of the rows in the log.

Print Selection

Click to print only the selected rows of the log.

RefreshClick to update the log.

Click Close to close the System Activity Log dialog.

Configure Email Notifications
For more information about configuring events and generating email notifications, refer to the
document: Help that comes with the software.
1.

On the Windows desktop, double-click the 32 Karat icon.
The Enterprise window opens.

2.

Click Tools > Options > General. This option allows the system administrator toautomatically assign security settings to the entire system.

3.

Click the E-mail tab and then refer to the following table to configure notifications.

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Figure 4-8 Email Tab Options

Field

Description

EnableSelect this check box to enable the settings for email. When cleared,
controls are disabled and previously-configured notifications are notsent by instruments.

SMTP

Select this option if SMTP is to be used for email.

Use thisaddress in the‘From’ fieldSpecify an email address of a valid user.

Mail server
address

Specify the SMTP-compliant email address of the local mail server towhich the email notification should be sent. This field can be a valid
TCP/IP address or a URL name understood by the network.

Login
Authentication

Select this option to provide a valid user name and password that might
be required for SMTP.

SMTP PortThis field is used to specify the TCP/IP port number used for SMTP
mail.

MAPI

Select this option if MAPI is to be used for email.

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Field

Description

ProfileSpecify the MAPI Profile to be used for sending email.

Test

Select this option to have the system try to• connect to the email server and test the port (for SMTP)• determine if the profile exists on the server (for MAPI)This function shows a message indicating the success or failure of theconnection attempt.

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Example Administration Setup

5

In this section, a hypothetical laboratory is described. To suit the needs of this laboratory, various
system administration features are enabled. To help organize the system, use the worksheets inthe section: Worksheets

Laboratory Personnel
In this example, a small pharmaceutical laboratory has three employees consisting of amanager, a technician, and an equipment maintenance person named as follows:• Laboratory Manager: LabMgr• Laboratory Technician: Tech
• Equipment Maintenance: InstAd
In this laboratory, various analyses of proteins, nucleic acids, and small molecules are
performed. The laboratory manager has spent a great deal of time developing and validating
a number of system methods. The laboratory technician will begin using these methods while
the laboratory manager continues development on new methods. The equipment maintenanceperson performs daily performance qualification on the instrument and system maintenance as
required.
The laboratory manager sets up the system administration as described in the following
sections.
Table 5-1 Laboratory Personnel
Personnel

Description

Data System
Users

The following users are added to the data system:• LabMgr: System Administrator• InstAd: Instrument Administrator• Tech: Standard User
Refer to the section: Assign Users to a Project.

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Table 5-1 Laboratory Personnel (continued)
Personnel

Description

System Projects

The lab manager adds the following projects:• Protein• Nucleic Acid
• Small Molecules• Performance
Refer to the section: Add Projects.

Project Access

The lab manager grants project access as follows:• LabMgr: Protein, Nucleic Acid, Small Molecules, Performance• InstAd: Performance• Tech: Protein
Refer to the section: Assign Users to a Project.

Signature
Authority

The following signature authority is granted:• LabMgr: Lab Manager on all projects, all permissions• InstAd: Technician on Performance project, all permissions• Tech: Technician on Protein project, all permissions
Refer to the section: Configure Electronic Signatures.

SystemInstruments

The Instrument Administrator adds the following instruments:• Protein: LabMgr, InstAd, and Tech as users• Development: LabMgr and InstAd as user
• Performance: InstAd as user
Refer to the "CESI 8000 Plus Instrument Configuration” topic in the
Configuration section of the 32 Karat software Help.

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Table 5-1 Laboratory Personnel (continued)
Personnel

Description

Users

The lab manager hires a bio-statistician. Among other responsibilities, this
employee reviews data acquired by the technician before submission to the
manager for approval.
The system administrator changes the Protein Project as follows:

Electronic
Signature Roles

1.

The lab manager selects the Enterprise login from the Tools menu andthen enters the appropriate user name and password.

2.

The lab manager selects Options from the Tools menu. The Analyst
User is added to the Enterprise tab.

3.

The lab manager opens the System Administration Wizard from theTools menu.

4.

The lab manager uses the Project Wizard to change the Protein
project. The Shift Supervisor role name is changed to Analyst. The
Analyst user is granted all Protein project permissions except for thecontrol features.

The Electronic Signature Roles are as follows:• LabMgr: Lab Manager on all projects• InstAd: Technician on Performance project• Tech: Technician on Protein project• Analyst on Protein project

Process Completion
After the changes are complete, the Lab Manager clicks Enterprise Logout. This example
shows how the system administration can be used in a laboratory setting.
Use copies of the worksheets to help plan the System Administration settings that are mostappropriate for the laboratory. Refer to the section: Worksheets

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6

Worksheets
Table 6-1 Enterprise Options Dialog
Project Name

User

Methods
Open Method
Save Method
Properties
Instrument Setup
Integration Events
Peaks/Groups
Advanced
Custom Report
System Suitability
Review Calibration
Calibrate
Data
Open Data
Save Data
Properties (Description)
Manual Integration Fixes
Electronic Signature
Sign Data Files
Multiple File Sign
Multiple File Revoke
Sequences
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Table 6-1 Enterprise Options Dialog (continued)
Project Name

User

Open Sequence
Save Sequence
Process
Properties
Summary
Custom Report
Control
Preview Run
Single Run
Sequence Run
Lock Instrument
Print Setup
Manual Control (Idle Only)
Manual Control
Advanced Reports
Open Advanced Report
Save Advanced Report
Instrument Activity Log
Purge Activity Log
Security
Access Common Folder
Notes

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Table 6-1 Enterprise Options Dialog (continued)
Project Name

User

Table 6-2 User, Instrument Administrator, and System Administrator
User

Instrument Administrator

System Administrator

□
□
□
□
□
□
□
□
□
□

□
□
□
□
□
□
□
□
□
□

Table 6-3 System and User Assignment
SystemUser

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User

User

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Table 6-3 System and User Assignment (continued)
SystemUser

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User

User

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Contact Us

Contact Us
Customer Training• In North America: NA.CustomerTraining@sciex.com• In Europe: Europe.CustomerTraining@sciex.com• Outside the EU and North America, visit sciex.com/education for contact information.

Online Learning Center• SCIEX Now Learning Hub

Purchase Supplies and Reagents
Reorder SCIEX supplies and reagents online at store.sciex.com. To set up an order, use theaccount number, found on the quote, order confirmation, or shipping documents. Currently,
customers in the United States, United Kingdom, and Germany have access to the online store,
but access will be extended to other countries in the future. For customers in other countries,
contact a local SCIEX representative.

SCIEX Support
SCIEX and its representatives maintain a staff of fully-trained service and technical specialists
located throughout the world. They can answer questions about the system or any technicalissues that might arise. For more information, visit the SCIEX website at sciex.com or contact us
in one of the following ways:• sciex.com/contact-us• sciex.com/request-support

CyberSecurity
For the latest guidance on cybersecurity for SCIEX products, visit sciex.com/productsecurity.

Documentation
This version of the document supercedes all previous versions of this document.
To view this document electronically, Adobe Acrobat Reader is required. To download the latest
version, go to https://get.adobe.com/reader.

CESI 8000 Plus High Performance Separation-ESI
Module54/55

System Administration Guide
RUO-IDV-05-3898-D

Contact Us

Note: To request a free, printed version of this document, contact sciex.com/contact-us.

System Administration Guide
RUO-IDV-05-3898-D

CESI 8000 Plus High Performance Separation-ESI
Module55/55