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ChromLab Security Edition

The ChromLab Software Security Edition User Guide (Version 6.1) provides comprehensive instructions for installing, configuring, and utilizing the ChromLab software in compliance with U.S. FDA regulations. It covers preparation for sharing the ChromLab database, activating the Security Edition, and managing users and roles, along with troubleshooting and system requirements. Technical support information and guidelines for ensuring compliance with 21 CFR Part 11 are also included.

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0% found this document useful (0 votes)
22 views114 pages

ChromLab Security Edition

The ChromLab Software Security Edition User Guide (Version 6.1) provides comprehensive instructions for installing, configuring, and utilizing the ChromLab software in compliance with U.S. FDA regulations. It covers preparation for sharing the ChromLab database, activating the Security Edition, and managing users and roles, along with troubleshooting and system requirements. Technical support information and guidelines for ensuring compliance with 21 CFR Part 11 are also included.

Uploaded by

humeyrakaradoruk
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 114

6.

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
No part of this publication may be reproduced or transmitted in any form or by any means,
electronic or mechanical, including photocopy, recording, or any information storage or
retrieval system, without permission in writing from Bio-Rad.
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

Chapter 2 Preparing to Share the ChromLab Database 9


Preparing Your Site 12
Site Requirements 12
System Requirements 13

Chapter 3 Preparing the Central Computer and NGC Systems 15


Preparing the Central Computer and NGC Systems 16
Backing Up and Restoring ChromLab Data to the Central Computer 17
Setting a Static IP Address on Each NGC System 20
Verifying Each NGC System Name Is Unique 22
Verifying that All NGC Systems Can Reach the Central Computer 23

Chapter 4 Activating Security Edition on the Central Computer 25


Creating an NGC Database Backup Folder 26
Changing the ChromLab Default Password 27
Activating Security Edition on the Central Computer 29
Next Steps 33
Creating Users 33
Uninstalling ChromLab Software on the Central Computer 33

User Guide | iii


Table of Contents

Chapter 5 Connecting Remote Computers to the Central Computer 35


Locating the Date and Time Settings on ChromLab Computers 36
Creating an NGC Database Backup Folder 37
Exporting Existing ChromLab Data 38
Changing the ChromLab Default Password 39
Activating ChromLab Software Security Edition on Remote Computers 41
Importing Existing ChromLab Data 44
Rules for Sharing ChromLab Data 46

Chapter 6 The Security Edition Workspace 51


ChromLab Administration 52
Menu Commands 52
The Security Edition Home Window 54
Security Edition Menu Commands 55
Home Window 55
System Control Window 55
Method Editor Window 55
Evaluation Window 55

Chapter 7 Using ChromLab Software Security Edition 57


Electronic Records 57
Uncontrolled Data Files 57
Controlled Data Files 58
Signed Data Files 58
Identifying Data File Status 59
Signing Data Files 59
Importing Electronic Data Files 62
Exporting Electronic Data Files 62
Backing Up and Restoring the Security Edition Database 63

iv | ChromLab Software, Security Edition


Table of Contents

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

Appendix 8 Connecting Multiple ChromLab Computers to One NGC


System 75
Rules for Managing Access to NGC Systems 75
Taking Control of an NGC System 76

Chapter 9 Setting Up ChromLab Users and Roles 77


Users and Roles 77
Reviewer Attribute 78
Role Permissions 78
Managing ChromLab User Accounts 87
Adding User Accounts 87
Editing a User Account 90
Deleting a User Account 92
Setting Password Options in Security Edition 93
Setting Password Options 93
Starting ChromLab Software Security Edition 95

Appendix A Troubleshooting Shared Database Connection Issues 97


Possible Causes for Shared Database Connection Issues 97
Solutions for Shared Database Connection Issues 100

User Guide | v
Table of Contents

Changing the Location Parameters of Shared Database 100


Restarting the NGC Database Service 101
Uninstalling Microsoft SQL Server on the Central ChromLab Computer 102
Changing the Connection Parameters to the Central Computer 104
Manually Adding Inbound Firewall Rules 105

Appendix B Configuration Checklists 107


Preparing Your Site 107
Setting Up the Shared Environment 109

vi | ChromLab Software, Security Edition


Chapter 1 Introduction
U.S. FDA 21 CFR Part 11 Compliance
ChromLab software, Security Edition enables ChromLab users to meet the Food and Drug
Administration’s regulations on good laboratory practices in the pharmaceutical and
biotechnology industries.

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.

n Bio-Rad makes no claim that ChromLab software, Security Edition is CFR-compliant in


and of itself, nor does the company guarantee compliance for the user. Your organization
must establish policies and standard operating procedures that work in conjunction with
the tools provided by Bio-Rad to ensure compliance with 21 CFR Part 11.

User Guide | 7
Chapter 1 Introduction

Finding Out More


After you install NGC Chromatography Systems and ChromLab Software documentation
from the NGC Chromatography Systems Software USB drive, you can access installed
NGC guides and tutorials on the Help menu in any ChromLab view.

More information about the NGC chromatography systems and ChromLab software is
available from the following sources.

n The NGC Chromatography Systems and ChromLab Software Installation Guide is


available on the NGC Chromatography Systems Software USB drive. This document
explains how to set up your environment, set up and install the NGC instrument in the
lab, and install ChromLab software and connect ChromLab to the NGC system.

n The NGC Chromatography Systems and ChromLab Software Instrument Guide is


available on the NGC Chromatography Systems Software USB drive. This document
details the modules that comprise the NGC instrument and includes information about
priming, plumbing, troubleshooting, and maintaining the NGC system.

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.

8 | ChromLab Software, Security Edition


Chapter 2 Preparing to Share the ChromLab
Database
You can install ChromLab software on a central computer on your local network and share
data among multiple users, ChromLab computers, and NGC systems.

The following diagram illustrates supported shared ChromLab database configurations.

User Guide | 9
Chapter 2 Preparing to Share the ChromLab Database

10 | ChromLab Software, Security Edition


In the shared environment, one installation of ChromLab software is designated as the host
of the shared database. The shared database can serve any of the following
configurations.

n Multiple ChromLab workstations

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.

n One NGC system connected to the central ChromLab computer

Data from the connected NGC system are saved to the shared database and are
accessible to users from any computer running ChromLab software.

n Multiple ChromLab computers and NGC systems

Computers running ChromLab software (known in this document as ChromLab


computers) and the NGC systems can access and use the shared database. Each
ChromLab computer can connect to any available NGC system on the network,
operate it, and save data to the shared database. Data from the NGC systems are also
saved to the shared database.

n Multiple ChromLab computers connected to one NGC system

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.

Important: Preventing unauthorized users from accessing the NGC system’s


touch screen is the responsibility of the customer.

User Guide | 11
Chapter 2 Preparing to Share the ChromLab Database

Preparing Your Site


Note: You can upgrade ChromLab software standard or Security Edition from version
3.x or higher to version 6.1. If you are running an earlier version of ChromLab
software, you must first upgrade to one of these versions before you can upgrade to
ChromLab 6.1.

Preparing your site to share a ChromLab database requires the following tasks:

1. Verify the site requirements for the central computer.

See the next section, Site Requirements.

2. Verify that the central computer meets the hardware and software requirements.

See System Requirements on page 13.

3. Install or upgrade ChromLab software on the central and remote computers.

For detailed instructions about installing or upgrading ChromLab software and


connecting to the NGC system, see the NGC Chromatography Systems and
ChromLab Software Installation Guide.

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.

12 | ChromLab Software, Security Edition


Preparing Your Site

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.

Table 1. Minimum system requirements for a shared ChromLab database

Hardware and Software Minimum Requirement


One of the following:
n Microsoft Windows 10 Pro (64-bit only)
n Microsoft Windows 10 Enterprise (64-bit only)
n Operating systemMicrosoft Windows Server 2012
R2
n Microsoft Windows Server 2016

Processor Intel Pentium IV with EM64T support or equivalent,


3.0 GHz minimum

RAM 8 GB

Hard disk space 500 GB minimum


Note: ChromLab installs Microsoft SQL Server 2014
Express. This application requires 6 GB of disk space.

File system NTFS (New Technology File System)

Optional peripherals USB 3.0 high speed ports (2 minimum)


(Required only if an NGC Mouse
system is connected to the
Keyboard
central computer.)
2 gigabit Ethernet port (1 minimum)

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.

User Guide | 13
Chapter 2 Preparing to Share the ChromLab Database

14 | ChromLab Software, Security Edition


Chapter 3 Preparing the Central Computer
and NGC Systems
To ensure that the NGC systems can successfully connect to the central ChromLab
computer, they all must have access to the subnet on which the central computer resides.

Important: If an NGC system is connected by an ethernet communication cable to a


ChromLab computer that is not the central computer, disconnect the cable from the
ChromLab computer and connect the NGC system to the network. See the NGC
Chromatography Systems and ChromLab Software Installation Guide for information
about connecting your NGC system to the network. Ensure the network can access the
subnet on which the central computer resides.

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.

n If installing on a Windows Server computer, ensure that it is dedicated to the


ChromLab installation. ChromLab requires and installs Microsoft SQL Server 2014
and is not supported on any other version of this software.

User Guide | 15
Chapter 3 Preparing the Central Computer and NGC Systems

Preparing the Central Computer and NGC Systems


Preparing the central computer and the NGC systems requires the following tasks. This
chapter explains these tasks in detail.

1. Install ChromLab software on the central computer and all remote computers and NGC
systems.

See NGC Chromatography Systems and ChromLab Software Installation Guide.

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.

3. Assign a static IP address to the central ChromLab computer.

See your system administrator for information about assigning a static IP address to
the central computer.

4. Verify or assign a unique system name to each NGC system.

See Verifying Each NGC System Name Is Unique on page 22.

5. Verify or assign a static IP address to each NGC system.

See Setting a Static IP Address on Each NGC System on page 20.

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.

16 | ChromLab Software, Security Edition


Preparing the Central Computer and NGC Systems

Backing Up and Restoring ChromLab Data to the Central


Computer
Bio-Rad recommends that you activate ChromLab Software, User Management Edition on
a clean computer (one that does not have ChromLab installed). After you install ChromLab
software on the clean computer and upgrade your existing ChromLab databases to version
6.1, use ChromLab Administration to back up your largest database and restore it onto the
central computer. You can also use ChromLab Administration to set a reminder to back up
the NGC database on a daily, weekly, or monthly basis.

Important: Restoring backup data overwrites existing ChromLab data. Perform this
task only once, and carefully select the database to back up and restore.

Backing Up ChromLab Data on the Remote Computer

Perform the backup procedure on the remote ChromLab computer.

To back up a ChromLab database

1. Verify that you have upgraded ChromLab to version 6.1.

2. On the remote computer, determine the size of the NGC database.

a. Navigate to C:\ProgramData\Bio-Rad\NGC\Database.

b. Right-click on the Database folder and select Properties.

c. On the General tab, note the Size value.

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.

4. In ChromLab Administration, select the Backup and Restore tab.

User Guide | 17
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.

7. When the backup completes, close ChromLab Administration.

Setting a Backup Reminder on the Remote Computer

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.

To set a reminder to back up the central database

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.

To stop receiving reminders to back up the database

u In the Backup Reminder section, clear the Set Reminder checkbox and click Apply.

18 | ChromLab Software, Security Edition


Preparing the Central Computer and NGC Systems

Restoring ChromLab Data to the Central Computer

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.

To restore ChromLab data to the central ChromLab computer

1. Verify that you have installed ChromLab 6.1 on the central computer.

2. On the Start menu, select ChromLab > ChromLab Administration.

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.

5. When the restore completes, close ChromLab Administration.

User Guide | 19
Chapter 3 Preparing the Central Computer and NGC Systems

Setting a Static IP Address on Each NGC System


Note: Bio-Rad strongly recommends that you set a static IP address on each NGC
system that connects to the central computer. Alternatively, you can record and use its
system name to verify its connection to the central computer.

Important: The NGC system must restart to apply the IP address changes.

To set a static IP address on the NGC system

1. On the instrument touch screen, select System Information on the dropdown menu.

The System Information dialog box appears.

2. In the General tab, click Configure beside System IP Address.

The Configure IP Address dialog box appears.

20 | ChromLab Software, Security Edition


Preparing the Central Computer and NGC Systems

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 IP address — the specific numeric address for the NGC system.

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.

A message appears explaining that the NGC system must restart.

5. Click Yes to save the changes and restart the system.

The NGC system shuts down and restarts.

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.

User Guide | 21
Chapter 3 Preparing the Central Computer and NGC Systems

Verifying Each NGC System Name Is Unique


Each NGC system that connects to the central ChromLab computer must have a unique
system name. Locate the NGC system’s name and, if necessary, change the name so that
it is unique.

To locate the NGC system name

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.

3. Close the System Information dialog box.

If two or more NGC systems have the same name, you must change one name so that
each is unique.

To change the NGC system name

1. On the instrument touch screen, select System Settings on the dropdown menu.

The System Settings dialog box appears.

2. Select the System Name tab.

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.

22 | ChromLab Software, Security Edition


Preparing the Central Computer and NGC Systems

Verifying that All NGC Systems Can Reach the Central


Computer
To verify that all NGC systems can reach the central computer

1. On the central ChromLab computer, open a command prompt window.

2. At the prompt, type

> ping <NGC_IP_address>

If the NGC systm can reach the central computer, a response similar to the following
appears:

Pinging <NGC_system_name>

Reply from <data from local IP Address> time<1ms

3. Perform Step 2 for each NGC system and remote computer you plan to connect to the
central computer.

4. Exit the command prompt window.

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.

User Guide | 23
Chapter 3 Preparing the Central Computer and NGC Systems

24 | ChromLab Software, Security Edition


Chapter 4 Activating Security Edition on the
Central Computer
When ChromLab is installed, by default it is set to run in standard mode (that is, only the
local database is available). It continues to run in this mode until a user with ChromLab
Administrator privileges activates ChromLab Software, Security Edition.

The workflow for activating Security Edition on the central computer consists of the
following tasks. This chapter explains these tasks in detail.

1. Create an NGC database backup folder on the central computer.

See Creating an NGC Database Backup Folder on page 37.

2. Change the default admin password in ChromLab Administration.

See Changing the ChromLab Default Password on page 39.

3. Activate Security Edition on the central computer.

See Activating Security Edition on the Central Computer on page 29.

4. Create ChromLab users on the central computer and assign access levels to NGC
systems.

See Next Steps on page 33.

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.

User Guide | 25
Chapter 4 Activating Security Edition on the Central Computer

Creating an NGC Database Backup Folder


ChromLab automatically backs up the existing NGC database when you activate Security
Edition. If you have not previously backed up your NGC database, consider creating the
database backup folder at this time.

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.

To create the NGC database backup folder

1. Determine the size of the NGC database.

a. Navigate to C:\ProgramData\Bio-Rad\NGC\Database.

b. Right-click the Database folder and select Properties.

c. On the General tab, note the Size value.

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.

3. Rename the new folder, for example, NGC Database Backup.

26 | ChromLab Software, Security Edition


Changing the ChromLab Default Password

Changing the ChromLab Default Password


You activate Security Edition through the ChromLab Administration tool. The first time you
launch ChromLab Administration on each computer you must change the default admin
password before continuing.

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.

To change the default admin password

1. On the Start menu, select ChromLab > ChromLab Administration.

The Login dialog box appears.

2. Type the word admin for both the user name and password and click Login.

User Guide | 27
Chapter 4 Activating Security Edition on the Central Computer

The Change Password dialog box appears.

3. Type a new password for the ChromLab administrator in the Password field, type it
again in the Confirm Password field, and click Change.

28 | ChromLab Software, Security Edition


Activating Security Edition on the Central Computer

Activating Security Edition on the Central Computer


Note: You cannot activate Security Edition while either ChromLab or the NGC system
are in use. Close ChromLab and shut down the system before launching ChromLab
Administration.

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.

Important: ChromLab automatically backs up the current NGC database, creates an


empty database, and then activates Security Edition. Depending on the size of your
current NGC database, this process can take some time.

To activate Security Edition on the central computer

1. On the Start menu, select ChromLab > ChromLab Administration and log in as the
ChromLab administrator.

User Guide | 29
Chapter 4 Activating Security Edition on the Central Computer

ChromLab Administration opens, displaying the Licensing tab.

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.

The Activating ChromLab Security Edition dialog box appears.

4. Click OK. The Browse For Folder dialog appears.

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.

30 | ChromLab Software, Security Edition


Activating Security Edition on the Central Computer

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.

7. (Optional) Click Test Connection.

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.

9. Click Yes to continue the connection process.

User Guide | 31
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.

32 | ChromLab Software, Security Edition


Next Steps

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.

Uninstalling ChromLab Software on the Central Computer


Note: This task is optional.

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.

User Guide | 33
Chapter 4 Activating Security Edition on the Central Computer

Creating Inbound Firewall Rules for the ChromLab Database

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:

n Bio-Rad NGC SQLServer NG

n Bio-Rad NGC SQLServer Browser

Important: Contact your system or network administrator or Bio-Rad Technical


Support for assistance. See Manually Adding Inbound Firewall Rules on page 105 for
more information.

Backing Up and Restoring ChromLab Data

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.

For more information, contact Bio-Rad Technical Support.

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.

34 | ChromLab Software, Security Edition


Chapter 5 Connecting Remote Computers to
the Central Computer
When ChromLab is installed, by default it is set to run in standard mode (that is, only the
local database is available). It continues to run in this mode until a user with ChromLab
Administrator privileges activates ChromLab Software, Security Edition.

The workflow for connecting remote ChromLab computers to the shared database consists
of the following tasks. This chapter explains these tasks in detail.

1. Verify that ChromLab 6.1 is installed on each remote computer.

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.

3. Verify date and location settings on the remote computers.

See Locating the Date and Time Settings on ChromLab Computers on page 36.

4. Create an NGC database backup folder on all remote ChromLab computers.

See Creating an NGC Database Backup Folder on page 37.

5. Change the local default admin password in ChromLab Administration.

See Changing the ChromLab Default Password on page 39.

6. Activate Security Edition on each remote computer.

See Activating ChromLab Software Security Edition on Remote Computers on page 41.

7. (Optional) Import existing data to the shared database.

User Guide | 35
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.

Locating the Date and Time Settings on ChromLab


Computers
In order for ChromLab to function correctly, the date and time settings on remote computers
must be the same as those on the central computer.

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.

To locate the date and time settings

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.

5. Note the date, time, and time zone settings.

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.

6. Close the Date and Time dialog box.

36 | ChromLab Software, Security Edition


Creating an NGC Database Backup Folder

Creating an NGC Database Backup Folder


ChromLab automatically backs up the existing NGC database when you activate Security
Edition. If you have not previously backed up your NGC database, consider creating the
database backup folder at this time.

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.

To create the NGC database backup folder

1. Determine the size of the NGC database.

a. Navigate to C:\ProgramData\Bio-Rad\NGC\Database.

b. Right-click the Database folder and select Properties.

c. On the General tab, note the Size value.

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.

3. Rename the new folder, for example, NGC Database Backup.

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Chapter 5 Connecting Remote Computers to the Central Computer

Exporting Existing ChromLab Data


Important: ChromLab creates a backup of the database that resides on the local
computer when you activate Security Edition. Because restoring the backup data
overwrites existing data, Bio-Rad strongly recommends that you export ChromLab
methods from the local ChromLab database that you want to use in the shared
environment. Perform this procedure after you upgrade to ChromLab 6.1 and before
you activate Security Edition on remote computers. You can then import the methods
into the shared database after you set up the shared environment. This ensures you
have access to all your necessary methods.

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

To export ChromLab methods

1. Start ChromLab.

2. Select File > Browse to open the Browse Data dialog box.

3. Choose Methods on the View by dropdown list.

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 Browse for Folder dialog box appears.

6. Browse to a target folder or create a destination folder and click OK.

The Exporting NGC Files dialog box appears, showing the status of the export. When
the export is complete, Completed appears in the Status column.

7. Click OK to close the dialog box.

38 | ChromLab Software, Security Edition


Changing the ChromLab Default Password

Changing the ChromLab Default Password


You activate Security Edition through the ChromLab Administration tool. The first time you
launch ChromLab Administration on each computer you must change the default admin
password before continuing.

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.

To change the default admin password

1. On the Start menu, select ChromLab > ChromLab Administration.

The Login dialog box appears.

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

The Change Password dialog box appears.

3. Type a new password for the ChromLab administrator in the Password field, type it
again in the Confirm Password field, and click Change.

40 | ChromLab Software, Security Edition


Activating ChromLab Software Security Edition on Remote Computers

Activating ChromLab Software Security Edition on


Remote Computers
Note: You cannot activate Security Edition while either ChromLab software or the
NGC system are in use. Close ChromLab and shut down the NGC system before
launching ChromLab Administration.

Perform this task on all remote computers that will access the shared database. This
includes

n ChromLab workstations

n ChromLab computers connected to NGC systems, including those in read-only mode

Important: ChromLab automatically backs up the current NGC database, creates an


empty database, and then activates Security Edition. Depending on the size of your
current NGC database, this process can take some time.

To activate Security Edition on remote computers

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

ChromLab Administration opens, displaying the Licensing tab.

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.

The Activating ChromLab Security Edition dialog box appears.

4. Click OK. The Browse For Folder dialog appears.

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.

42 | ChromLab Software, Security Edition


Activating ChromLab Software Security Edition on Remote Computers

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.

8. (Optional) Click Test Connection.

9. Click Activate Security Edition to connect to the shared database.

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.

10. Click Yes to continue the connection process.

ChromLab Administration closes. The next time it is started, ChromLab connects to the
shared database on the central computer.

Importing Existing ChromLab Data


To ensure that you can access your current data after you set up the shared database and
connect to it from the remote computers, import the data from all remote computers into the
shared database.

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.

To import ChromLab methods

1. Start ChromLab and log in as a ChromLab user.

2. Select File > Import and choose NGC File.

The Import NGC File dialog box appears.

3. Click Select.

The Select Project dialog box appears.

44 | ChromLab Software, Security Edition


Importing Existing ChromLab Data

4. In the Select Project dialog box, do one of the following:

n Choose a destination project for the method and click Select Project.

n Create a new project and click Select Project.

n Right-click on an existing project and select New Project to create a subproject


and then click Select Project.

5. In the Import NGC File dialog box, click Browse to display the Open dialog box.

6. Select the method to import and click Open.

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.

9. Click OK to close the dialog box.

The files are imported into the project you selected.

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

Rules for Sharing ChromLab Data


Once the remote computers are connected to the shared database, users can create and
modify methods, run methods, and analyze runs. To ensure data integrity, ChromLab
enforces the rules noted in Table 2.

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.

Table 2. Rules for sharing ChromLab data

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.

46 | ChromLab Software, Security Edition


Rules for Sharing ChromLab Data

Table 2. Rules for sharing ChromLab data, continued

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

Table 2. Rules for sharing ChromLab data, continued

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.

48 | ChromLab Software, Security Edition


Rules for Sharing ChromLab Data

Table 2. Rules for sharing ChromLab data, continued

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

Table 2. Rules for sharing ChromLab data, continued

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

50 | ChromLab Software, Security Edition


Chapter 6 The Security Edition Workspace
ChromLab Software, Security Edition provides an intuitive interface for developing
chromatography methods, operating an NGC instrument, and analyzing data from
chromatography runs.

ChromLab software presents four primary workspaces.

n The Home window

n The System Control window

n The Method Editor window

n The Evaluation window

Each workspace and the NGC instrument touch screen are shown and described in detail
in the NGC Chromatography Systems and ChromLab Software User Guide.

In Security Edition, you use ChromLab Administration to

n Activate ChromLab Security Edition

n Create and maintain user accounts

n Back up and restore the NGC database

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.

52 | ChromLab Software, Security Edition


ChromLab Administration

File Menu Command

Close — closes ChromLab Administration.

View Menu Commands

Show Inactive Users — displays currently active and deactivated Security Edition users.

Note: This option is enabled only on the User Administration tab.

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.

Help Menu Command

About — displays ChromLab Administration copyright and version information.

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Chapter 6 The Security Edition Workspace

The Security Edition Home Window


ChromLab Software, Security Edition opens with the Home window, which displays three
panes and the System Control tab.

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.

54 | ChromLab Software, Security Edition


Security Edition Menu Commands

Security Edition Menu Commands


Security Edition has the same menu options and menu commands as the standard edition
of ChromLab software. Additionally, Security Edition provides the Security menu option on
each window. This section describes the menu commands in the Security menu option for
all four windows.

Home Window
General Audit Log — displays the General Audit Log.

System Control Window


General Audit Log — displays the General Audit Log.

Method Editor Window


General Audit Log — displays the General Audit Log.

Sign Method — opens the Sign Method dialog box.

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.

Sign Run — opens the Sign Run dialog box.

Note: Only users assigned the Reviewer attribute can sign runs.

Show Analysis Audit Log — displays the audit log for the displayed analysis.

Sign Analysis — opens the Sign Analysis dialog box.

Note: Only users assigned the Reviewer attribute can sign analyses.

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Chapter 6 The Security Edition Workspace

56 | ChromLab Software, Security Edition


Chapter 7 Using ChromLab Software Security
Edition
Electronic Records
ChromLab Software, Security Edition enables you to create electronic records as defined
by 21 CFR Part 11. In Security Edition, the following data files are considered electronic
records:

n Methods

n Runs

n Analyses

n Audit log files

Security Edition data files are either uncontrolled, controlled, or signed. This section
defines these terms.

Uncontrolled Data Files


Uncontrolled data files have no audit log. They are not auditable according to 21 CFR Part
11 regulations. The following data files are considered uncontrolled:

n Imported methods

n New, unsigned methods

n Runs created from uncontrolled methods

n Analyses created from uncontrolled runs

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Chapter 7 Using ChromLab Software Security Edition

n Manual runs

n Column performance 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.

Controlled Data Files


Controlled data files have an audit log but are not signed. The following data files are
considered controlled:

n Unsigned runs based on signed methods

n Unsigned analyses based on controlled or signed runs

n Copies of signed runs or analyses saved as new data files

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.

Signed Data Files


Signed data files are controlled files that are signed by a user assigned the Reviewer
attribute. The following data files can be signed:

n Uncontrolled methods

n Controlled runs

n Controlled analyses

58 | ChromLab Software, Security Edition


Electronic Records

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.

Important: ChromLab will never overwrite or delete any signed file.

Identifying Data File Status


A controlled or signed file is identified by a specific icon beside its name in the browser and
in the open file. An uncontrolled file does not have an icon. See Identifying Data File Status
shows the icons that identify the status of data files.

Table 3. Identifying the status of data files


Icon Status Example

Uncontrolled file

Controlled file

Signed file

Signing Data Files


Note: Only users with the Reviewer attribute can sign or re-sign data files.

You can sign the following data files:

n Uncontrolled methods that have not been run

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.

n Controlled analyses from controlled or signed runs

To sign a file

1. Do one of the following:

n In the Method Editor, open the method to sign.

n In Evaluation mode, open the run or analysis to sign.

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).

60 | ChromLab Software, Security Edition


Electronic Records

5. If you manually edited the method during the run, you must provide a reason for each
change before you can sign the run.

a. Click View Audit Log to open the run’s audit log.

b. For each manual edit, click the ellipses button beside the highlighted Reason field
to open the Add Reason dialog box.

c. Provide a reason for each manual edit.

d. Click OK and then close the audit log.

6. Click Sign.

The file is saved in the project with the name shown in the signing dialog box.

To re-sign a data file

1. Do one of the following:

n In the Method Editor, open the method to sign.

n In Evaluation mode, open the run or analysis to sign.

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.

Importing Electronic Data Files


Only methods exported from the standard edition or the Security Edition of ChromLab
software can be imported into Security Edition. These files are uncontrolled. You cannot
import runs or analyses into Security Edition.

Exporting Electronic Data Files


You can export any saved data file from Security Edition. Exporting controlled or signed
files removes all audit log and signing information. The exported file is saved as an
uncontrolled data file.

62 | ChromLab Software, Security Edition


Electronic Records

Backing Up and Restoring the Security Edition Database


Important: In a shared ChromLab database environment, perform this task on the
central computer.

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.

To back up and restore the Security Edition database or set a reminder

u See Appendix B, Database Management, in the NGC Chromatography Systems and


ChromLab Software User Guide.

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.

Note: The following objects and events are not captured:

n Runs of uncontrolled methods

n Column performance tests

n Manual runs

n Scout runs

n Annotations

n Analyses of uncontrolled runs

n Run/Traces, Peaks, and Fractions table settings

n Chromatogram settings

n Changes to y-axis ranges

n Trace color and visibility

64 | ChromLab Software, Security Edition


Audit Logs

General Audit Log


The general audit log captures all events included in the run and analysis audit logs. In
addition, the general audit log captures the following events:

n System events including

o System calibration of the following modules:

n System pumps

n Sample pumps

n Column switching valve pressure values

n Conductivity monitor

n pH probe

o Changes to

n SIM input settings

n Air sensor settings

n Control flow rates

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.

n User administration events including

o Adding/modifying/deleting users

o Activating/deactivating users

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Chapter 7 Using ChromLab Software Security Edition

o User logins and exits

o Changes to user profiles

Run Audit Log


In Evaluation mode, all major actions and changes for a single run are audited. The entries
appear in the audit log after the run is saved. The run audit log includes the following run
events:

n Run start

n Injection point changes

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.

n Manual edits to method runs including

o Advance to next step

o Change flow rate

o Advance fraction collector

o Collect or waste fraction

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

66 | ChromLab Software, Security Edition


Audit Logs

Analysis Audit Log


In Evaluation mode, all major actions and changes for a single run analysis are audited.
The entries appear in the audit log after the analysis is saved. The analysis audit log
includes the following analysis events:

n Automatic peak integration events including

o Participating traces

o Integration parameters

o Peak filtering information

o Trace deletions

o Peak deletions

n Manual peak integration events including

o Peak range changes

o Peak deletions

o Peak splits

o Peak additions

n Undo/redo actions

n Peak table events including

o Changes to path length

o Changes to the extinction coefficient column

n Fraction table events including

o Changes to the extinction coefficient column

o Changes to pooling that affect child fraction rows

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Chapter 7 Using ChromLab Software Security Edition

n Injection point changes

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 Trace comparison events including

o Adding a controlled or signed run to a trace comparison

o Removing a controlled or signed run from a trace comparison

n Multiple-run analysis

Note: In Security Edition, trace comparisons and multiple-run analyses can


include both signed and controlled runs. Neither a trace comparison nor a
multiple-run analysis can be signed if any of the runs are uncontrolled. If the
analysis includes controlled but unsigned runs, you will be prompted to sign the
runs before you can sign the analysis.

Viewing Audit Logs


The following fields are displayed in each audit log:

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 Event — an explanation of the event.

n System name — the NGC system on which the method was run.

n Reason — the reason for the event.

Tip: Until the data file is signed, you can edit this text box. After the file is signed
this box is no longer editable.

68 | ChromLab Software, Security Edition


Audit Logs

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.

Viewing the General Audit Log

To view the general audit log

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.

To filter data in the general audit log

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.

The audit log displays the results of the filter.

To reset the filter settings in the audit log

u Click Reset All Filtering.

To hide filter options

u Click the Filter By arrow at the top of the window.

To sort data in the audit log

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).

(Optional) Click the heading again to perform a descending sort.

To display a full description of events

u Select the Show full event description checkbox at the bottom of the dialog box.

To print the audit log

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.

70 | ChromLab Software, Security Edition


Audit Logs

To close the audit log

u Click the red x at the top of the log.

Viewing the Run Audit Log

To view the run audit log

u In the open run, select Security > Run Audit Log. The run audit log appears.

Viewing the Analysis Audit Log

To view the analysis audit log

1. Do one of the following:

n Open the run and perform a peak analysis.

n Open the analysis.

2. Select Security > Analysis Audit Log. The analysis audit log appears.

User Guide | 71
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.

Signed Method Reports


Similar to a method report generated in the standard edition of ChromLab, the signed
method report includes all information about the method. It also includes a Signatures table
that contains the following fields:

n Time — the time of the event.

n Signed By — the name of the user who signed the method.

n Notes — additional information provided by the user.

72 | ChromLab Software, Security Edition


Signed Reports

Signed Run Reports


The signed single run report includes all information about a single run without peak
integration analyses. It also includes the option to print the run’s audit log and the run’s
method in the report. When the option Audit Log is selected, the signed run report includes
an Audit Log table that contains the following fields:

n Time — the time of the event.

n User — the name of the user who performed the activity.

n Event description — the details of each event.

n Reason — additional information provided by the user.

User Guide | 73
Chapter 7 Using ChromLab Software Security Edition

Signed Analysis Reports


The signed analysis report includes all information in the single run report as well as a list
of included runs and their methods, and information about trace comparison and peak-
detected runs. It also includes an Audit Log table that contains the following fields:

n Time — the time of the event.

n User — the name of the user who performed the activity.

n Event description — the details of each event including any changes to the method.

n Reason — additional information provided by the user.

74 | ChromLab Software, Security Edition


Appendix 8 Connecting Multiple ChromLab
Computers to One NGC System
With ChromLab software, multiple ChromLab computers can simultaneously connect to the
same NGC system.

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.

Rules for Managing Access to NGC Systems


Important: View mode applies only to users connecting to an NGC system through a
ChromLab computer. The NGC system’s touch screen is never in View mode. All
relevant features are available from the touch screen.

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.

User Guide | 75
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:

o The NGC system has a run in progress

o The system has queued runs pending

o The system has unsaved manual data

o A user is logged into the NGC system

Taking Control of an NGC System


Taking control of an NGC system 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.

Note: Only users assigned the Advanced User role can perform this task. Take Control
is disabled during system calibration or Point-to-Plumb actions.

To take control of an NGC system

1. If you have not already done so, connect to the target NGC system.

2. Select File > Take Control.

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.

76 | ChromLab Software, Security Edition


Chapter 9 Setting Up ChromLab Users and
Roles
To access ChromLab Software, Security Edition, each user must have a Security Edition
user account. The ChromLab administrator creates the user accounts and assigns each
account to predefined ChromLab roles. These roles are defined in the section Users and
Roles, which follows.

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.

n Each user can be assigned only one role.

Users and Roles


Security Edition has four security roles and a Reviewer attribute. Each ChromLab user is
assigned a role that provides the user access to specific software features. Table 4 lists the
Security Edition roles. Table 5 on page 79 provides a detailed list of permissions for each
role.

User Guide | 77
Chapter 9 Setting Up ChromLab Users and Roles

Table 4. ChromLab Security Edition roles

ChromLab Role Description

Administrator This role is designed for the ChromLab software


administrator.

Advanced User This role is designed for users requiring full access to
all Security Edition functionality.

User This role is designed for users requiring limited access


to Security Edition functionality.

Service User This role is reserved for service personnel to


troubleshoot and maintain NGC systems.

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.

78 | ChromLab Software, Security Edition


Users and Roles

Table 5. ChromLab permissions granted per role

Advanced Service
Administrator User User User

General

View audit logs X* X X X

Edit reason text box X* X X X


in audit log (add
comments)

* 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

View (open) signed X X


methods

Import uncontrolled X X
methods

Modify (save) X X
methods

Run uncontrolled X X X
methods

Run signed methods X X

User Guide | 79
Chapter 9 Setting Up ChromLab Users and Roles

Table 5. ChromLab permissions granted per role, continued

Advanced Service
Administrator User User User
Delete uncontrolled X X
methods

Delete signed
methods

Rename uncontrolled X X
methods

Rename signed
methods

Sign methods (with X X


Reviewer attribute)

Method Templates

Create new templates X X

View (open) X X X
templates

Modify (save) X X
templates

Delete user-defined X X
templates

Rename templates X X

80 | ChromLab Software, Security Edition


Users and Roles

Table 5. ChromLab permissions granted per role, continued

Advanced Service
Administrator User User User

System Control

Run manually X X X

Run at touch screen X X X

Run uncontrolled X X X
methods

Run signed methods X X

Change fluidic X X X
scheme

Calibrate NGC X X X
system

Delete fluidic scheme X X X

Create fluidic scheme X X X

Method run changes X X X

Map fluidic scheme X X X

Modify system X X
settings

Take control of NGC X


system

User Guide | 81
Chapter 9 Setting Up ChromLab Users and Roles

Table 5. ChromLab permissions granted per role, continued

Advanced Service
Administrator User User User

Runs

Create manual runs X X X

Open (view) manual X X X


runs

Open (view) X X X
uncontrolled runs
from an uncontrolled
method

Open (view) X X
controlled runs from a
signed method

Open (view) signed X X


runs

Modify manual runs X X X


(injection point,
column performance)

Modify controlled X X
runs from a signed
method (injection
point)

Modify signed runs

Rename manual runs X X X

82 | ChromLab Software, Security Edition


Users and Roles

Table 5. ChromLab permissions granted per role, continued

Advanced Service
Administrator User User User
Rename uncontrolled X X X
runs from an
uncontrolled method

Rename controlled X X
runs

Rename signed runs

Delete uncontrolled X X X
runs including:
n Column
performance runs
n Scout runs
n Manual runs
n Runs based on
uncontrolled
methods

Delete controlled runs X

Delete signed runs

Sign runs (with X X


Reviewer attribute)

Import runs

User Guide | 83
Chapter 9 Setting Up ChromLab Users and Roles

Table 5. ChromLab permissions granted per role, continued

Advanced Service
Administrator User User User

Analyses

Create analyses X X X

View uncontrolled X X X
analyses

View controlled X X
analyses

View signed analyses X X

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

84 | ChromLab Software, Security Edition


Users and Roles

Table 5. ChromLab permissions granted per role, continued

Advanced Service
Administrator User User User
Delete controlled X
analyses

Delete signed
analyses

Sign analyses (with X X


Reviewer attribute)

Copy controlled X X
analyses

Copy signed X X
analyses

ChromLab
Administration

Log into ChromLab X X X X


Administration

Back up and restore X


the Security Edition
NGC database

Set password rules X

View password rules X X X X

User Administration Tasks including:

n Add users X

User Guide | 85
Chapter 9 Setting Up ChromLab Users and Roles

Table 5. ChromLab permissions granted per role, continued

Advanced Service
Administrator User User User
n Delete users X

n Enable/disable X
users

n View own user X X X X


profile

n Change own user X X X X


password

n Edit own user X X X X


profile

n View all profiles X

n Change all X
passwords

n Edit all profiles X

86 | ChromLab Software, Security Edition


Managing ChromLab User Accounts

Managing ChromLab User Accounts


To access and use Security Edition, each user must be assigned a role. This section
explains how to manage user accounts.

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.

Adding User Accounts


Tip: If you have not yet done so, review the information in the section Users and Roles
on page 77

Important: Each user can be assigned only one role.

User Guide | 87
Chapter 9 Setting Up ChromLab Users and Roles

To add user accounts to ChromLab

1. On the Start menu, select ChromLab > ChromLab Administration and log in as a
ChromLab administrator. ChromLab Administration opens, displaying the User
Administration tab.

2. Click Add User. The Add User dialog box appears.

88 | ChromLab Software, Security Edition


Managing ChromLab User Accounts

3. Enter identifying information about the user in the text boxes.

Note: Information provided in the first name, last name, and username boxes
cannot include the following characters:

"/\[]:;|=,+*?<>

n First name — required.

n Last name — required.

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 Username — required. The username must be unique.

n Password — required. The initial password can be generic. Encourage users to


change their passwords after they first log in. See Setting Password Options on
page 93 for more information.

n Email address

User Guide | 89
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.

4. Do one of the following:

n Click OK. The user account is added to the ChromLab database.

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.

6. Close ChromLab Administration.

Editing a User Account


To edit a user account

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.

3. Click Edit User.

90 | ChromLab Software, Security Edition


Managing ChromLab User Accounts

The Edit User dialog box appears.

4. Do one of the following:

n Make the required changes to the account and click OK.

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.

6. Close ChromLab Administration.

User Guide | 91
Chapter 9 Setting Up ChromLab Users and Roles

Deleting a User Account


Note: You can delete only user accounts for which no data files are stored in the
Security Edition database. That is, you cannot delete user accounts that created or
modified methods, runs, or analyses. However, you can deactivate these accounts.
See Editing a User Account on page 90 for more information.

To delete a user account

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.

3. Click Delete User. A message similar to the following appears.

4. Click Yes to continue or No to cancel the action.

5. Close ChromLab Administration.

92 | ChromLab Software, Security Edition


Setting Password Options in Security Edition

Setting Password Options in Security Edition


To comply with 21 CFR Part 11, Security Edition gives administrators the ability to set
password options.

Setting Password Options


In Security Edition, ChromLab administrators can set password options.

To set password options

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.

3. Select the checkbox to enable the password option.

n Require upper case — the password requires at least one upper case letter.

n Require special characters — the password requires at least one of the


following characters:

User Guide | 93
Chapter 9 Setting Up ChromLab Users and Roles

! [
@ ]
% \
& ?
* /
( :
) ;
{ _ (underscore)
} - (hyphen)
. (dot)

n Require numerals — the password requires at least one numeral


(0–9).

n Require at least # characters — the password requires at least the specified


number of characters.

The default is five characters. You can increase or decrease the value.

n Change password every # months — the password must be changed at least


once every specified number of months.

n Do not allow previously used # passwords — ChromLab stores the specified


number of passwords for the user account and prohibits their reuse.

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.

4. Select or clear the option checkboxes as appropriate.

The system enforces the selected password options.

5. Click OK to save the password settings and close the dialog box.

94 | ChromLab Software, Security Edition


Starting ChromLab Software Security Edition

Starting ChromLab Software Security Edition


To start ChromLab Software, Security Edition, each user must log in with a valid username
and password.

To start Security Edition

1. Click the ChromLab icon to start the application.

2. In the Login dialog box, enter your username and password.

3. Click Login.

User Guide | 95
Chapter 9 Setting Up ChromLab Users and Roles

96 | ChromLab Software, Security Edition


Appendix A Troubleshooting Shared
Database Connection Issues
This appendix lists potential causes and suggested solutions for resolving connection
issues when remote ChromLab computers or NGC instruments cannot access the shared
database.

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.

Possible Causes for Shared Database Connection


Issues
Table 6 lists possible causes and solutions for issues connecting to the shared ChromLab
database.

User Guide | 97
Appendix A Troubleshooting Shared Database Connection Issues

Table 6. Possible causes and solutions for shared database connection issues

Possible Cause Possible Solution


Database server settings have n Change the database location properties on the central
changed computer and then reconnect each remote computer.
See Changing the Location Parameters of Shared
Database on page 100.

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.

n Uninstall SQL Server on the central computer. Then


reinstall ChromLab on the central computer.
See Uninstalling Microsoft SQL Server on the Central
ChromLab Computer on page 102.

n Contact Bio-Rad Technical Support for assistance.

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.

98 | ChromLab Software, Security Edition


Possible Causes for Shared Database Connection Issues

Table 6. Possible causes and solutions for shared database connection issues,
continued

Possible Cause Possible Solution


n Your site’s firewall or antivirus tools require specific
ports for network communication. SQL Server requires
port 1433, which might not be allowed in your firewall
environment.
See Appendix D, Firewall Configuration in the NGC
Chromatography Systems and ChromLab Software
Installation Guide for specific information.
See Article 287932 on Microsoft’s Knowledge Base site
for more information:
http://support.microsoft.com/kb/287932

n You removed ChromLab software from the central


computer and must manually add specific firewall rules.
See Manually Adding Inbound Firewall Rules on page
105.

n The shared database resides on another subnet, which


is not accessible from a remote ChromLab computer or
an NGC system. Verify that the central computer can
ping the remote ChromLab computer or NGC system
using ping command line.
See Verifying that All NGC Systems Can Reach the
Central Computer on page 23.
n Verify that routing between subnets or virtual local area
network (VLAN) is configured properly.
Contact your system or network administrator for
assistance.

User Guide | 99
Appendix A Troubleshooting Shared Database Connection Issues

Solutions for Shared Database Connection Issues


This section details possible solutions if remote ChromLab computers or NGC systems
cannot connect to the shared ChromLab database.

Changing the Location Parameters of Shared Database


If you moved the central ChromLab database to another computer, or changed the name of
the computer on which it is located, you must change the connection location properties.
You perform this task on the central computer through ChromLab Administration. Then you
can reconnect the remote computers to the central computer.

To change the location parameters of the central computer

1. Determine the computer’s name:

a. On the central computer, right-click the computer’s desktop icon and select
Properties.

The System Information screen appears.

b. Locate and note the computer name and full computer name.

c. Close the System Information screen.

2. Determine the computer’s IP address:

a. Open a command prompt window.

b. At the command prompt, type ipconfig.

c. Note the information on the line IPv4 Address.

Note: Ensure that the computer’s IP address is static.

d. Close the command prompt window.

100 | ChromLab Software, Security Edition


Solutions for Shared Database Connection Issues

3. Launch ChromLab Administration.

Note: If ChromLab Administration fails to connect, the Change Database Server


dialog box appears. Use this dialog box to

n Change the server address

n Specify the new settings

n Provide the administrator’s login credentials

n Connect to the central computer with the new settings you noted in Steps 1–2.

4. Exit ChromLab Administration.

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.

Restarting the NGC Database Service


Important: Ensure that ChromLab is not running before you restart the NGC database
service.

To restart the NGC database service

1. On the central computer’s desktop, right-click the computer’s desktop icon and select
Manage.

The Computer Management dialog box appears.

2. In the Computer Management dialog box, expand Services and Applications in the left
pane and select Services.

A list of services appears in the right pane.

User Guide | 101


Appendix A Troubleshooting Shared Database Connection Issues

3. In the list of services, locate and right-click SQL Server (NGC).

4. Select Start in the list of actions that appears.

5. Close the Computer Management dialog box.

Uninstalling Microsoft SQL Server on the Central


ChromLab Computer
Important: You might need to uninstall SQL Server if it is corrupted. Bio-Rad strongly
recommends that you back up all SQL Server databases you might have, close all
applications that use SQL Server, and uninstall the applications before continuing.

To uninstall Microsoft SQL Server

1. On the central computer, uninstall ChromLab first and then uninstall Microsoft
SQL Server:

a. Select Start > Control Panel > Programs and Features.

The Uninstall or change a program window appears.

b. In the list of installed programs, locate and select ChromLab.

102 | ChromLab Software, Security Edition


Solutions for Shared Database Connection Issues

c. Click Uninstall/Change to uninstall ChromLab.

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.

This folder is located at C:\ProgramData\Bio-Rad\NGC\Database. Rename the folder


to Database_old.

3. Reinstall ChromLab software on the central computer.

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.

6. Do one of the following:

n If you changed the name of the ChromLab central computer or its IP address, go
to Step 7.

n If you retained the computer’s name and IP address, go to Step 9.

7. On all remote computers, start ChromLab Administration and select the Database
Location tab.

8. Provide the required information and click Connect.

9. Start ChromLab on the remote computers and verify connection to the shared
database.

User Guide | 103


Appendix A Troubleshooting Shared Database Connection Issues

Changing the Connection Parameters to the Central


Computer
If you selected the central computer’s name as the connection parameter when you
connected to the shared database, you might need to change the connection parameter to
its IP address.

Tip: Skip Step 1 if you know the IP address of the central computer.

To change the connection parameters to the central computer

1. Determine the computer’s IP address:

a. Open a command prompt window.

b. At the command prompt, type ipconfig.

c. Note the information on the line IPv4 Address.

Note: Ensure that the computer’s IP address is static.

For more information about locating the IP address of a computer, see your
system or network administrator.

d. Close the command prompt window.

2. On each remote computer, open a command prompt window and ping the central
computer. For example:

> ping <Central_ChromLab_computer_IP_Address>

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.

104 | ChromLab Software, Security Edition


Solutions for Shared Database Connection Issues

4. In the Remote Shared Database dropdown list, select the IP address of the central
computer.

5. Click Connect.

6. Start ChromLab and verify the connection to the shared database.

Manually Adding Inbound Firewall Rules


Important: If you uninstall ChromLab from the central computer, you must create
custom inbound firewall rules in order for the SQL Browser and SQL Server services to
receive data from the network. Contact your system or network administrator or
Bio-Rad Technical Support for assistance.

n Bio-Rad NGC SQLServer NG

Enables communication to the NGC database

n Bio-Rad NGC SQLServer Browser

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.

Table 7. Firewall inbound rules for the ChromLab database

Remote
Rule Program Protocol Local Port Port
Bio-Rad NGC SQLServer Any Any Any Any
NG

Bio-Rad NGC SQLServer Any Any Any Any


Browser

Tip: See Appendix D, Firewall Configuration in the NGC Chromatography Systems


and ChromLab Software Installation Guide for more information.

User Guide | 105


Appendix A Troubleshooting Shared Database Connection Issues

106 | ChromLab Software, Security Edition


Appendix B Configuration Checklists
This appendix comprises checklists that you can use to prepare your site for and set up the
shared ChromLab database.

Preparing Your Site


Use this checklist to prepare the computers to use the shared ChromLab database.

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.

Table 8. Site preparation checklist

Task For Details


1. Determine the computer to host the
shared 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.

User Guide | 107


Appendix B Configuration Checklists

Table 8. Site preparation checklist, continued

Task For Details


4. Install ChromLab software on all See the NGC Chromatography Systems and
computers. ChromLab Software Installation Guide.
Note: You can upgrade ChromLab
software standard or Security Edition
from version 3.x or higher to version 6.1.
If you are running an earlier version of
ChromLab software, you must first
upgrade to 3.x before you can upgrade to
ChromLab 6.1.

5. Prepare the ChromLab central See Preparing the Central Computer and
computer and NGC systems. NGC Systems on page 15.

6. Prepare the remote computers. See Connecting Remote Computers to the


Central Computer on page 35.

108 | ChromLab Software, Security Edition


Setting Up the Shared Environment

Setting Up the Shared Environment


Use this checklist to set up the shared ChromLab database and connect to it from the
remote computers.

Table 9. Setting up the shared environment

Task Computer For Details


1. Verify that ChromLab 6.1 is All computers See the NGC
installed. Chromatography
Systems and ChromLab
Software Installation
Guide for details.

2. Create an NGC database backup All computers See Creating an NGC


folder. Database Backup Folder
on page 37.

3. Change the default admin All computers See Changing the


password in ChromLab ChromLab Default
Administration. Password on page 39.

4. Activate Security Edition and Central computer See Activating Security


designate the shared database. Edition on the Central
Computer on page 25.

5. Create ChromLab users and Central computer See Next Steps on page
assign roles 33.

6. (Optional) Export existing Remote computers See Exporting Existing


methods from all computers. ChromLab Data on page
38.

User Guide | 109


Appendix B Configuration Checklists

Table 9. Setting up the shared environment, continued

Task Computer For Details


7. Activate Security Edition and Remote computers See Connecting Remote
connect to the shared database. Computers to the Central
Computer on page 35.

8. (Optional) Import existing Central computer See Importing Existing


methodsto the shared database. ChromLab Data on page
44.

110 | ChromLab Software, Security Edition


Bio-Rad
Laboratories, Inc.

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Korea 82 2 3473 4460 Luxembourg 00 800 00 24 67 23 Mexico 52 555 488 7670 The Netherlands 00 800 00 24 67 23
New Zealand 64 9 415 2280 Norway 00 800 00 24 67 23 Poland 00 800 00 24 67 23 Portugal 00 800 00 24 67 23
Russian Federation 00 800 00 24 67 23 Singapore 65 6415 3188 South Africa 00 800 00 24 67 23 Spain 00 800 00 24 67 23
Sweden 00 800 00 24 67 23 Switzerland 00 800 00 24 67 23 Taiwan 886 2 2578 7189 Thailand 66 2 651 8311
United Arab Emirates 36 1 459 6150 United Kingdom 00 800 00 24 67 23

10000049093 Ver D (10044239) US/EG 04-20 Sig 0220

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