ChromLab Security Edition
ChromLab Security Edition
ChromLab Software
Security Edition
User Guide
Version 6.1
ChromLab Software,
Security Edition
User Guide
Version 6.1
Bio-Rad Technical Support Department
The Bio-Rad Technical Support department in the U.S. is open Monday through Friday,
5:00 AM to 5:00 PM, Pacific time.
Phone: 1-800-424-6723, option 2
Email: [email protected] (U.S./Canada Only)
For technical assistance outside the U.S. and Canada, contact your local technical support
office or click the Contact us link at www.bio-rad.com.
Notice
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Bio-Rad reserves the right to modify its products and services at any time. This guide is
subject to change without notice. Although prepared to ensure accuracy, Bio-Rad assumes
no liability for errors or omissions, or for any damage resulting from the application or use
of this information.
BIO-RAD is a trademark of Bio-Rad Laboratories, Inc.
All trademarks used herein are the property of their respective owner.
Copyright © 2020 by Bio-Rad Laboratories, Inc. All rights reserved.
Table of Contents
Chapter 1 Introduction 7
U.S. FDA 21 CFR Part 11 Compliance 7
Finding Out More 8
Audit Logs 64
General Audit Log 65
Run Audit Log 66
Analysis Audit Log 67
Viewing Audit Logs 68
Signed Reports 72
Signed Method Reports 72
Signed Run Reports 73
Signed Analysis Reports 74
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Table of Contents
When enabled, Security Edition provides the necessary features to permit ChromLab to
operate in compliance with Title 21 of the U.S. Code of Federal Regulations Part 11 (21
CFR Part 11) within a closed system. A closed system is defined as “an environment in
which system access is controlled by the persons who are responsible for the content of
electronic records that are on the system” (Section 11.3 (b) (4)).
Note:
n The security controls built into ChromLab must be properly configured and
administered by the ChromLab administrator(s) in your organization in order to be
secure and in compliance with 21 CFR Part 11.
User Guide | 7
Chapter 1 Introduction
More information about the NGC chromatography systems and ChromLab software is
available from the following sources.
n The NGC Chromatography Systems and ChromLab Software User Guide is available
on the NGC Chromatography Systems Software USB drive. This document explains
how to use ChromLab software to control the NGC instrument, run protein separations
and other operations manually, program methods to automate purification runs,
evaluate the results, and print experiment reports.
Note: Click the Bio-Rad logo in the upper right corner of any ChromLab window to
launch the Bio-Rad website.
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Chapter 2 Preparing to Share the ChromLab Database
A ChromLab workstation has ChromLab Software, Security Edition installed but is not
connected to an NGC system. From this computer you can create methods and save
them to the shared database. You can also access, view, and edit ChromLab data files
that are saved on the shared database.
Data from the connected NGC system are saved to the shared database and are
accessible to users from any computer running ChromLab software.
Multiple ChromLab computers can simultaneously connect to the same NGC system.
A user assigned the Advanced User role can log into any computer and take control of
the system. This is useful in the event that the controlling computer is locked or the
user performing a run is not available and there is an immediate need to stop the
instrument. In this environment, only one ChromLab computer can control an NGC
system at a time. All other NGC computers have View access to the system.
Note: Any user can take control of the NGC system using the system’s touch
screen. The touch screen is never in View mode.
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Chapter 2 Preparing to Share the ChromLab Database
Preparing your site to share a ChromLab database requires the following tasks:
2. Verify that the central computer meets the hardware and software requirements.
Site Requirements
The room and power requirements for installing NGC systems and ChromLab software in a
shared database environment are the same as those for local installations.
Note: Ensure that the network hosting the ChromLab computers and NGC systems
supports Internet Protocol version 4 (IPv4).
For specific information, see the chapter Preparing the ChromLab Computer in the NGC
Chromatography Systems and ChromLab Software Installation Guide.
System Requirements
The system requirements for the central ChromLab computer or server are very similar to
those for the local and remote installation of ChromLab with the differences bolded in this
table.
RAM 8 GB
Important: Do not install Security Edition on a Windows Server computer that you plan to
upgrade to, or that has, a newer version of Microsoft SQL Server installed.
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Chapter 2 Preparing to Share the ChromLab Database
Before setting up the shared database, determine which computer will host the shared
database. Choose a clean computer (one that does not have an existing installation of
ChromLab) to host the shared database.
Notes:
n Bio-Rad strongly suggests that you host the shared database on a dedicated computer
or server that is regularly backed up.
n Ensure that all remote computers and NGC systems have access to that computer.
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Chapter 3 Preparing the Central Computer and NGC Systems
1. Install ChromLab software on the central computer and all remote computers and NGC
systems.
2. Verify that all NGC systems and remote ChromLab computers can access the subnet
on which the central ChromLab computer will reside.
See your system or network administrator for information about subnets and setup.
See your system administrator for information about assigning a static IP address to
the central computer.
6. Verify that the central computer can access each NGC system.
See Verifying that All NGC Systems Can Reach the Central Computer on page 23.
Important: Restoring backup data overwrites existing ChromLab data. Perform this
task only once, and carefully select the database to back up and restore.
a. Navigate to C:\ProgramData\Bio-Rad\NGC\Database.
Ensure that the disk on which you plan to save the backup zip file has free disk space
that is at least equal to the size of the NGC database.
3. On the Start menu, select ChromLab > ChromLab Administration and log into
ChromLab Administration.
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Chapter 3 Preparing the Central Computer and NGC Systems
5. In the Backup section, click Browse to browse to a location into which to save the NGC
backup (.sbk) file.
Note: Ensure that the central computer can access the target location.
6. Click Backup.
ChromLab displays a status bar of the backup progress. Depending on the size of your
database, the backup can take some time.
You can set a reminder to back up the central database. The reminder appears on the
ChromLab computer at the time interval you set. From the ChromLab Administration
Backup Reminder dialog box, you can open ChromLab Administration and perform the
backup.
Alternatively, you can close the reminder dialog box and perform the backup at another
time.
1. Open ChromLab Administration and select the Backup and Restore tab.
2. In the Backup Reminder section, verify the Set Reminder checkbox is selected.
3. Use the up and down arrows to set the numeric interval for the reminder and select
either Daily, Weekly, or Monthly from the dropdown list.
4. Click Apply.
u In the Backup Reminder section, clear the Set Reminder checkbox and click Apply.
Important: Restoring backup data overwrites existing ChromLab data. Ensure the
central computer does not have existing ChromLab data.
Perform this task on the central ChromLab computer. Ensure the computer has free disk
space that is at least equal to the size of the backup file.
1. Verify that you have installed ChromLab 6.1 on the central computer.
3. In the Restore section, click Browse to browse to the location where you saved the
NGC backup (.bak) file.
4. Click Restore.
ChromLab displays a status bar of the restore progress. Depending on the size of your
database, the restore can take some time.
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Chapter 3 Preparing the Central Computer and NGC Systems
Important: The NGC system must restart to apply the IP address changes.
1. On the instrument touch screen, select System Information on the dropdown menu.
3. In the Configure IP Address dialog box, select Use the following IP address and
provide the IP address, subnet mask, default gateway, and DNS server information
specific to your site.
Tip: See your system or network administrator for the appropriate IP settings.
n Subnet mask — the numeric filter used to define the subnet to which the IP
address belongs.
n Default gateway — (required only if you plan to install the shared ChromLab
database on a separate subnet or access the NGC system from ChromLab
computers that are on another subnet) this is the IP address of the node that
allows communication between the subnets.
n DNS Server — the IP address of the node that translates a server name to its IP
address.
4. Click OK.
6. To verify that the IP address changed successfully, open the System Information dialog
box from the dropdown menu and view System IP Address in the General tab.
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Chapter 3 Preparing the Central Computer and NGC Systems
1. On the instrument touch screen, select System Information on the dropdown menu.
The System Information dialog box appears displaying the General tab.
2. Locate and record the system name and system IP address information in the General
tab.
If two or more NGC systems have the same name, you must change one name so that
each is unique.
1. On the instrument touch screen, select System Settings on the dropdown menu.
3. On the System Name tab, type a new name for the system and click OK to save the
change and close the System Settings dialog box.
4. To verify that the name changed successfully, open the System Information dialog box
from the dropdown menu and view System Name in the General tab.
If the NGC systm can reach the central computer, a response similar to the following
appears:
Pinging <NGC_system_name>
3. Perform Step 2 for each NGC system and remote computer you plan to connect to the
central computer.
Important: If you experience a problem accessing an NGC system from the central
computer, contact your system or network administrator and verify the network
configuration, routing, firewall, and antivirus settings are correct. See Appendix A,
Troubleshooting Shared Database Connection Issues for more information.
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Chapter 3 Preparing the Central Computer and NGC Systems
The workflow for activating Security Edition on the central computer consists of the
following tasks. This chapter explains these tasks in detail.
4. Create ChromLab users on the central computer and assign access levels to NGC
systems.
Important: In order to use ChromLab after Security Edition has been activated on the
remote computers, users must log in to the shared database. This requires each user
to have a valid user name and password. You must create users after you activate
Security Edition on the central computer. For more information, see Chapter 9, Setting
Up ChromLab Users and Roles.
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Chapter 4 Activating Security Edition on the Central Computer
Note: Even if you are installing ChromLab for the first time, the system backs up the
empty NGC database. A new, empty NGC database requires approximately 75 MB of
free disk space.
Perform this task on all computers on which you plan to activate Security Edition.
a. Navigate to C:\ProgramData\Bio-Rad\NGC\Database.
Ensure that the disk on which you plan to save the backup zip file (the target disk) has
free disk space that is at least equal to the size of the NGC database.
2. On the backup computer, right-click the target folder and select New > Folder.
Note: You cannot activate Security Edition while either ChromLab software or the
NGC system is in use. Close ChromLab and shut down the system before launching
ChromLab Administration.
Important: You will perform this task on each remote ChromLab computer as well as
the central ChromLab computer. Ensure that the Administrator password for each
ChromLab computer is unique. Keep the Administrator passwords for all ChromLab
computers in a secure place.
2. Type the word admin for both the user name and password and click Login.
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Chapter 4 Activating Security Edition on the Central Computer
3. Type a new password for the ChromLab administrator in the Password field, type it
again in the Confirm Password field, and click Change.
Activating Security Edition requires a license key. This key is located on the back of your
Security Edition installation package.
When you activate Security Edition, the system prompts you to select a database location.
This section explains how to activate Security Edition on the central computer and
designate its database as the shared database.
1. On the Start menu, select ChromLab > ChromLab Administration and log in as the
ChromLab administrator.
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Chapter 4 Activating Security Edition on the Central Computer
2. Select ChromLab Security Edition from the Select mode to activate dropdown list.
3. In the License Key field, type the 18-character Security Edition license key and click
Apply.
5. In the Browse For Folder dialog box, select the NGC backup folder that you created
and click OK to create and save the NGC backup (.sbk) file.
When the backup completes, the Select Database Location dialog box appears.
6. In the Select Database Location dialog box, select Designate this computer as the
shared database host.
8. Click Activate Security Edition to establish the shared database on this computer.
A message informs you that changing the database to sharing mode requires
ChromLab to shut down. ChromLab connects to the shared database when you restart
the application.
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Chapter 4 Activating Security Edition on the Central Computer
ChromLab Administration closes. The next time it is started, ChromLab connects to the
shared database on this computer.
Next Steps
After you activate Security Edition on the central computer and before you connect the
remote computers to the shared database, Bio-Rad recommends that you create users and
assign the relevant roles. Afterwards, you can uninstall ChromLab software from the central
computer.
Creating Users
Important: In order to use ChromLab after Security Edition has been activated on the
remote computers, users must log in to the shared database. This requires each user
to have a valid user name and password. If you have not yet done so, Bio-Rad
suggests that you create users before activating Security Edition on the remote
computers.
For more information about creating and managing ChromLab user accounts, see Chapter
9, Setting Up ChromLab Users and Roles.
After you activate Security Edition on the central computer, and have created users and
assigned roles to them, you can uninstall ChromLab software from the central computer.
Although uninstalling removes ChromLab software and ChromLab Administration from the
computer, the ChromLab database remains and remote ChromLab computers and NGC
systems can access it.
Special Considerations
Uninstalling ChromLab from the central computer removes the Bio-Rad firewall settings
and the backup and restore feature in ChromLab Administration. This section lists two
important considerations to keep in mind if you choose to uninstall ChromLab software
from the central computer.
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Chapter 4 Activating Security Edition on the Central Computer
You must create the following custom inbound firewall rules in order for the SQL Browser
and SQL Server services to receive data from the network:
You will not be able to use ChromLab Administration to back up and restore the NGC
database. You must use SQL Server Management Studio or a 3rd party tool to back up and
restore the database. You require the password for the sa user to connect to the NGC
instance and perform this task.
Tip: You can also reinstall the same version of ChromLab software on the central
computer at any time to access ChromLab Administration and perform backup and
restore functions.
The workflow for connecting remote ChromLab computers to the shared database consists
of the following tasks. This chapter explains these tasks in detail.
2. (Optional but recommended) Export existing 6.1 ChromLab methods from all
computers.
Note: Only ChromLab methods can be imported into the Security Edition
database. See Importing Electronic Data Files on page 62 for more information.
See Locating the Date and Time Settings on ChromLab Computers on page 36.
See Activating ChromLab Software Security Edition on Remote Computers on page 41.
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Chapter 5 Connecting Remote Computers to the Central Computer
Important: In order to use ChromLab after Security Edition has been activated on the
remote computers, users must log in to the shared database. This requires each user
to have a valid user name and password. If you have not yet done so, Bio-Rad
suggests that you create users at this time. For more information about creating and
managing ChromLab user accounts, see Chapter 9, Setting Up ChromLab Users and
Roles.
Perform this task on the central ChromLab computer first. Verify that the settings on the
remote computers are the same as those on the central computer.
1. On the central ChromLab computer, open the Control Panel and select Date and Time.
2. In the Date and Time dialog box, note the current date, time, and time zone settings.
3. Close the Date and Time dialog box on the central computer.
4. On each remote computer, open the Date and Time dialog box.
n If the time zone is different from that on the central computer, click Change time
zone and modify the settings as necessary.
n If the date or time differ from those on the central computer, click Change date and
time and modify the settings as necessary.
Note: Even if you are installing ChromLab for the first time, the system backs up the
empty NGC database. A new, empty NGC database requires approximately 75 MB of
free disk space.
Perform this task on all computers on which you plan to activate Security Edition.
a. Navigate to C:\ProgramData\Bio-Rad\NGC\Database.
Ensure that the disk on which you plan to save the backup zip file (the target disk) has
free disk space that is at least equal to the size of the NGC database.
2. On the backup computer, right-click the target folder and select New > Folder.
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Chapter 5 Connecting Remote Computers to the Central Computer
Note: You can import only methods into Security Edition. You cannot import
associated runs with the methods into Security Edition. For more information, see
Importing Electronic Data Files on page 62
1. Start ChromLab.
2. Select File > Browse to open the Browse Data dialog box.
4. Select the project that contains the target file in the Projects pane.
5. Right-click the file or files to export in the right pane and select Export <file_type>.
The Exporting NGC Files dialog box appears, showing the status of the export. When
the export is complete, Completed appears in the Status column.
Note: You cannot activate Security Edition while either ChromLab software or the
NGC system is in use. Close ChromLab and shut down the system before launching
ChromLab Administration.
Important: You will perform this task on each remote ChromLab computer as well as
the central ChromLab computer. Ensure that the Administrator password for each
ChromLab computer is unique. Keep the Administrator passwords for all ChromLab
computers in a secure place.
2. Type the word admin for both the user name and password and click Login.
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Chapter 5 Connecting Remote Computers to the Central Computer
3. Type a new password for the ChromLab administrator in the Password field, type it
again in the Confirm Password field, and click Change.
Perform this task on all remote computers that will access the shared database. This
includes
n ChromLab workstations
1. On the Start menu, select ChromLab > ChromLab Administration and log in as the
ChromLab administrator.
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Chapter 5 Connecting Remote Computers to the Central Computer
2. Select ChromLab Security Edition from the Select mode to activate dropdown list.
3. In the License Key field, type the 18-character ChromLab Security Edition license key
and click Apply.
5. In the Browse For Folder dialog box, select the NGC backup folder that you created
and click OK to create and save the NGC backup (.sbk) file.
When the backup completes, the Select Database Location dialog box appears.
6. In the Select Database Location dialog box, select Remote shared database.
Tip: Select Local database only if you want to save data to the local ChromLab
database.
7. If it does not automatically appear, select the name or IP address of the central
computer in the dropdown list. Alternatively, type the central computer’s name or IP
address in the dropdown list box.
Important: You must use the same connection parameter for all remote
computers that will access the shared database. That is, all remote computers
should connect to the central computer using either its IP address or its computer
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Chapter 5 Connecting Remote Computers to the Central Computer
name. Bio-Rad strongly recommends that you connect to the central computer
using a static IP address.
A message informs you that changing the database to sharing mode requires
ChromLab to shut down. ChromLab connects to the shared database when you restart
the application.
ChromLab Administration closes. The next time it is started, ChromLab connects to the
shared database on the central computer.
Important: Until the ChromLab administrator has created users on the central
ChromLab computer, you will not be able to log in to ChromLab. Ensure that you have
a valid user name and password before performing this task.
3. Click Select.
n Choose a destination project for the method and click Select Project.
5. In the Import NGC File dialog box, click Browse to display the Open dialog box.
7. (Optional) In the Name box, type another name for the file.
Note: This option is available only when you select a file to import.
8. Click Import. During the import a status dialog box appears. When all methods have
successfully imported, the status displays Completed.
For more information about exporting and importing ChromLab data, see the NGC
Chromatography Systems and ChromLab Software User Guide.
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Chapter 5 Connecting Remote Computers to the Central Computer
Important: The rules in Table 2 are valid for unsigned objects only (signed objects
cannot be changed). As well, users must have the required permissions. For example,
only users assigned the Advanced User or Service User role can change unsigned
methods.
Tip: Remote users can log in to an NGC system while another user’s run is in
progress. However, only users assigned the Advanced User role can control an NGC
system that is in use by another user. Other users must wait until the run completes
before they can control the NGC system. As well, the run queue must be cleared of
pending runs before other users can control the NGC system. For more information
about controlling the NGC system, see Appendix 8, Connecting Multiple ChromLab
Computers to One NGC System.
Action Rule
Methods
Add a method to a project that contains another method Users are prompted to save the
with the same name method with a unique name before
saving it to the project.
Action Rule
Edit and save the same method at the same time Changes made by the first user are
(parallel editing) saved. The next user is prompted to
do one:
n Refresh the method then save
n Save the method with another
name
n Cancel and discard the changes
Edit and save the same method at different times Changes made by all users are
(sequential editing) saved.
Edit a method that was recently deleted by another user The original method is deleted. The
next user is prompted to do one:
n Save the method with another
name
n Cancel and discard the changes
Edit a method that was signed by another user The action fails. The system dis-
plays notification that the signed
method cannot be changed.
Run the same method on different systems at the same The method is queued and run in
time parallel.
Method Templates
Add a method template to the database if another Users are prompted to save the
template with the same name exists template with a unique name before
saving.
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Chapter 5 Connecting Remote Computers to the Central Computer
Action Rule
Edit and save the same template at the same time Changes made by the first user are
(parallel editing) saved. The next user is prompted to
do one:
n Refresh the template then save
n Save the template with another
name
n Cancel and discard the changes
Edit and save the same template at different times Changes made by all users are
(sequential editing) saved.
Edit a template that was recently deleted by another The original template is deleted.
user The next user is prompted to do
one:
n Save the method with another
name
n Cancel and discard the changes
Runs
Save a run to the database if another run with the same Users are prompted to save the run
name exists with a unique name before saving it
to the project.
Edit the same run at the same time (parallel editing) Changes made by the first user are
saved. The next user is informed
the run was changed and the run is
reloaded with the changes made.
Action Rule
Edit and save the same run at different times Changes made by all users are
(sequential editing) saved.
Edit a run that was recently deleted by another user The run is deleted. The next user is
informed the run was deleted and
the window closes.
Edit a run that was signed by another user The action fails. The system
displays notification that the signed
run cannot be changed.
Analyses
Save an analysis to the database if another analysis Users are prompted to save the
with the same name exists analysis with a unique name before
saving it to the project.
Edit and save the same analysis at the same time Changes made by the first user are
(parallel editing) saved. The next user is prompted to
do one:
n Save the analysis with another
name
n Cancel and discard the changes
Edit and save the same analysis at different times Changes made by all users are
(sequential editing) saved.
Edit an analysis that was signed by another user The action fails. The system
displays notification that the signed
analysis cannot be changed.
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Chapter 5 Connecting Remote Computers to the Central Computer
Action Rule
Delete an analysis if another user has it open The original analysis is deleted.
The next user is prompted to do
one:
n Save the analysis with another
name
n Cancel and discard the changes
Fluidic Schemes
Delete a fluidic scheme that was used in a method run The user is informed that the fluidic
by another user scheme is in use and cannot be
deleted.
Select or delete a fluidic scheme that was recently The original fluidic scheme is
deleted by another user deleted. The next user is prompted
Create a new fluidic scheme based on a scheme that to do one:
was recently deleted by another user n Save the fluidic scheme with
another name
n Cancel and discard the changes
Each workspace and the NGC instrument touch screen are shown and described in detail
in the NGC Chromatography Systems and ChromLab Software User Guide.
ChromLab Administration, the Home window, and the additional Security menu item are
shown and described in this chapter.
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Chapter 6 The Security Edition Workspace
ChromLab Administration
When ChromLab Administration is launched after Security Edition is activated, it opens
displaying the User Administration tab. The application also displays the Licensing,
Backup and Restore, and Database Location tabs.
The Licensing, Database Location, and Backup and Restore tabs are available to users
with the Administrator role. The User Administration tab is available to all users.
Menu Commands
Each tab has the same menu commands. This section explains the menu commands for
ChromLab Administration.
Show Inactive Users — displays currently active and deactivated Security Edition users.
Password Options — displays the Password Options dialog box. See Setting Password
Options on page 93 for more information.
Note: This option is enabled only for users with the Administrator role.
Show Audit Log — displays the System and User Administration Audit Log.
Note: This option is enabled only for users with the Administrator role.
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Chapter 6 The Security Edition Workspace
When Security Edition is activated, a lock and the name of the logged in user is displayed
in the left corner of the status bar. The status of connection to the NGC instrument is also
displayed. Links to recently completed runs, recently created methods, and recently
accessed or analyzed runs and analyses appear listed at the bottom of the window.
Tip: A controlled or signed file is identified by a specific icon beside its name, while an
uncontrolled file does not have an icon. Table 3 on page 59 shows the icons that
identify the status of data files. See Using ChromLab Software Security Edition on
page 57 for detailed information about uncontrolled, controlled, and signed files.
Home Window
General Audit Log — displays the General Audit Log.
Note: Only users assigned the Reviewer attribute can sign methods.
Evaluation Window
General Audit Log — displays the General Audit Log.
Show Run Audit Log — displays the audit log for the displayed run.
Note: Only users assigned the Reviewer attribute can sign runs.
Show Analysis Audit Log — displays the audit log for the displayed analysis.
Note: Only users assigned the Reviewer attribute can sign analyses.
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Chapter 6 The Security Edition Workspace
n Methods
n Runs
n Analyses
Security Edition data files are either uncontrolled, controlled, or signed. This section
defines these terms.
n Imported methods
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Chapter 7 Using ChromLab Software Security Edition
n Manual runs
n Scout runs
Uncontrolled methods remain uncontrolled until they are signed. At that time, they are
considered signed data files. Uncontrolled runs and analyses cannot be signed and
remain uncontrolled. Uncontrolled data files can be modified and saved without
restrictions.
Actions performed on a controlled file are tracked in its audit log. Controlled files can be
modified. Saving modified controlled files overwrites the original file, and the saved file is
controlled.
n Uncontrolled methods
n Controlled runs
n Controlled analyses
Signed files are read-only. They cannot be overwritten or deleted. Signed runs and
analyses can be opened and reviewed, and copies can be saved as a new controlled file
using the File > Save As dialog box. The changes are tracked in the audit log.
Uncontrolled file
Controlled file
Signed file
Note: You cannot sign an uncontrolled method that has associated uncontrolled
runs. You must save the method with a new name to sign it.
n Controlled runs
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Chapter 7 Using ChromLab Software Security Edition
Note: You cannot sign a run that was created from an uncontrolled, unsigned
method. You must save the method with a new name and sign the new method.
Use the signed method to create a signable run.
To sign a file
2. Choose Security > Sign <file>. The signing dialog box appears.
3. (Optional) In the Notes text box, include information about the file or a reason for
signing. This information is included in the audit log.
4. Enter the username and password of a user with the Reviewer attribute.
The username, date, and time of the signature are always included in the audit log (for
more information see Audit Logs on page 64).
5. If you manually edited the method during the run, you must provide a reason for each
change before you can sign the run.
b. For each manual edit, click the ellipses button beside the highlighted Reason field
to open the Add Reason dialog box.
6. Click Sign.
The file is saved in the project with the name shown in the signing dialog box.
2. Choose Security > Sign <file>. The re-signing dialog box appears.
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Chapter 7 Using ChromLab Software Security Edition
3. (Optional) In the Notes text box, include comments about the file or a reason for re-
signing.
4. Enter the username and password of a user with the Reviewer attribute.
5. (Optional) Click View Audit Log to see the audit log for this data file.
6. Click Sign.
Security Edition stores all data (for example, methods, templates, and runs) in a database
using Microsoft SQL Server. Bio-Rad highly recommends backing up this database
regularly. Backing up the database on a different drive from the one on which Security
Edition is running is also recommended.
The backup procedure saves the Security Edition database as a zip (.sbk) file. The .sbk file
is approximately the same size as the NGC database itself. Backing up and restoring the
database requires the same amount of free disk space as the size of the .sbk file.
Use ChromLab Administration to back up and restore the Security Edition database.
ChromLab Administration backs up all NGC data, including all methods, runs, analyses,
and audit logs. You can also use ChromLab Administration to set a reminder to back up the
NGC database on a daily, weekly, or monthly basis. The reminder appears on the
ChromLab computer.
Restoring the Security Edition database overwrites the current database. If you have saved
any new data since the backup, consider restoring the database onto another computer
running Security Edition in order to prevent data loss.
Each time a secure document is modified, you must provide a reason for each change
before you can sign the document. The modifications are logged in the document log. The
new signed document takes with it the entire history of the original document in its log.
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Chapter 7 Using ChromLab Software Security Edition
Audit Logs
Any changes made to or actions performed on a controlled run or a controlled analysis are
saved to the database and captured in an audit log. Audit logs are created when Security
Edition is activated. ChromLab Software, Security Edition has three audit logs:
n General audit log — captures user administration events, system and calibration
events, and information about changes made to or actions performed on a method,
run, or analysis.
n Run audit log — captures all major actions and changes for a single run.
n Analysis audit log — captures all major actions and changes for a single run or
multiple-run analysis.
This section details the events that are captured in the audit logs.
n Manual runs
n Scout runs
n Annotations
n Chromatogram settings
n System pumps
n Sample pumps
n Conductivity monitor
n pH probe
o Changes to
n (In a multiple NGC system environment) User taking control of the NGC
system
Note: All system events are captured in the general audit log. All events started
from the touch screen are captured in the general audit log while the connection
to the ChromLab computer is active. If the connection is inactive, you are notified
when you attempt to make changes from the touch screen. System events are
logged to the user logged into the ChromLab computer.
o Adding/modifying/deleting users
o Activating/deactivating users
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Chapter 7 Using ChromLab Software Security Edition
n Run start
Note: You can change injection points only for controlled unsigned runs. You
cannot change an injection point when the run has been signed. You must
provide a reason for setting the injection point in the Set Injection Point dialog box
before you can click Apply. The reason is included in the audit log.
o Zero baseline
o Pause/resume run
o Stop/start run
o Hold step
Note: Manual edits to method runs are logged to the user logged into the
ChromLab computer. You must provide a reason for each manual edit in the run’s
audit log before you can sign the run.
n Run completion
o Participating traces
o Integration parameters
o Trace deletions
o Peak deletions
o Peak deletions
o Peak splits
o Peak additions
n Undo/redo actions
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Chapter 7 Using ChromLab Software Security Edition
Note: You can change injection points only for controlled unsigned analyses. You
cannot change an injection point when the analysis has been signed. You must
provide a reason for setting the injection point in the Set Injection Point dialog box
before you can click Apply. The reason is included in the audit log.
n Multiple-run analysis
n Date and time — the local date and time when the event occurred.
n Username — the username of the logged in user when the event occurred.
n Event type — the type of event, for example run, analysis, calibration, user
administration.
n System name — the NGC system on which the method was run.
Tip: Until the data file is signed, you can edit this text box. After the file is signed
this box is no longer editable.
In addition, the following fields are displayed in the general and analysis audit logs:
n File name — the name of the method, run, or analysis acted upon.
n Project name — the name of the project folder in which the object is located.
u Select Security > General Audit Log. The audit log appears.
By default, the data are sorted by date and time, and the event column displays the full
description of the events. You can filter the data by date, username, event type, and
text string. You can sort the data by any column, and you can set the event column to
display a general description of the events.
1. By default, the audit log displays all events performed by all users within the past 30
days. In the Date section, choose the date range of events to view.
2. In the Username section, clear the checkboxes of the users whose events you do not
want to include in the filtered view.
3. In the Event Type section, clear the checkboxes of the events you do not want to
include in the filtered view.
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Chapter 7 Using ChromLab Software Security Edition
4. In the Text section, type a word or phrase to include in the filtered view.
u Click the heading of the data column you want to sort to perform an ascending sort (A
to Z, smallest number to largest, or earliest to most recent).
u Select the Show full event description checkbox at the bottom of the dialog box.
u Click Create Report. A report similar to a method, run, or analysis report appears.
Tip: The general audit log report includes all information displayed on the screen.
If you filtered the data, only the results of the filter are printed.
u In the open run, select Security > Run Audit Log. The run audit log appears.
2. Select Security > Analysis Audit Log. The analysis audit log appears.
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Chapter 7 Using ChromLab Software Security Edition
Signed Reports
The three report formats available in Security Edition make it easy to publish signed
method, run, and analysis data in detailed reports. Although only users with the Reviewer
attribute can sign reports, all users can view them.
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Chapter 7 Using ChromLab Software Security Edition
n Event description — the details of each event including any changes to the method.
In ChromLab Software, Security Edition users assigned the Advanced User role can take
control of the NGC system and override another user’s control of an instrument. This is
useful in the event that the controlling computer is locked or the user performing the run is
not available and there is an immediate need to stop the instrument.
n Users assigned the Advanced User role have Take Control access to all NGC
systems. You cannot change this access level for these users.
n The first user connecting to an NGC system from a ChromLab computer has full control
of the instrument. The first user’s computer retains control until a user assigned the
Advanced User role overrides the instrument.
n In a shared database environment a user can take control any time except during
system calibration or a Point-to-Plumb operation. Unsaved data from manual runs or
current runs are saved to the shared database.
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Appendix 8 Connecting Multiple ChromLab Computers to One NGC System
n In a standard environment (one in which each ChromLab computer saves data to its
own database), a user cannot take control if any of the following conditions are true:
Note: Only users assigned the Advanced User role can perform this task. Take Control
is disabled during system calibration or Point-to-Plumb actions.
1. If you have not already done so, connect to the target NGC system.
If successful, ChromLab displays a message informing you that you have control of the
system. ChromLab displays a relevant message to the user who lost control.
This chapter explains how to set up and manage ChromLab user accounts and roles.
Note:
n User accounts can have any name or password. See the section Setting Password
Options in Security Edition on page 93 for information about setting password rules for
maximum security.
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Chapter 9 Setting Up ChromLab Users and Roles
Advanced User This role is designed for users requiring full access to
all Security Edition functionality.
Reviewer Attribute
Users assigned the Reviewer attribute can sign secure methods, runs, and analyses. The
Reviewer attribute can be assigned to any user with the Advanced User or User role. The
attribute is not available to users with the Administrator or Service User role.
Role Permissions
Roles determine which features in Security Edition users can access. If a user attempts to
perform an action that is not permitted for the assigned role, ChromLab displays an error
message. In some instances the user’s role determines which Security Edition features are
available and/or enabled. Not all features will be available to all users.
Important: Users cannot be assigned multiple roles. Review the permissions carefully
before assigning roles.
Table 5 lists the Security Edition functions that each role has permission to perform. See
Using ChromLab Software Security Edition on page 57 for detailed information about
uncontrolled, controlled, and signed files.
Advanced Service
Administrator User User User
General
* Administrators can see and edit only the ChromLab Administration details in the general audit
log.
Methods
Create new X X
uncontrolled methods
View (open) X X X
uncontrolled methods
Import uncontrolled X X
methods
Modify (save) X X
methods
Run uncontrolled X X X
methods
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Chapter 9 Setting Up ChromLab Users and Roles
Advanced Service
Administrator User User User
Delete uncontrolled X X
methods
Delete signed
methods
Rename uncontrolled X X
methods
Rename signed
methods
Method Templates
View (open) X X X
templates
Modify (save) X X
templates
Delete user-defined X X
templates
Rename templates X X
Advanced Service
Administrator User User User
System Control
Run manually X X X
Run uncontrolled X X X
methods
Change fluidic X X X
scheme
Calibrate NGC X X X
system
Modify system X X
settings
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Chapter 9 Setting Up ChromLab Users and Roles
Advanced Service
Administrator User User User
Runs
Open (view) X X X
uncontrolled runs
from an uncontrolled
method
Open (view) X X
controlled runs from a
signed method
Modify controlled X X
runs from a signed
method (injection
point)
Advanced Service
Administrator User User User
Rename uncontrolled X X X
runs from an
uncontrolled method
Rename controlled X X
runs
Delete uncontrolled X X X
runs including:
n Column
performance runs
n Scout runs
n Manual runs
n Runs based on
uncontrolled
methods
Import runs
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Chapter 9 Setting Up ChromLab Users and Roles
Advanced Service
Administrator User User User
Analyses
Create analyses X X X
View uncontrolled X X X
analyses
View controlled X X
analyses
Modify uncontrolled X X X
analyses
Modify controlled X X
analyses
Modify signed
analyses
Rename uncontrolled X X X
analyses
Rename controlled X X
analyses
Rename signed
analyses
Delete uncontrolled X X X
analyses
Advanced Service
Administrator User User User
Delete controlled X
analyses
Delete signed
analyses
Copy controlled X X
analyses
Copy signed X X
analyses
ChromLab
Administration
n Add users X
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Chapter 9 Setting Up ChromLab Users and Roles
Advanced Service
Administrator User User User
n Delete users X
n Enable/disable X
users
n Change all X
passwords
Important: The admin user account is the default Administrator account, which you
use to initially log into ChromLab Administration. To comply with 21 CFR Part 11, it is
strongly recommended that you create a user account to administer Security Edition.
Assign this account the Administrator role and perform all Security Edition
administration tasks with this account. Do not use the default admin user account to
perform activities other than to log in and create this first account.
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Chapter 9 Setting Up ChromLab Users and Roles
1. On the Start menu, select ChromLab > ChromLab Administration and log in as a
ChromLab administrator. ChromLab Administration opens, displaying the User
Administration tab.
Note: Information provided in the first name, last name, and username boxes
cannot include the following characters:
"/\[]:;|=,+*?<>
Bio-Rad recommends entering the user’s actual full name, because this name
appears in the event logs as required by 21 CFR 11.50a.
n Email address
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Chapter 9 Setting Up ChromLab Users and Roles
n Phone number
n Location
n Active — by default, all user accounts are active when first created. Clear this
checkbox to remove a user’s access to ChromLab.
n Administrator — by default, user accounts are not assigned the administrator role
when first created. Select this checkbox to assign this role to the user.
n Click Cancel to close the Add User dialog box without saving the user account to
the ChromLab database.
5. Create additional user accounts for each ChromLab user at your site.
1. On the Start menu, select ChromLab > ChromLab Administration and log in as a
ChromLab administrator.
2. From the list of user accounts in the left pane in the User Administration dialog box,
select the user account to modify.
n Click Cancel to close the Edit User dialog box without saving the changes.
Note: If you clear the Active checkbox to deactivate a current user account, the
following message appears:
5. Click Yes to continue or No to cancel the action and close the dialog box.
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Chapter 9 Setting Up ChromLab Users and Roles
1. On the Start menu, select ChromLab > ChromLab Administration and log in as a
ChromLab administrator.
2. From the list of user accounts in the User Administration dialog box, select the user
account to delete.
1. On the Start menu, select ChromLab > ChromLab Administration and log in as a
ChromLab administrator.
2. Select View > Password Options. The Password Options dialog box appears.
n Require upper case — the password requires at least one upper case letter.
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Chapter 9 Setting Up ChromLab Users and Roles
! [
@ ]
% \
& ?
* /
( :
) ;
{ _ (underscore)
} - (hyphen)
. (dot)
The default is five characters. You can increase or decrease the value.
n Maximum failed login attempts — the user can try the specified number of times
to log in to the account with this password.
The default is ten attempts. You can increase or decrease the value.
Note: If the user fails to successfully log in within the specified number of
attempts, the account is locked. A message informs the user to contact the
ChromLab administrator to reset the password.
5. Click OK to save the password settings and close the dialog box.
3. Click Login.
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Chapter 9 Setting Up ChromLab Users and Roles
Important: Bio-Rad strongly recommends that you regularly back up the shared
ChromLab database and save the backup file in a safe location. For more information
about backing up the ChromLab database, see the chapter Database Maintenance in
the NGC Chromatography Systems and ChromLab Software User Guide.
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Appendix A Troubleshooting Shared Database Connection Issues
Table 6. Possible causes and solutions for shared database connection issues
NGC database service is not n Restart the database service on the central computer.
started See Restarting the NGC Database Service on page 101.
NGC database service fails to n Uninstall and then reinstall ChromLab on the central
start computer.
See the NGC Chromatography Systems and ChromLab
Software Installation Guide for specific information.
Network connection fails n Your site’s DNS server might be down. If you
connected to the central computer using its computer
name, change the connection parameters to use its IP
address.
See Changing the Connection Parameters to the Central
Computer on page 104.
Table 6. Possible causes and solutions for shared database connection issues,
continued
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Appendix A Troubleshooting Shared Database Connection Issues
a. On the central computer, right-click the computer’s desktop icon and select
Properties.
b. Locate and note the computer name and full computer name.
n Connect to the central computer with the new settings you noted in Steps 1–2.
5. On each remote computer, start ChromLab Administration and reconnect to the central
computer.
For more information, see Chapter 5, Connecting Remote Computers to the Central
Computer.
1. On the central computer’s desktop, right-click the computer’s desktop icon and select
Manage.
2. In the Computer Management dialog box, expand Services and Applications in the left
pane and select Services.
1. On the central computer, uninstall ChromLab first and then uninstall Microsoft
SQL Server:
d. In the list of installed programs, locate and uninstall Microsoft SQL Server.
2. When the uninstallation is complete, locate and rename the NGC database folder.
Tip: The ChromLab software installer detects that SQL Server is not installed and
installs the application.
4. Activate Security Edition and designate the new database as the shared database.
For more information, see Activating Security Edition on the Central Computer on page
29.
5. If you regularly backed up the original database, restore the data into the new
database.
n If you changed the name of the ChromLab central computer or its IP address, go
to Step 7.
7. On all remote computers, start ChromLab Administration and select the Database
Location tab.
9. Start ChromLab on the remote computers and verify connection to the shared
database.
Tip: Skip Step 1 if you know the IP address of the central computer.
For more information about locating the IP address of a computer, see your
system or network administrator.
2. On each remote computer, open a command prompt window and ping the central
computer. For example:
The central computer responds to the ping request if it is available on the network.
Note: See your system or network administrator if the central computer fails to
respond to the ping request.
3. On each remote computer, start ChromLab Administration and select the Database
Location tab.
4. In the Remote Shared Database dropdown list, select the IP address of the central
computer.
5. Click Connect.
Publishes data about SQL Server and is used during initial connection to the database
Table 7 lists the required firewall settings for these rules. Ensure that your firewall tool
follows these rules for the NGC database on the central ChromLab computer or server.
Remote
Rule Program Protocol Local Port Port
Bio-Rad NGC SQLServer Any Any Any Any
NG
Note: Bio-Rad recommends that you set up the shared database on a new computer
and connect your existing ChromLab computers to the new database.
2. Verify the site requirements for the See the NGC Chromatography Systems and
central computer. ChromLab Software Installation Guide.
3. Verify the central computer meets the See System Requirements on page 13.
system requirements.
5. Prepare the ChromLab central See Preparing the Central Computer and
computer and NGC systems. NGC Systems on page 15.
5. Create ChromLab users and Central computer See Next Steps on page
assign roles 33.
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