SYNGISTIX FOR AA AND ICP

User Setup
Software Guide
 Syngistix
User Setup Software Guide
Release History

Part Number Release Publication Date Software Version

09931535 B April 24, 2020 5.0

Any comments about the documentation for this product should be addressed to:

User Assistance
PerkinElmer, Inc.
710 Bridgeport Avenue
Shelton, Connecticut 06484-4794
U.S.A.

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Table of Contents
Welcome ............................................................................................................................... 9
Security .......................................................................................................................... 9
Integrity .......................................................................................................................... 9
Traceability ..................................................................................................................... 9
Using the User Setup Program ...............................................................................................11
To open the User Setup utility .........................................................................................11
Setting Up Users in the Software ............................................................................................13
Users & Groups ............................................................................................................ 15
About Users and Groups Settings ...........................................................................................17
Managing Users ....................................................................................................................18
How do I add a new user? ..............................................................................................18
How do I edit a user? .....................................................................................................18
How do I delete a user? ..................................................................................................19
How do I assign a user to a group? .................................................................................19
How do I remove a user from a group? ............................................................................19
How do I reinstate Locked Out users? ..............................................................................20
How do I disable an existing individual user? ....................................................................20
How do I set-up Windows/Domain Users instead of PerkinElmer Password Control .............20
Managing Groups ..................................................................................................................22
How do I create a new group? ........................................................................................22
How do I define what members of a group are able to do? ...............................................22
How do I edit a group? ...................................................................................................23
How do I delete a group? ................................................................................................24
How do I assign a user to a group? .................................................................................24
How do I remove a user from a group? ............................................................................24
Managing Password Settings ..................................................................................................25
To manage password settings .........................................................................................25
How do I change a Password ? ........................................................................................26
How do I define when users must change their password ? ...............................................27
How do I define the minimum length of time that users must retain the same password
before they are able to change it ? ..................................................................................27
How do I define the length of a password ? .....................................................................27
Can a password be reused ? ............................................................................................28
Do users have to enter a password ? ...............................................................................28
Is there a record of previous passwords ? ........................................................................28
How do I setup the No Passwords Login mode (Non-ES only) ? .........................................28
How do I setup Windows Login to Log in to the PerkinElmer software ? .............................30
How do I Log in to PerkinElmer software using my Windows Login ? .................................31
How do I remove a user from the PKIUsers Windows Group ? ...........................................31
Why can't I login to the PerkinElmer software using my Windows Login ? ..........................32
What should I do if I am logging into PerkinElmer software using my Windows Login and
I get a message that my password is due to expire ? ........................................................32
Login History.........................................................................................................................33
Audit Trail .............................................................................................................................34
Summary ..............................................................................................................................35
Data Folders ................................................................................................................. 37
Managing Data Folders ..........................................................................................................39
To select Users ...............................................................................................................39
To add a data folder .......................................................................................................39
To delete a data folder ....................................................................................................40
What Are the Default Storage Locations for Syngistix Data? ..............................................41
Electronic Signatures (ES only) ................................................................................... 43
Managing Electronic Signatures (ES only) ...............................................................................44
How do I add a reason for a signature point ? ..................................................................46

5
 How do I edit a reason for a signature point ? ................................................................. 46
How do I delete a reason for a signature point ? .............................................................. 46
How do I reorder the reasons listed for a Signature Point ? .............................................. 46
Email Setup .................................................................................................................. 47
Managing Email .................................................................................................................... 49
To Setup Email/Text ....................................................................................................... 49
To add an email address ................................................................................................ 49
To add a text address .................................................................................................... 50
Notifications ................................................................................................................. 51
Managing Notifications .......................................................................................................... 53
Settings ........................................................................................................................ 55
Managing Settings ................................................................................................................ 57
Using the User Setup P rogram

7
8 . Syngistix User Setup Software Guide
 Welcome . 9

W elcom e
The User Setup program is designed as an application tool that allows you to set Syngistix
permissions and data storage locations on a per user basis. This Help file provides you with
information on how to use the User Setup program.
The ES software provides the security and integrity your lab requires for electronic records.
System administrators can manage user access to various software functions through
configurable permissions. During routine operation, the Enhanced Security software
automatically records changes to key operational profiles such as method, mass calibration,
and conditions files and tracks system operations in the audit trail.
Some of the key features of the ES software include the following:

Security
Administrators of the Syngistix for ICP ES software and password protected database can
configure users and assign them to different groups with each group assigned a specific set
of permissions. Your ES administrator defines these groups and assigns permissions based on
the needs of your users and lab environment. Along with the use of passwords to gain access
to the software, these features permit overall access to be managed appropriately in a
regulated environment.
The system administrator can determine whether different users can normally access the
same files such as method, conditions, sample, and report files. Files are located on the
instrument computer.

I ntegrity
The ES software applies a checksum to all data files completely transparent to the user. If
someone alters the data outside of the Syngistix software, for example by altering the
analysis time or changing the concentration value, this alteration is detected by the ES
software when the file is next accessed.
The software automatically tracks version numbers for all files and moves old versions to a
database. Differences between versions can easily be reported using the File Changes mode
in ES Tools.
Every time an analysis is performed, the ES software saves a copy of all pertinent analysis
parameters with the analytical results. The data saved includes method and instrument
parameters, analytical calibrations, logged-in originator, and signing users.
Reprocessing does not change the stored data, but rather new data are written to the
dataset along with a notation that the data represent reprocessed data rather than original
data. This provides a permanent record of all results regardless of whether they are from the
initial analysis or post-analysis reprocessing.
Data archival tools are also provided in the ES software to facilitate complete and accurate
archival of data on other storage media. Once archived, the analytical data along with the
respective audit trail entries can be restored at a future date for review or audit purposes.

Traceability
Significant actions performed by the user are recorded in an audit trail and event log with the
date and time of the action, what was done, the name of the user, and the reason the action
was performed. The audit trail can be filtered by several data fields and then viewed on-
screen, printed, or archived (if set up by the administrator).
The ES software does not permit analyses to be performed without saving the resultant data.
The security features also ensure that analyses are conducted only with methods and other
10 . Syngistix User Setup Software Guide

parameter files that have been saved. These restrictions ensure that a proper audit trail is
maintained for all activities.
 Using the User Setup Program . 11

Using the User Setup Program

This guide provides information that helps you become familiar with the different areas of the
User Setup program. The User Setup program consists of six buttons that you use to define
Syngistix users, permissions, and data storage locations, as well as view a report of the User
Setup settings that are currently applied.
The User Setup window allows the ES software administrator to add users and modify their
settings, manage working folders, and select which ES features are available.

To open the User Setup utility

1. Click the Start button then navigate to PerkinElmer Syngistix for ICP, click the
down arrow to expand the listing and select User Setup.
The Syngistix Login dialog box appears.

2. Type in your User Name and Password (the user must have administrator privileges),
and then click OK.
The User Setup window appears.

Following is an overview of each button:

o Users & Groups
You use this page to identify those individuals who are able to access Syngistix. Click
here for more information.
o Data Folders
You use this page to assign group or individual data folders and paths. Deletion
protection is set by the user's Windows system. Click here for more information.
o Electronic Signatures (ES only)
You use this page to set up Electronic Signatures. Click here for more information.
12 . Syngistix User Setup Software Guide

o Email Setup
You use this page to set up email and text messages. Click here for more
information.
o Notifications
You use this page to set up notifications of Events (for example, Login Failure,
Password rest, etc) to your email address or a text message. Click here for more
information.
o Settings
You use this page to set an Application lockout time and/or Enable INconX. Click
here for more information.
On the bottom of each tab page the following buttons are available:

o - Click this question mark button for information on using this tab.
o Apply - Click this button to save all of the changes you have made.
o OK - Click this button to save all of the changes you have made and close the User
Setup application.
o Cancel - Click this button to close the User Setup application without saving
changes.
o Print - Click the Print button to print the User Setup report.
o Archive - This button is only available on the Login History, Audit Trail, and
Summary tabs.
o Export - This button is only available on the Summary tab.
 Setting Up Users in the Software . 13

Setting Up Users in the Softw are

To set up a new user in the software:
1. Log into Windows as an Administrator. Enter your Administrator password.

2. Click the Start button then navigate to PerkinElmer Syngistix for ICP, click the
down arrow to expand the listing and select User Setup.
The Syngistix Login dialog box appears.

3. At the prompt, type the User Name and Password for your Administrator account.
If this is the first time that you are logging in to the software, you are prompted to
change the password (initially set at installation). Type the new password and repeat
the same password in the Confirm Password box. Write down your new password.
4. Click OK. The User Setup dialog box appears.
5. Click Users & Groups.
The Users, Groups, Password Control, Login History, Audit Trail and Summary dialog
box appears.
6. On the Users tab, click New.
The New User dialog box appears:
• In the User Name field, type the user’s User Name or unique ID.
• In the Full Name field, type the user's full name.
• In the Password field, type 123456 to serve as an initial default password.
• In the Confirm Password field, type 123456 again, and then click OK.
7. In the Status section select Enabled or Disabled.
8. Click OK to save your entries and close the dialog.
9. In the Available groups for user list, select a group (such as Chemists), and click
Add to move the group name to the User is a member of list.
10. Click Apply to apply the setting and then click OK to close the dialog.
11. Click Data Folders.
The Data Folder window appears.
12. Click Select User and select the user’s name from the drop-down list. Click Apply, and
then click OK.
13. Close the User Setup window.
14 . Syngistix User Setup Software Guide

14. Write down the user’s name and the temporary password (123456) and give it to the
user. The user must change their password when they first log into the software.
Users & Groups

15
16 . Syngistix User Setup Software Guide
 About Users and Groups Settings . 17

About Users and Groups Settings

The Users & Groups button provides tabbed dialog for you to set up and display the
following:
 Users
 Groups
 Password Control
 Login History
 Audit Trail
 Summary
 18 . Syngistix User Setup Software Guide

M anaging Users
When the software is installed, a user with administrator privileges and a group called
Administrators is already created for you. You can log in as the administrator (using the user
ID specified during installation) to create other users. You can add other users to the
Administrators group so that they can also manage your security settings.

Note: The Adm inistrators group is set up to allow for administrative tasks only, and does not
confer any specific permissions for working with the ES software.
You modify user settings from the Users tab. To access it from the User Setup window,
click Users & Groups. In the Users, Groups, Password Control and Summary dialog box,
click the Users tab. To apply the changes you make and continue working in this dialog box,
click Apply. To apply changes and close the dialog box, click OK.

Note: A user must be a member of at least one Group in order to login and use the Syngistix
application. If a user is not a member of any Group, a login attempt will fail as if the user
name or password is invalid.

How do I add a new user?

When a new person needs to use the Syngistix software, you must create a user name for
them. After you create a user name, you must assign the user to a group.
1. Click Users & Groups from the Setup menu or click the Users & Groups icon in the
User Setup window.
The Users, Groups, Password Control, Login History, Audit Trail, and Summary dialog is
displayed.
2. Select the Users tab and click New.
The New User dialog is displayed.
3. Enter the User name, Full name, and Password for the user. Re-enter the Password
in the Confirm Password field.
You can specify the minimum length of passwords when you manage password settings
in the Password Control tab.

Note: The Password is case-sensitive. It can consist of letters, numbers and single spaces only.
The maximum password length is 16 characters.
4. Specify whether the user is Enabled or Disabled.
You disable a user if you do not want them to use the software (for example, if they
leave your laboratory).

Note: The Enhanced Security software requires all new users to change their passwords when they
first log in. As a result, the User must change password at next login check box is selected
and unavailable.
5. When you are finished, click OK.
The new user is created and appears in the Name drop-down list.

How do I edit a user?

If you need to change settings for an existing user, such as a password, you can edit a user's
profile.
1. On the Users tab, select a user from the Name drop-down list, and then click Edit.
The Edit User dialog box appears.
 Managing Users . 19

2. If desired, change the Full name or Password (and re-enter the password in the
Confirm Password field), and specify whether or not the User must change password at
next login.

Note: ou cannot change the User name. You can specify the minimum length of passwords when
you manage password settings in the Password Control tab.
3. You can choose to enable or disable the user by clicking Enabled or Disabled.
You might disable a user if they will no longer be using the Syngistix software. For
instance, you might want to keep track of user IDs for former employees. If you enable
a previously disabled user, you must change that person's password.

Note: You cannot disable all users in the Administrator group; there must always be at least one
enabled Administrator.
4. When you are finished, click OK.

How do I delete a user?

When a particular user ID is no longer required, you can delete it. Note that a deleted user
ID cannot be used again for a new user.
1. On the Users tab, select a user from the Name drop-down list, and then click Delete.
2. When prompted to confirm the deletion, click Yes.
The user is removed from the Name drop-down list.

Note: It is not possible to reuse a User name that has been deleted.

Note: It is not possible to delete the Administrator from the Administrators group.

How do I assign a user to a group?

After you have created a user, you must assign that user to one or more groups so that their
permissions are defined. For more information about groups, see
1. On the Users tab, select a user from the Name drop-down list.
2. In the Available groups for user list, click the group or groups to which you want to
assign the user, and then click Add.
The groups appear in the User is a member of list.

Note: When a group is added to the User is a member of list, it no longer appears in the Available
groups for user list.

How do I rem ove a user from a group?

3. On the Users tab, select a user from the Name drop-down list.
4. In the Group Membership section, select the group from the User is a member of
list, and click the Remove button.
The user is removed from the group. The group is removed from the User is a
member of list, and is added to the Available groups for user list.

Note: You cannot delete all users from the Administrator group; there must always be at least one
active Administrator.
 20 . Syngistix User Setup Software Guide

How do I reinstate Locked Out users?

If the Lockout is set to Permanent and the user has failed to login correctly within the
allowed number of attempts, the administrator must assign a new password before they are
able to login again.
When the administrator next logs in after a user has been locked out, a list of Locked Out
Users is displayed.
1. Highlight the name of the user that you wish to reinstate and then click Edit.
The Edit User dialog is displayed.
2. Enter a new Password and repeat it in the Confirm password field.
3. Click OK.
The user is removed from the list of Locked Out Users.
4. Click OK to close the Locked Out Users dialog.
The previously locked out user will now be able to login using the new password, which
they will be forced to change if you are using the Enhanced Security version of
software. If you are using the Standard version, the user will only be forced to change
the password if User must change password at next login was selected.

Note: If you click OK rather than Edit when the list of Locked Out Users is displayed, the list is
closed and the Explorer starts. Any locked out users will remain locked out. The list will be
redisplayed each time you login until any locked out users have each been assigned a new
password.

Note: Users locked out for a specified duration can be unlocked by the administrator in the same
manner.

How do I disable an ex isting individual user?

1. Select the user's Name from the drop-down list and click Edit.
An Edit User dialog is displayed.
2. To disable the user, in the Status section select Disabled.
When the disabled user attempts to login an error message will be displayed informing
them that their login failed.
3. Click OK.
The User is disabled. The Group membership section of the Setup Users and Groups
dialog is grayed when a disabled name is selected in the Name list.

Note: To enable the user, select Enabled on this dialog. You must also enter and confirm a new
password when enabling a user.

Note: All user updates are recorded in the audit log in the Enhanced Security version of software.

How do I set-up W indow s/ Dom ain Users instead of

P erk inElm er P assw ord Control
To use Windows Passwords instead of PerkinElmer Passwords:
1. Set up the computer users and add them to the PerkinElmer Users Group and the
Administrators group.
2. Load Syngistix, if Syngistix is already installed and you are switching to Windows users
only the first user added to the group will be active and have administrator rights.
 Managing Users . 21

3. Right-click to assign a password to them (or have them assign themselves one in
Account Settings) or Syngistix will not allow you to open it. Syngistix does not work with
PINs or Picture Passwords. Those are only for logging into the computer.
4. Open up User Setup with those credentials (doesn't matter which computer user you
are logged in as) and give everyone else permission. If no Administrator is assigned
already, Syngistix will ask you to assign a user name from the drop-down list.
The Users tab page is used to identify those individuals who will be able to use Syngistix. On
the Password Control tab page there are two types of Windows user Login Types
(PerkinElmer Login and Windows Login) and they are differentiated based upon how they are
authenticated by the operating system. A user can be authenticated by being a user on the
local computer, or he can be authenticated by being a domain user.
 22 . Syngistix User Setup Software Guide

M anaging Groups
In the +software, Groups are categories to which users belong that give them certain
permissions. You can create, modify, and delete groups according to your policies. After
creating a user, you assign the user to one or more groups. When the software is installed,
an Administrators group is automatically created — it cannot be modified or deleted, it does
not appear on the Groups tab.

How do I create a new group?

When you need to assign a particular set of permissions to a set of users, you can add a
group.

Note: It is not possible to create a new group within the Standard version of software.
1. In the User Setup window, click Users & Groups.
The Users, Groups, Password Control, Login History, Audit Trail,and Summary dialog is
displayed.
2. Click the Groups tab and click New.
A New Group dialog is displayed.
3. Enter a Group name for the group and click OK.
The new group appears and is selected in the Name drop-down list.

How do I define w hat m em bers of a group are able to do?

The permissions available to each group are selected on the Groups tab. The permissions are
listed as a tree structure. When a new group is created, none of the permissions are selected
by default.
1. To select all the permissions click Permissions at the top of the tree - Example
All the permissions are automatically checked.

OR
To assign one or more (but not all) permissions, click in the box next to the
permission you wish to assign to the group.
A check mark indicates that the permission is available for the group.
For ES only: Disallowing self-review and self-approve/rejection of files and
data.
By default all check boxes are clear (unchecked) so that nothing is allowed. More
specifically, only an administrator can set to allow the following permissions for a
Group:
 Managing Groups . 23

• Allow self-review of files and data.

• Allow self-approve/reject of files and data.

Note: When only some of the permissions are selected, the check box at the top of the tree is
grayed to indicate that not all of the options are selected - Example

2. When all the required permissions are selected, click Apply.

The available options for the group are updated.

Note: The numbers at the end of each permission relate to the database. When you view the audit
trail, it is these numbers that are listed rather than the description of the permission. You will
need to refer back to the list of permissions on the Groups tab to find the number that
relates to a particular permission, or look at the summary where the permission together
with the number is given.

How do I edit a group?

You change the properties of a group in the Permissions section of the Groups tab. Members
of that group will be able to perform the actions that you specify.
1. On the Groups tab, select a group from the Name drop-down list.
The Members of this group are able to box displays the permissions associated with that
group in a tree structure.
2. In the Members of this group are able to box, set permissions for the group as
follows:
• Select the check boxes of the permissions you want to assign to members of this group.
• To remove a permission from a group's capabilities, clear the corresponding check box.
 24 . Syngistix User Setup Software Guide

• To select all of the permissions within a branch, click the check box beside the
parent of that branch.
• To expand a branch, click the plus sign icon. To collapse it, click the minus sign
icon.
• If you select a check box within a branch, the check box beside the parent
permission in the tree contains a gray check mark.

Note: The number that appears in square brackets after each permission is how that permission is
referenced in the audit trail. If the permission is referenced in the audit trail, it is this number
that appears, not a text description of the permission. To determine which permission is
being referenced in the Audit Trail, you must look at this list.
3. When you are finished, click OK.

How do I delete a group?

When a particular group is no longer needed, you can delete it.

Note: If you delete a user's only group, that user cannot use the ES software until you assign that
user another group. Ensure that any affected users belong to a group.
4. On the Group tab, select a group from the Name drop-down list and then click Delete.
You are prompted to confirm the deletion. If the group you are trying to delete has
users assigned to it, the confirmation dialog box informs you of this.
5. To confirm deletion click Yes.
The group disappears from the list.

How do I assign a user to a group?

After you have created a user, you must assign that user to groups so that their permissions
are defined. For more information about users, see Managing Users.
1. On the Users tab, select a user from the Name drop-down list.
2. In the Available groups for user list, click the groups to which you want to assign the
user, and then click Add.
The groups appear in the User is a member of list..
If you wish to create more than one new user and assign each of them to a
group/groups you must click Apply after assigning the groups to the first user before
creating the next new user otherwise the group assignments for the currently selected
user will be lost.

Note: When a group is added to the User is a member of list, it no longer appears in the Available
groups for user list.

How do I rem ove a user from a group?

1. On the Users tab, select a user from the Name drop-down list.
2. In the Group Membership section, select the group from the User is a member of
list, and click the Remove button.
The user is removed from the group. The group is removed from the User is a
member of list, and is added to the Available groups for user list.
NOTE: The Administration Audit Trail records all changes to security settings in compliance with 21
CFR Part 11. All changes to users, groups, password settings and signature points are
recorded.
 Managing Password Settings . 25

M anaging Passw ord Settings

In the software, if your corporate security policies require it, you can specify how users
manage their passwords.

To m anage passw ord settings

1. In the User Setup window, click Users & Groups.
The Users, Groups, Password Control, Login History, Audit Trail, and Summary dialog
box appears.
2. Select the Password Control tab.

3. You can specify the following settings:

• Login Type: Select your login type PerkinElmer Login, Windows Login, or No
Passwords Login (Non-ES only) from the drop-down list.
• Maximum password age: Specify whether or not users' passwords expire, and if
they do, after how many days.
• Minimum password age: Specify whether or not to allow users to change their
passwords immediately, and if not, after how many days.
• Minimum password length: Specify the minimum number of characters in the
password.

Note: The Password is case-sensitive. It can consist of letters, numbers and single spaces only.
The m ax im um passw ord length is 16 characters.
• Password uniqueness: Specify the number of past passwords to remember so
that the user cannot repeat recently used passwords.
• Account Lockout: Click this button. In the Account Lockout dialog box, specify
the number of failed logon attempts allowed before a user is locked out of the
system. Also, specify whether the lockout is permanent or limited to the specified
number of minutes.
• Lockout: The number of failed login attempts allowed before a user account is
locked out.
The administrator receives an email/text notification when a user reaches the
maximum number of failed login attempts.
 26 . Syngistix User Setup Software Guide

• Lockout Duration: The time for which a user remains locked out.

Note: Never select a P erm anent Lockout duration for an administrator, as there is a risk that the
administrator will be locked out of the software indefinitely. If the administrator forgets the
password and is locked out, contact PerkinElmer service.
4. To apply the changes you make and continue working in this dialog box, click Apply.
To apply changes and close the dialog box, click OK.

Note: The settings on this tab apply to all users. You cannot define different password control
settings for different users or groups.

How do I change a P assw ord ?

1. To change a user's password, select the user from the Name drop-down list on the
Users tab and then click Edit.
An Edit User dialog is displayed.

2. Enter the new Password and repeat it in the Confirm password entry field.
3. Click OK.
The new password is implemented. The next time the user logs in they will be forced to
change their password if you are using the Enhanced Security version of software. In
the Standard version of software, the user will only be forced to change their password
if User must change password at next login has been selected.

Note: If you have the Standard version of software, you will be unable to change the default
passwords accessed via the Login dialog for the first day after installation. If you attempt to
change a password, the following message is displayed: 'You have changed your password
less than 1 days ago. You cannot change your password again'. This is due to the default
 Managing Password Settings . 27

setting for M inim um passw ord age, where Allow changes after (days) is set to 1. If
you wish to change the password within the first day, the Administrator must select the
Allow Changes I m m ediately option on the Password Control tab of the Users, Groups,
Signatures and Password Control dialog.

How do I define w hen users m ust change their passw ord ?

Note: The settings on the Password Control tab apply to all users. It is not possible to define
individual Password controls for each user.
On the Password Control tab, Maximum password age defines the maximum number
of days that users can retain the same password before they must change it. By default the
password expires after 42 days. The minimum is 1 day and the maximum is 999 days.
The Maximum password age cannot be set less than or equal to the Minimum
password age.

Note: If you want to set the Maximum password age to 1 day the Minimum password age must
first be set to Allow changes immediately.
If it is not necessary for users to change their password, select Password never expires.
Within the ES version of the software users are forced to change their password the very first
time they login.

How do I define the m inim um length of tim e that users

m ust retain the sam e passw ord before they are able to
change it ?
On the Password Control tab, Minimum password age defines the number of days that users
must retain the same password before being allowed to change it. The default is to Allow
changes after 1 days. Allow changes after x days prevents users from changing their
password several times in a short space of time in order to return to a previous password.
To allow users to be able to change their password immediately, select Allow changes
immediately.
The Minimum password age cannot be set greater than or equal to the Maximum
password age. The minimum is 1 day and the maximum is 999 days.

Note: If you want to set the Maximum password age to 1 day the Minimum password age must
first be set to Allow changes immediately.
Within the ES version of the software, users will be forced to change their password the very
first time they login.
Within the Standard Security version of the software, select Change Password at First
Login to force users to change their password the very first time they login.

How do I define the length of a passw ord ?

Minimum password length on the Password Control tab defines the minimum number of
characters that must be used in the password. By default, At least 6 characters is
selected. The minimum is 1 and the maximum is 16 characters.
Allow blank password is an alternative option. This means that users are not required to
enter a password on login, providing the user has previously opted to not enter a password
when they last changed their password, or if they have never logged in before.
 28 . Syngistix User Setup Software Guide

Note: A second blank password cannot be used immediately when a blank password expires if
Num ber of passw ords to rem em ber has been selected in the Password uniqueness
section of the Password Control tab.

Note: Allow blank passw ord is not available within the Enhanced Security (ES) version of the
software.

Can a passw ord be reused ?

Users are able to reuse a previous password. By default, Number of passwords to remember
is set to 24.
Password uniqueness on the Password Control tab defines the number of new passwords
that must be used before a previous password can be reused. For example, if the first
password is 'security', and Number of passwords to remember is set to 3 entries, users
must use 3 other passwords in addition to their current password before they are able to
reuse 'security' as their password. The minimum is 1 and the maximum is 24.
If Do not keep password history is selected a user is able to reuse a password whenever
they wish.

Note: Do not keep passw ord history is not available in the Enhanced Security version of
software.

Do users have to enter a passw ord ?

If you are using the Enhanced Security (ES) software, a password is mandatory. However,
this is not the case within the Standard Security version of the software. Users can either be
asked for just their User name or their User name and password.
1. Click Users & Groups from the Setup menu or click the Users & Groups icon in the
User Setup window.
The Users, Groups, Password Control, Login History, Audit Trail, and Summary dialog is
displayed.
2. Select the Password Control tab.
3. In the Login Type section, select either PerkinElmer Login or Windows Login.
PerkinElmer Login requires the user to enter the User name and Password. Windows Login
requires that a PKIUsers group created during the installation of the software has been
populated with the required users by an IT Administrator. See How do I setup Windows
Login to Log in to the PerkinElmer software ? below.

I s there a record of previous passw ords ?

Within the ES version of the software a record of previous passwords is automatically made
and there is no way of turning this off.
Changes to passwords are recorded in the Audit Trail. However the actual passwords are not
visible; the word Hidden is displayed instead.
Within the Standard Security version, select Do not keep password history if you do not
wish to retain a record of the number of previous passwords.

How do I setup the No P assw ords Login m ode (Non-ES only) ?

This is also known as the Hide Login feature and it is only for the Non-ES version. If the
ES version has already been installed and a user wants to use this feature, what they need to
do is not only uninstall the ES version, but also remove GSC data before installing Non-ES
version.
 Managing Password Settings . 29

When in the No Passwords Login mode, the login window contains a Hide login upon
initialization check box that when checked, hides the login window upon initialization of the
application (i.e., Syngistix main app, Offline, and Data Manager).

• Once this feature is set, when logging in to Syngistix, a user checks the Hide login
upon initialization check box and logs in. Upon the next initialization, Syngistix will
login using the last logged in user.

• To change back to show the login upon initialization, in the ball menu of
Syngistix, there is a menu item: "Show Login". Once selected, the login window
with the check box for hide login will be shown. A user can then uncheck the box
and login. Upon next initialization of Syngistix will show the login screen.

Note: This setting does not apply to the Installer, Reconfigure, User Setup, and Switch User;
therefore, a user will not see the check box.
 30 . Syngistix User Setup Software Guide

How do I setup W indow s Login to Log in to the Perk inElm er

softw are ?
It is possible to login to PerkinElmer software using your Windows User Name and Password
instead of having a separate software User Name and Password.
During the installation of the PerkinElmer software, a PKIUsers group is created. All users
who wish to log in to the PerkinElmer software using the Windows User Name and Password
must first be added to the PKIUsers group by the IT Administrator.
1. Install the PerkinElmer software.
2. From the Start menu, navigate to Control Panel.
3. Double-click on User Accounts.
4. Select the Advanced tab.
5. Click Advanced.
The Local Users and Groups dialog is displayed.
6. Click on the Groups folder to see the list of available Groups on the PC.
PKIUsers Groups is selected.
7. Double-click on PKIUsers on the right-hand side of the dialog.
The PKIUsers Properties dialog is displayed.
8. To add a member (user) to the Group, click Add.
The Select Users or Groups dialog is displayed.
9. To change the Location, click Location and then select the required location for the
user you wish to add.
10. To add a user to the group, click the domain name of the user and then click Check
Names.
Clicking Check Names will validate the name on the specified domain.
11. Click OK.
The Select Users or Groups dialog is closed and the user is added to the PKIUsers
Properties dialog.
12. To add more users, repeat steps 7 to 11.

Note: It is possible to add a user more than once if they are on more than one domain as each
Location together with the user name and Password will be unique.
All users added to the PKIUsers Group will now be able to log in to PerkinElmer software
once the software Administrator has defined the Login Type as Windows Login (as described
below):

Note: The Login Type (Windows Login, PerkinElmer Login or No Passwords Login (Standard version
only)) applies to all users. It is not possible to have some users that log in using their
Windows Login while others use a separate software login.
13. From the Start menu select the required software application.
14. Log in as an Administrator.
15. From the Tools menu select Administration and then select Setup Users and Groups.
The Users, Groups, Password Control, Login History, Audit Trail, and Summary dialog is
displayed.
16. Select the Password Control tab.
17. From the Login Type drop-down list select Windows Login.
All the other information previously displayed on the tab is removed as the password
 Managing Password Settings . 31

controls are from Windows rather than the software application. The Windows users
will be loaded and you may be prompted to select a new Administrator.
Users must then be added to the required software application group:
18. Select the user from the Name drop-down list on the User tab.
19. Select the Group from the list of Available groups for user and then click Add.
The Group is added to the User is a member of list.
20. Click OK to close the The Users, Groups, Password Control, Login History, Audit Trail,
and Summary dialog is displayed and apply the changes.

Note: When using the Windows Login, at least one user must be assigned Administrator rights. If
not, it will not be possible to exit the software. If a user is not added to at least one group,
an error message will be displayed when they try to log in informing them that they do not
have access to the application.

Note: During the installation of the PerkinElmer software, PE21CFR server, 21CFR_Admin group
and 21cfr admin user are installed. PE21CFR server needs to run under Windows admin
authority. By default it uses the 21cfr admin user for this. You can change which user is
used to run PE21CFR using the PE21CFR configuration program (config21cfr.exe) which can
be found under C:\Program Files\PerkinElmer\PE21CFR. Running config21cfr.exe displays the
Enhanced Security Configuration dialog. Select the Security Server tab and change the
Account Name. Click Save and Close for the new Account Name to be activated. For further
information about the Enhanced Security Settings, see Enhanced Security Settings.

How do I Log in to P erk inElm er softw are using m y

W indow s Login ?
1. From the Start menu select PerkinElmer Applications, and then select the required
application.
2. Enter your User name and Password.
3. If the Log on to field is not displayed, click Options>> to show the field.
4. Select the required Domain from the Log on to drop-down list.
By default, the Domain last logged on to is displayed.

Note: If all users are on the same Domain, there is no need to show the Log on to field as the
correct Domain will be listed. It may avoid confusion to users if this field is hidden. If the Log
on to field is shown, click Options<< to hide it.

How do I rem ove a user from the P KI Users W indow s

Group ?
1. From the Start menu, select Control Panel.
2. Double-click on User Accounts.
3. Select the Advanced tab.
4. Click Advanced.
The Local Users and Groups dialog is displayed.
5. Click on the Groups folder to see the list of available Groups on the PC.
PKIUsers Groups is selected.
6. Double-click on PKIUsers on the right-hand side of the dialog.
The PKIUsers Properties dialog is displayed.
 32 . Syngistix User Setup Software Guide

7. To remove a member (user) from the Group, select the required member and then click
Remove.
The user is removed from the Group.
Why are the Users I have added to the PKIUsers Group for the Windows Login not displayed
on the Users tab of the Users, Groups, Password Control, Login History, Audit Trail and
Summary dialog?
Any users added to the PKIUsers Group before logging into the PerkinElmer software for the
first time will appear in the Name drop-down list on the Users tab of the Users, Groups and
Password Control dialog. If users are subsequently added, you must click Refresh Users on
the Users tab for the list to update.

W hy can't I login to the Perk inElm er softw are using m y

W indow s Login ?
There may be a number of reasons why you can't login using your Windows Login. Check
each of the following:
• Your IT Administrator has added your name to the PKIUsers Group (See "How do I
setup Windows Login to Log in to the PerkinElmer software?" above)
• You have been assigned to at least one Group within the PerkinElmer software (See
How do I setup Windows Login to Log in to the PerkinElmer software ? above) and
that Group has permission to access the application you are trying to start.
• You have entered the correct User Name and Password, and selected the correct
Domain from the Log on to drop-down list.
• PE21CFR is still running. From the Start menu select Control Panel, and then select
Administrative Tools. Then select Services. In the Services dialog check that
PE21CFR is still running. If this has been paused or stopped you will be unable to
login to the PerkinElmer software.

W hat should I do if I am logging into Perk inElm er

softw are using m y W indow s Login and I get a m essage
that m y passw ord is due to ex pire ?
If whilst logging into PerkinElmer software you get a message that your password is about to
expire, you can change your password. This change will be implemented by Windows as well
as the PerkinElmer software.

Note: The Administration Audit Trail records all changes to security settings in compliance with 21
CFR Part 11. All changes to users, groups, password settings and signature points are
recorded.
 Login History . 33

Login History
1. In the User Setup dialog box, double-click Users & Groups. The Users, Groups,
Password Control, Login History, Audit Trail, and Summary dialog box appears.
2. Select the Login History tab to display a history list of users attempting to login, along
with the following information:

Note: The Login History can only be viewed by users who are members of the administration
group.
• Full Name - the full name of the user.
• User Name or ID - the login user name of the user.
• Computer - the name/ID of the computer used.
• Status - OK indicates that the user logged in with the correct password,
Failed indicates that a login was attempted with an incorrect password.
• Logged In - the date and time when they logged in.
• Logged Out - the date and time when they logged out.

Note: If a non-existent User Nam e is entered during login a failed login attempt is recorded. Not
Found is entered in the Full Nam e field of the Login History, and the incorrectly entered
User Nam e is also recorded.

Note: There is no limit to the size of the Login History.

 Print button: Click this button to print all of the information currently held in the
Login History.
 Archive button: Click this button to export the contents of the current tab to a
comma-separated (CSV) or raw text file, then the contents are removed.
 34 . Syngistix User Setup Software Guide

Audit Trail
The software provides the Security audit trail which is a history of login attempts and an
audit trail of actions performed in the ES Setup applications. It records all changes to security
settings in compliance with 21 CFR Part 11. All changes to users, groups, password settings,
login history and signature points are recorded. It also records when the Login History or
Audit Trail have been exported and cleared.

3. In the User Setup dialog box, double-click Users & Groups.

The Users, Groups, Password Control, Login History, Audit Trail, and Summary dialog
box appears.
4. Select the Audit Trail tab.
The Audit Trail tab shows the following information for actions performed in User Setup:
• Function - the item that was changed, for example, Add New User.
• Previous Value - the state of the item before it was changed.
• Current Value - the new state.
• Full Name - the full name of the user who made the change.
• User Name - the login user name of the user who made the change.
• Computer - the name/ID of the computer used.
• Date Modified - the date and time when the action was performed.

Note: When permissions are added or deleted for a particular group, the Audit trail entry is a
number rather than the full permission name. To relate the number to a permission, select
Setup Users and Groups from the Administration menu and then select the Groups tab. Each
of the permissions listed has the related number against it. The permission and associated
number are also displayed in the summary
 Print button: Click this button to print the contents of the current tab.
 Archive button: Click this button to export the contents of the current tab to a comma-
separated (CSV) or raw text file.
The Audit Trail items will be exported to a CSV file, then removed.
 Summary . 35

Sum m ary
In the software, whenever you want to review your user, group, and password settings in
one summary report, you can view the Summary tab. To access it from the User Setup
window, click Users & Groups. In the Users, Groups, Password Control, Login History, Audit
Trail, and Summary dialog box, click the Summary tab.

The Summary tab displays a summary of the current security settings:

• Password control - it records login type, maximum password age, minimum
password age, minimum password length, password uniqueness, lockout count and
lockout duration.
• Permissions - it records the number of permissions and lists all the permissions
with their associated number.
• Users - it records the number of users. For each user it records the user name, full
name, status, last login, the group the user belongs to, and the permissions of that
group.
• Groups - it records the number of groups. For each group it records the group
name, the users in the group, and the group permissions.
 Print button: Click this button to prints the contents of the Summary tab.
 Export button: Click this button to export the contents of the current tab to a comma-
separated (CSV) or raw text file.
Data Folders

37
38 . Syngistix User Setup Software Guide
 Managing Data Folders . 39

M anaging Data Folders

In the software, data folders are locations where users store all files used in Syngistix. They
are initially displayed in the default location. You can set a new Base path then click the Set
base path button to store your data at a different location then the default. You could
always return to the default location settings by clicking the Defaults button.

To select Users
You can select All Users to have access to the Data Folders or Select user (then select a
user from the drop-down list) to have access to the Data Folders.

To add a data folder

When you have identified where you want data folders to be stored, you can specify their
location so that you can assign them to users.
1. From the User Setup window, click Data Folders.

2. Click browse to open the Browse for Folder dialog box.

3. Navigate to select your folder location.
The following example shows a browse to Workspaces.
 40 . Syngistix User Setup Software Guide

4. Click the Make new folder button and type the folder name.
5. Click OK to close the Browse for Folder dialog.
6. Click Apply to close the Data Folders dialog.

I m portant: If you Browse For a Folder and delete it, if you click the Defaults button it will bring
back the folder but not the files that were in that folder.

To delete a data folder

When a specific data folder is no longer required, you can delete it from the list of available
data folders.

Note: If you delete a default folder, the software will add that default folder back automatically
when you reset the base path; however, user data that were under that folder remain
deleted.
1. From the User Setup window, click Data Folders.

2. Click browse to open the Browse for Folder dialog box.

3. Navigate to select your folder location.

 Managing Data Folders . 41

4. Select the folder then press the Delete key on your keypad (or right-click and select
Delete from the pop-up menu).
5. Click OK to close the Browse for Folder dialog.
6. Click Apply to close the Data Folders dialog.

W hat Are the Default Storage Locations for Syngistix

Data?
For ICP Syngistix Data stored locally:
Shared Data: C:\Users\Public\PerkinElmer Syngistix\ICP\Data\
Individual Data (Windows Login Users): C:\Users\[userid]\PerkinElmer Syngistix\ICP\Data\
Individual Data (PerkinElmer Login Users): C:\Users\Public\PerkinElmer
Syngistix\ICP\[userid]\Data\
For ICP Syngistix Data stored at an alternative location (Non-ES only):
Shared Data: S:\Users\Public\PerkinElmer Syngistix\ICP\Data\
Where S stands for the alternative storage location.
Individual Data (Windows Login Users): S:\Users\[userid]\PerkinElmer Syngistix\ICP\Data\
Individual Data (PerkinElmer Login Users): S:\Users\Public\PerkinElmer
Syngistix\ICP\[userid]\Data\
Where S stands for the alternative storage location.
Electronic Signatures (ES only)

43
44 . Syngistix User Setup Software Guide

M anaging Electronic Signatures (ES only)

From the User Setup window, click Electronic Signatures. Managing electronic signatures
at signature points is handled through the Electronic Signatures dialog.

The user must supply their user name and password to apply their signature. For the first
signature during a given session, both name and password require user entry. For
subsequent signatures during the same session the User name is pre-populated based on
last user name entered and only password entry is required to implement. A session lasts
until the user logs out, or until a preset amount of time has been reached as determined by
the Administrator. The original user is allowed to remain logged in to the application while
another user applies a signature. The person signing may be different from the person
currently logged in and using Syngistix at the bench. The two users may have different
permission levels within the application.
Electronic signatures are required for critical operations, such as those operations which
cause data to be collected, administer security, or cause modifications to protected files.
What is an electronic signature ?
An electronic signature as defined by 21 CFR Part 11 means a computer data compilation of
any symbol or series of symbols executed, adopted, or authorized by an individual to be the
legally binding equivalent of the individual's handwritten signature.
What is a signature point ?
A Signature Point is a point in the software that requires a signature. The Signature Points
are pre-defined. The user has to enter their User name, Password (if this option has been
selected) and Reason for saving the method. They may also be able to add additional
Comments if this option has previously been selected by the Administrator.
 Managing Electronic Signatures (ES only) . 45

What settings are available for a signature point ?

The list of Signature Points within the software are already defined. The Administrator is able
to define the settings (that is, whether a signature and comments are required) for each
Signature Point individually or apply the same settings to all Signature Points. In addition, the
Administrator defines the list of reasons that may have caused each Signature Point to occur.
The user then selects a reason from this pre-defined list in the Signature Point dialog.
A Signature Point will only require a signature if Signature required is selected. Otherwise,
the software will ignore the Signature Point and the user will not be prompted for a
signature.
To define settings for each signature point:
1. Select a Signature Point Name from the drop-down list.
2. Select the check box if a Signature is required and if you want to Prompt for
comments.
When the Signature Point dialog is displayed in the software, the user will be prompted
to select a reason. For example, if they are rejecting data because they used the wrong
method, they would select wrong method implemented from the drop-down list of
available reasons . The list of reasons is also defined on this tab.
3. To add a new reason, click New and type a reason for that signature point.
You can create many reasons for a signature point. You can also Edit or Delete a
reason.
4. Click Update All... if you want to update all signature points.
The Update All Signature Points dialog appears.
46 . Syngistix User Setup Software Guide

5. Make you selection for Require Signature and Prompt For Comments then click
OK.
6. When done click Apply or click OK to save your entries and exit the dialog.

How do I add a reason for a signature point ?

1. Select the Name of the Signature Point to which you wish to add a new reason.
2. Click New.
The New Reason dialog is displayed.
3. Enter the new reason and click OK.
The reason is added to the list of reasons for the Signature Point.

How do I edit a reason for a signature point ?

1. Select the Reason to edit from the list in the Text field.
2. Click Edit.
The Edit Reason dialog is displayed.
3. Edit the Reason and click OK.
The Edit Reason dialog closes and the updated reason appears in the Text field. The
changes are recorded in the Audit trail.

How do I delete a reason for a signature point ?

1. Select the Reason to delete from the list in the Text field.
2. Click Delete.
A message is displayed asking to confirm the deletion.
3. Click OK to confirm.
The Reason is deleted from the Text field. The changes are recorded in the Audit trail.

How do I reorder the reasons listed for a Signature P oint ?

The order of the reasons in the Text field is the order in which the reasons will appear in the
drop-down list that the user will see.
To reorder the list:
1. Select the Reason that you wish to move the position of.
2. Use the arrow keys on the right hand side of the list to move the Reason up or down
as required.
Em ail Setup

47
48 . Syngistix User Setup Software Guide
 Managing Email . 49

M anaging Em ail
From the User Setup window, click Email Setup, the Email/Text dialog appears. Here you
add or modify Email settings from the Email Setup button.

Note: When updating an Email address in this User Setup application, the main Syngistix
application reads it as a new Email so you will need to re-select it under Notifications. Always
make sure to try a test Email first.

To Setup Em ail/ Text

1. Enter the SMTP host.
Your IT administrator should provide SMTP (Simple Mail Transfer Program) address for
your location.
2. Enter a From address.
3. Add an Email/Text address.

To add an em ail address

1. Click the Add button.
The Add Email/Text address dialog appears.

2. Select the Email Notification type.

3. Enter an Email address.
4. Optionally enter the Recipient name if desired.
5. Click OK when done.
50 . Syngistix User Setup Software Guide

To add a text address

Depending on the phone service provider, using text messages as an Email requires a
different format. The process works via an Email to SMS gateway. An SMS Gateway enables
a computer to send and receive SMS text messages to and from a SMS capable device over
the global telecommunications network (normally to a mobile phone). The SMS Gateway
translates the message sent, and makes it compatible for delivery over the network to be
able to reach the recipient.
As long as you know the phone number of the recipient in question and the name of their
service provider you can easily locate an appropriate gateway address for forwarding your
message.
1. Click the Add button.
2. Select the Text Address Notification type.
3. Enter the 10-digit Phone number of the person you’re trying to reach.
4. Entered the service Provider address.
Here is a list of some of the some of the most common service providers in the United
States and their corresponding gateway addresses.
Carrier SMS Gateway Domain
Altel [insert 10-digit number]@message.altel.com
AT&T [insert 10-digit number]@txt.att.net
Boost Mobile [insert 10-digit number]@myboostmobile.com
Sprint [insert 10-digit number]@messaging.sprintpcs.com
T-Mobile [insert 10-digit number]tmobile.net
U.S. Cellular [insert 10-digit number]@email.uscc.net
Verizon [insert 10-digit number]@vtext.com
Virgin Mobile [insert 10-digit number]@vmobl.com
Republic Wireless [insert 10-digit number]@text.republicwireless.com

5. Optionally enter the Recipient name if desired. Here is an example.

6. Click OK when done. The address appears in the Email/Text Setup dialog.
N otifications

51
52 . Syngistix User Setup Software Guide
 Managing Notifications . 53

M anaging N otifications
In the ES and non-ES software, Event Notifications are used to notify a person or persons
by email or text message about an event. Some examples that trigger events can be;
maximum number of failed login attempts reached or password reset, as well as those listed
in the main application.

The Emails listed are those set in the Email Setup dialog.
To add or remove Email addresses click the Email Setup button, select the address to be
removed,then click Remove. The Event Log captures that an email was sent.
54 . Syngistix User Setup Software Guide
Settings

55
56 . Syngistix User Setup Software Guide
 Managing Settings . 57

M anaging Settings
From the User Setup window, click Settings, the Settings dialog appears. Here you set an
application Lockout Time, Enable Remote Access (non-ES only), turning watermark for an
uncontrolled document on or off (ES only).

Application Lockout Time:

The Administrator can set the Automatic lockout time from 1 to 999 minutes. This is
intended for when a user leaves the computer and the program continues to run. Each
Syngistix application monitors the specified idle time, and all applications will lock when the
specified idle time has been reached by inactivity on the entire Syngistix application by
mouse or keyboard. All aspects of the software which were running in the background before
the lockout shall continue to run uninterrupted. After lockout, authentication of credentials is
required.
When Syngistix is idle for the set Time to lockout in minutes, the application is locked, and
the user is required to enter their credentials to gain access. The default idle time before
lockout is 5 minutes. The administrator sets the number of idle minutes before lockout.
• PerkinElmer login dialog displays automatically.
• The original user remains logged in until a new user is validated by credentials.
• If a new user fails to login, the original user remains logged in, and the application
remains locked.
• If the maximum number of unsuccessful login tries is reached, the administrator
notification email is triggered.
• Upon successful authentication, access will be regained for all applications.
Enable remote access (non-ES only)
When running Syngistix in the non-ES mode, this allows a remote client to connect and
control Syngistix. The Administrator controls access to this function by selecting the check
box Enable remote access.
58 . Syngistix User Setup Software Guide

Server IP address: Select the IP address of the computer running Syngistix.

Port: The port number used to connect to Syngistix.
When Remote Access is enabled, an icon displays in the Syngistix Status Panel showing the
current connection status.
Uncontrolled document watermark (ES only):
If you have the ES Tools application, you can select to turn the Uncontrolled Document
watermark on or off for all printouts by checking (on) or unchecking (off) this check box.