Thermo Fisher Scientific SAE Administrator Console User guide

For Research Use or Manufacturing of Cell, Gene, or Tissue- Based

Products.

SAE Administrator Console

USER GUIDE

for use with Cell and Gene Therapy Instrumentation

Publication Number MAN0029600

Revision A.0

Life Technologies Holdings Pte Ltd | Block 33 | Marsiling Industrial Estate Road 3 | #07-06, Singapore 739256

For descriptions of symbols on product labels or product documents, go to thermoﬁsher.com/symbols-deﬁnition.

Revision history:MAN0029600 A.0 (English)

Revision Date Description

A.0 13 September

2023 New document for SAE Administrator Console for use with Cell and Gene Therapy Instrumentation.

The information in this guide is subject to change without notice.

DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE

LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR

ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.

NOTICE TO PURCHASER: DISCLAIMER OF LICENSE: Purchase of this software product alone does not imply any license under any

process, instrument or other apparatus, system, composition, reagent or kit rights under patent claims owned or otherwise controlled by

Thermo Fisher Scientiﬁc, either expressly, or by estoppel.

TRADEMARKS: All trademarks are the property of Thermo Fisher Scientiﬁc and its subsidiaries unless otherwise speciﬁed.

Contents

■CHAPTER1Overview and security requirements ............................... 5

Overview ....................................................................... 5

Network and password security requirements ...................................... 5

Information about 21 CFR Part11 ................................................. 6

Administrator overview ........................................................... 6

■CHAPTER2Manage SAE user accounts and roles ............................. 7

Install Rotea™ instrument softwareproﬁles ......................................... 7

Determine the logged inuser ..................................................... 9

Create a useraccount ........................................................... 9

Edit a useraccount ............................................................. 13

Disable (inactivate) a useraccount ............................................... 14

Activate a suspended useraccount .............................................. 14

Change password .............................................................. 14

Reset a forgotten password ..................................................... 16

Permissions and default user roles ............................................... 17

Permissions and default roles ............................................... 18

Generate, view, and print a user or role report ..................................... 20

■CHAPTER3Manage the system securityfunction ............................. 21

Access the system security function screen ....................................... 21

Conﬁgure account setup and securitypolicies ..................................... 21

Set up messagingnotiﬁcations .................................................. 24

■CHAPTER4Manage the auditfunction ......................................... 27

Use the Audit function screen ................................................... 27

Generate audit reports .......................................................... 28

Review the systemconﬁguration ................................................. 29

Review the actionlog ........................................................... 30

View audit histories from the Audit History drop-downmenu ........................ 30

Archive and restore audit record ................................................. 32

Export audit records ............................................................ 32

SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation 3

■CHAPTER5Manage the e-signaturefunction .................................. 33

Access the e-signature screen ................................................... 33

Conﬁgure the meaning of the e-signatures ........................................ 34

New e-signaturemeaning ....................................................... 35

Delete an e-signaturemeaning ................................................... 35

Select the actions that requiree‑signature ......................................... 36

■CHAPTER6Manage the SAE export-importfunction ......................... 37

Export and import user, system security, audit, and e-signaturesettings .............. 37

Export user system security audit and e‑signaturesettings .......................... 37

Import user system security audit e‑signaturesettings .............................. 38

■CHAPTER7Conﬁgure user repositories ........................................ 39

User repository overview ........................................................ 39

Conﬁgure user repositories for SAE or external accountaccess ...................... 39

User respositorysettings ........................................................ 40

■APPENDIXASafety ............................................................... 42

■APPENDIXBDocumentation and support ...................................... 43

Customer and technical support ................................................. 43

Limited product warranty ........................................................ 43

Contents

4SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation

Overview and security requirements

Overview

The Security, Audit, and Electronic Signature (SAE) Administrator Console (Admin Console) is

available for many instruments and software from Thermo Fisher Scientiﬁc, including, but not limited

to, QuantStudio™, Attune™ NxT, Countess™ 3 and 3 FL instruments, CTS™ Rotea™ Counterﬂow

Centrifugation System, Xenon™ electroporation instrument, and iBright™ imaging systems. This guide

describes the procedures that an administrator performs to conﬁgure and manage the SAE features of

the CTS™ Rotea™ Counterﬂow Centrifugation System.

This system is used as an example of a Cell Therapy System and its use with the SAE Admin

Console. User interaction with the SAE Admin Console is described in the CTS™ Rotea™ Counterﬂow

Centrifugation System User Guide (Pub.No.MAN0018908).

Use of the Rotea™ SAE software requires:

•CTS™ Rotea™ Counterﬂow Centrifugation System (Rotea™ instrument with compatible ﬁrmware

versions and Thermo Fisher Scientiﬁc provided computer)

Network and password security requirements

The network conﬁguration and security settings of your laboratory or facility (such as ﬁrewalls, anti-

virus software, network passwords) are the sole responsibility of your facility administrator, IT, and

security personnel. SAE software should be installed on a server with a static IP address in a network

accessible by the Rotea™ instrument. If external or network drives are connected to the software, it is

the responsibility of your IT personnel to ensure that such drives are conﬁgured and secured correctly

to prevent data corruption or loss. It is the responsibility of your facility administrator, IT, and security

personnel to prevent the use of any unsecured ports (such as USB, Ethernet) and ensure that the

system security is maintained. Thermo Fisher Scientiﬁc strongly recommends that you maintain unique

passwords for all accounts in use on this product. All passwords should be reset upon ﬁrst sign-in

into the product. Change passwords according to your organization's password policy. It is the sole

responsibility of your IT personnel to develop and enforce secure use of passwords.

1

SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation 5

Information about 21 CFR Part 11

21 CFR Part 11 is a regulation that describes the criteria for acceptance by the FDA for electronic

records and electronic signatures. Part 11 is composed of procedural and technical requirements.

Procedural requirements are the standard operating procedures instituted by the end user, and

technical requirements are the technical characteristics of the compliance management software used.

The CTS™ Rotea™ SAE software consists of:

•SAE Administrator Console— Used to conﬁgure the Security, Audit, and e-Signature settings on

SAE module.

•Rotea™ SAE license— Used to activate the SAE settings for the Rotea™ instrument.

•Rotea™ SAE software module – Used to run the Rotea™ instrument in SAE mode.

The combination of this technical oering does not guarantee 21 CFR part 11 compliance alone.

Note: Compliance is the consequence of the end user’s work process and systems used.

Administrator overview

The SAE Admin Console is a component of the Rotea™ instrument System 21 CFR Part 11 support

software that allows you to conﬁgure the Rotea™ instrument to meet speciﬁc requirements. The SAE

Admin Console provides the following functionality:

•System security – Controls user access to the software. One default Administrator user account is

provided with full privileges. Additional user accounts can be user-deﬁned.

•Auditing – Tracks actions performed by users, and changes to the SAE module settings. The

software automatically audits actions silently. The auditing function provides reports for audited

SAE module changes and actions.

•Electronic signature (e-signature) – Determines which actions need approval and which role or roles

need to provide this approval.

Chapter1Overview and security requirements

Information about 21 CFR Part 11

1

6SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation

Manage SAE user accounts and

roles

Install Rotea™ instrument software proﬁles

Note: Installation of the instrument software proﬁles will be performed at the initial installation of the

Rotea™ instrument software by a ﬁeld service engineer.

The Rotea™ instrument application proﬁle is available for download

from https://www.thermoﬁsher.com/us/en/home/technical-resources/software-downloads/rotea-

counterﬂow-centrifugation-system.html.

1. Download the Rotea™ instrument application proﬁle (.dat ﬁle)

2. In the SAE Admin Console, go to Settings and click on Manage Application Proﬁles.

3. Click Install Application Proﬁle at the bottom of the page.

2

SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation 7

4. Select the Choose File option in the pop-up window to select and open the data ﬁle for the

Rotea™ dat ﬁle. The selected ﬁle name will appear by the side of the Select File option in the

pop-up window.

Note:

·SAE Admin Console only supports one proﬁle version at a time.

·SAE Admin Console will prompt for veriﬁcation on the ﬁle being use for installation (If the version

number is higher than the current version installed, the software will ask if the user wants to

upgrade the proﬁle version before installing).

·There is no impact to audit data upon installing a new proﬁle version.

5. Select Verify Data File and then select Install.

6. (Optional) Select Rotea SAE from the list and select View Details to see the application details.

Chapter2Manage SAE user accounts and roles

Install Rotea™ instrument software proﬁles

2

8SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation

Determine the logged in user

The name of the logged in user is displayed in the top-right corner of the SAE Admin Console window.

Note: There is a default Administrator role used in the software. Users can create a new Administrator

role but only an existing Administrator role can create one. For example, a ‘Administrator2’ role can only

be created by the default ‘Administrator’ role.

Create a user account

1. In the Users tab, click Create, then enter the username, password, ﬁrst name, (optional) middle

initial (MI), and last name. The ﬁeld limits are speciﬁed in the system security function settings.

Chapter2Manage SAE user accounts and roles

Determine the logged in user 2

SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation 9

Note: First name, MI (middle initial), and last name are used to create the user full name, which is

displayed in the System Conﬁguration audit records under Audit History in SAE Admin Console.

Chapter2Manage SAE user accounts and roles

Create a user account

2

10 SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation

Note: You cannot change the username after you save the user account. A username can be

deactivated if a team member no longer requires access, however that speciﬁc username will no

longer be available for use. This is done to ensure unique account identities are preserved for

traceability.

2. Select User must set new password at next sign in to require the user account to specify a new

password at ﬁrst login. This will occur upon that user's account sign in the ﬁrst time they log into

the Rotea™ SAE module.

Note: The user account password automatically expires after the number of days speciﬁed in the

system security function settings.

Chapter2Manage SAE user accounts and roles

Create a user account 2

SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation 11

3. Select the user role from the Role dropdown menu.

Note: New roles can be added per the users preference.

4. Leave the status set to Active.

Chapter2Manage SAE user accounts and roles

Create a user account

2

12 SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation

5. (Optional) Enter phone, email (for information only), and comments.

Note: Any information entered into the SAE Admin Console software are updated to an encrypted

database on the local computer. The application itself does not delete this information. Removal

or deletion of this information is the responsibility of the users IT department information security

policies.

6. Click Save.

Edit a user account

1. In the Users tab, select a user account, then click Edit.

2. Edit the settings as desired.

Note: You cannot edit the username of an existing user and you cannot delete an existing

account. A username can be deactivated if a team member no longer requires access, however

that speciﬁc username will no longer be available for use. This is done to ensure unique account

identities are preserved for traceability.

3. Click Save.

Chapter2Manage SAE user accounts and roles

Edit a user account 2

SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation 13

Disable (inactivate) a user account

1. In the Users tab, select a user account, then click Edit.

2. Change the Status from ACTIVE to INACTIVE.

3. Click Save.

4. To activate this user, edit the account and change the status to ACTIVE.

Activate a suspended user account

1. In the Users tab, select a user account, then click Edit.

2. Change the Status from SUSPENDED to ACTIVE.

Note: ‘SUSPENDED’ is dierent from ‘DEACTIVATED’. The dierence is that ‘SUSPENDED’

means the user account is temporarily unavailable. An example is the user login fails multiple

successive attempts and now the status is changed to ‘SUSPENDED’. A ‘DEACTIVATED’ status is

used for individuals who are no longer responsible or allowed to have any instrument interaction.

3. Click Save.

Change password

1. From the dropdown list, select Change Password.

Note: You can access the Change Password dialog box from any tab.

Chapter2Manage SAE user accounts and roles

Disable (inactivate) a user account

2

14 SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation

2. Enter the old password.

3. Enter a new password, conﬁrm the new password, then click Update.

Note: The following symbols cannot be used in the password as they are not compatible with the

Rotea™ instrument: = + , . ( ) { } ' " ; : ` ~

Chapter2Manage SAE user accounts and roles

Change password 2

SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation 15

Reset a forgotten password

Note: There is no password recovery option in SAE Admin Console. The password must be reset. It

is recommended that a second Administrator role be created as a backup to the primary Administrator

role.

1. In the Users tab, select the aected user account, then click Edit.

2. Enter a replacement password for the user account, then re-enter the password for conﬁrmation.

Note: A temporary password will require the User to set a new password at next sign in.

3. Check the User must set new password at next sign in.

4. Click Save.

Chapter2Manage SAE user accounts and roles

Reset a forgotten password

2

16 SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation

Permissions and default user roles

To determine the permissions for a default role or to edit them, select the role then click Edit.

The following table shows all user-conﬁgurable permissions and the settings for the default user

accounts.

Chapter2Manage SAE user accounts and roles

Permissions and default user roles 2

SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation 17

Permissions and default roles

Permissions Available roles

Category Function Administrator

Login Log into Rotea SAE Yes

Settings Set Protocol Folder Yes

Run Settings Manage Run Settings Yes

Manage Run Reasons Yes

Run Browse Protocol Yes

Initiate Protocol Yes

Rescan Kit Yes

Start Protocol Yes

Chapter2Manage SAE user accounts and roles

Permissions and default user roles

2

18 SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation

(continued)

Permissions Available roles

Run Start Protocol from selected step Yes

Pause Run Yes

Skip Step Yes

Stop Run Yes

Setting Change Password Yes

Conﬁgure SAE Console software Conﬁgure SAE Console software Yes

Chapter2Manage SAE user accounts and roles

Permissions and default user roles 2

SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation 19

Generate, view, and print a user or role report

1. In the Users or Roles tab, click Report. The user report, or role report, downloads to the default

location which will be the Downloads folder for the computer.

Note: There is not an option to change this ﬁle download location.

2. Click on the download report tab in the bottom of the screen to view the report in a new tab of the

web browser or to open the location of the downloaded report .pdf on your computer.

3. Use the options available in the .pdf viewer to save and print the report.

4. Close the report.

Chapter2Manage SAE user accounts and roles

Generate, view, and print a user or role report

2

20 SAE Administrator Console User Guide for Cell and Gene Therapy Instrumentation

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Thermo Fisher Scientific SAE Administrator Console User guide

Thermo Fisher Scientific SAE Administrator Console User guide

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