sae administrator console v2

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SAE Administrator Console v2 USER GUIDE for v2.0 or later for use with: SeqStudio Data Collection Software v1.2 and later QuantStudio 7 Pro Real-Time PCR System with QuantStudio Design and Analysis Software v2 QuantStudio Absolute Q Digital PCR Software v6.1.0 Publication Number MAN0017468 Revision D.0

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Page 1: SAE Administrator Console v2

SAE Administrator Console v2USER GUIDE

for v2.0 or later

for use with:SeqStudio™ Data Collection Software v1.2 and laterQuantStudio™ 7 Pro Real-Time PCR System with QuantStudio™ Design andAnalysis Software v2QuantStudio™ Absolute Q™ Digital PCR Software v6.1.0Publication Number MAN0017468

Revision D.0

Page 2: SAE Administrator Console v2

Life Technologies Holdings Pte Ltd | Block 33 | Marsiling Industrial Estate Road 3 | #07-06, Singapore 739256For descriptions of symbols on product labels or product documents, go to thermofisher.com/symbols-definition.

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 BELIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH ORARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.

Important Licensing Information: These products may be covered by one or more Limited Use Label Licenses. By use of theseproducts, you accept the terms and conditions of all applicable Limited Use Label Licenses.

NOTICE TO PURCHASER: DISCLAIMER OF LICENSE: Purchase of this software product alone does not imply any license under anyprocess, instrument or other apparatus, system, composition, reagent or kit rights under patent claims owned or otherwise controlled byThermo Fisher Scientific, either expressly, or by estoppel.

Revision history: Pub. No. MAN0017468

Revision Date Description

D.0 4 October 2021 • Added information on static and dynamic IP addresses, and requirements if SAEAdministrator Console is installed on a separate computer to “SAE AdministratorConsole installation requirements” on page 8.

• Added information on the firewall ports that must be open on page 9.

• Added features and compatibility of SAE v2.1 and SAE v2.2 to “Compatibility ofSAE versions and application profiles” on page 9.

• Added URL information for Google™ Chrome™ and Internet Explorer™ to “Start theSAE Administrator Console” on page 12.

• Added content for the QuantStudio™ Absolute Q™ Digital PCR Software v6.1.0.

• Specified the settings that are not used if an external LDAP is used.

• Specified that the files are checksum protected.

C.0 2 June 2020 Added functions for using the SAE Administrator Console with the QuantStudio™ 7 ProReal-Time PCR System and the QuantStudio™ Design and Analysis Software v2.

B.0 3 January 2020 • Added content for the QuantStudio™ 7 Pro Real-Time PCR System and theQuantStudio™ Design and Analysis Software v2.

• Added network and password security requirements.

A.0 1 November 2019 New information for SAE Administrator Console v2.0. Adds functionality for theSeqStudio™ Genetic Analyzer, audit archival, instrument run logs, and configuration ofuser repositories.

TRADEMARKS: All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. Windows isa trademark of Microsoft Corporation.

©2021 Thermo Fisher Scientific Inc. All rights reserved.

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Contents

■ CHAPTER 1 Get started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Network and password security requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Network configuration and security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Password security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

SAE Administrator Console installation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Computer-to- SAE Administrator Console server connection . . . . . . . . . . . . . . . . . . . . . 8Minimum computer requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Firewall ports that must be open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Compatibility of SAE versions and application profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Features of SAE v2.1 and later . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

About the SAE Administrator Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10SAE module components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10View the terms of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Workflow: Configure the SAE module using the SAE Administrator Console . . . . . . . . . . . 11

Start the SAE Administrator Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12URL for the Google™ Chrome™ browser (recommended) . . . . . . . . . . . . . . . . . . . . . . . . 13URL for the Internet Explorer™ browser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Set up the SAE Administrator Console with application profiles . . . . . . . . . . . . . . . . . . . . . . 13

Optional SAE Administrator Console tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Set up SAE messaging notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Determine the signed-in user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Display the software version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Change your SAE user account password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Select the language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

■ CHAPTER 2 Configure the SAE module for the SeqStudio™

Genetic Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Enable SAE on the SeqStudio™ Genetic Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Disable SAE on the SeqStudio™ Genetic Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Default permissions and roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Default audit and e‑signature settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Audited objects and actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Actions and objects that require e‑signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Default audit and e‑signature reasons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

SAE Administrator Console v2.0 User Guide 3

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■ CHAPTER 3 Configure the SAE module for the QuantStudio™ 7 ProReal-Time PCR System and the QuantStudio™ Design and AnalysisSoftware v2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

SAE-enabled system components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Compatibility between SAE-enabled and SAE-disabled components . . . . . . . . . . . . . 22

Overview of the instrument features when the SAE module is enabled . . . . . . . . . . . . . . . . 23

Profiles when the SAE module is enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Enable SAE functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Configuring SAE Administrator Console application profiles . . . . . . . . . . . . . . . . . . . . . 24Enable SAE on the instrument and specify the SAE server (administrator only) . . . . . 24Connect to the SAE server in QuantStudio™ Design and Analysis Software v2 . . . . . 25Enable SAE functions in QuantStudio™ Design and Analysis Software v2 . . . . . . . . . 26

Disable SAE on the instrument (administrator only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Disable SAE functions in QuantStudio™ Design and Analysis Software v2 . . . . . . . . . . . . . 27

Sign in as a local administrator with SAE enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Change your SAE account password on the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

SAE Administrator Console functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Functions that are controlled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Functions that can be audited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Functions that can be signed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Default permissions and roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Dialog boxes in the SAE module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Sign a plate setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Enter an audit reason . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

View signing records for a plate file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

View audit records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Use the instrument when the SAE server is offline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

E-signature requirements to start a run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Signing in after automatic screen locking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

SAE error messages and actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Contents

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■ CHAPTER 4 Configure the SAE module for QuantStudio™ Absolute Q™

Digital PCR Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Overview of the QuantStudio™ Absolute Q™ Digital PCR Software functionalitywhen SAE is enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

SAE functions not supported by the QuantStudio™ Absolute Q™ DigitalPCR Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Enable SAE functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Configure SAE Administrator Console application profiles . . . . . . . . . . . . . . . . . . . . . . . 42Connect to the SAE server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Enable SAE functions in QuantStudio™ Absolute Q™ Digital PCR Software . . . . . . . . 43

Sign into QuantStudio™ Absolute Q™ Digital PCR Software using an SAE account . . . . . . 43

Sign out of the software using an SAE account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Change your SAE account password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Default permissions and roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Specify audit reason . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

View audit records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Export audit records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Sign data in the software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

View e-signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Disable SAE functions in QuantStudio™ Absolute Q™ Digital PCR Software . . . . . . . . . . . . 47

■ CHAPTER 5 Manage SAE user accounts and roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Create an SAE user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Edit an SAE user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Activate a suspended SAE user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Disable (inactivate) an SAE user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Reset an SAE user account password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Manage roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50Create a role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50Edit a role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Delete a role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

View or print a user or role report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

■ CHAPTER 6 Manage the system security function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Enable or disable the system security function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Configure account setup and security policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Contents

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■ CHAPTER 7 Manage the audit function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Enable or disable the audit function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Select items to audit and set the Audit Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Configure audit reason settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

View audit logs (audit history) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56View the System Configuration audit log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56View the Action Records audit log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56View Application Object Records audit log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57View Instrument Run Records audit log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Archive and restore audit records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Archive audit records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58View or export archived audit records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Restore archived audit records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

■ CHAPTER 8 Manage the e-signature function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Enable or disable the e‑signature function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Select the actions that require e-signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Configure the meanings of e-signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61Add an e‑signature meaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61Delete an e‑signature meaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

■ CHAPTER 9 Advanced configuration options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Export and import user, system security, audit, and e‑signature settings . . . . . . . . . . . . . . 62

Configure user repositories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63User repository overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63Configure user repositories for SAE or external account access . . . . . . . . . . . . . . . . . 64User repository settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64User or administrator sign-in with LDAP or federated user repositories . . . . . . . . . . . 65

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Contents

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Get started

■ Network and password security requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

■ SAE Administrator Console installation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

■ Compatibility of SAE versions and application profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

■ About the SAE Administrator Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

■ Workflow: Configure the SAE module using the SAE Administrator Console . . . . . . . . . . . . . . . . . . 11

■ Start the SAE Administrator Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

■ Set up the SAE Administrator Console with application profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

■ Optional SAE Administrator Console tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Network and password security requirements

Network configuration and security

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, andsecurity personnel. This product does not provide any network or security configuration files, utilities, orinstructions.

If external or network drives are connected to the software, it is the responsibility of your IT personnelto ensure that such drives are configured and secured correctly to prevent data corruption or loss. Itis the responsibility of your facility administrator, IT, and security personnel to prevent the use of anyunsecured ports (such as USB, Ethernet) and ensure that the system security is maintained.

Password security

Thermo Fisher Scientific strongly recommends that you maintain unique passwords for all accounts inuse on this product. All passwords should be reset upon first sign in to the product. Change passwordsaccording to your organization's password policy.

It is the sole responsibility of your IT personnel to develop and enforce secure use of passwords.

1

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SAE Administrator Console installation requirementsThe SAE Administrator Console can be installed on a computer purchased from Thermo FisherScientific or a customer-supplied computer.

If a customer-supplied computer is used, there are minimum specifications. See “Minimum computerrequirements” on page 8.

Only one SAE Administrator Console can be installed on one computer. Multiple applications canconnect to the single instance of the SAE Administrator Console.

If the SAE Administrator Console is installed on a different computer than the instrument or software, astatic IP address is recommended. If using a dynamic IP address, enter the Server hostname insteadof the IP address for the SAE Connection Settings to prevent the loss of a connection. Consult yournetwork administrator for help with checking the IP address configuration.

Note: An application software can be installed on:

· The same computer as the SAE Administrator Console (recommended for a single application)

· A different computer than the SAE Administrator Console (recommended for multiple applications)

Computer-to- SAE Administrator Console server connection

If SAE is installed on a separate computer, the time difference between the instrument or software andthe SAE Administrator Console must be less than five minutes in order to establish the connection. Ifthe time difference is more than five minutes, the instrument will display an error message.

Minimum computer requirements

The following are the minimum specifications for a customer-supplied computer:

• Operating system—Windows™ 10 (64‑bit)

• Memory—16 GB RAM minimum

• Monitor—1280 × 1024 resolution or higher

• Hard drive—500 GB minimum free space

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Firewall ports that must be open

The following ports must be open for the operating system on an SAE computer.

Version Ports Condition

SAE v2.0 8201

• Instrument-to-SAEAdministrator Console serverconnection

• Computer-to-SAEAdministrator Console serverconnection[1]

SAE v2.1 and later 8443

• Instrument-to-SAEAdministrator Console serverconnection

• Computer-to-SAEAdministrator Console serverconnection[1]

[1] If the software is installed on a different computer than the SAE Administrator Console.

Compatibility of SAE versions and application profilesApplication profiles created with earlier versions of the SAE software can be used with later versions ofthe SAE software. For example, a profile created with SAE v2.0 can be installed on SAE v2.1 or later.Profiles created with newer SAE servers are not supported by earlier versions. For example, a profilecreated with SAE v2.2 cannot be installed on SAE v2.1 or earlier.

The compatibility of SAE versions and applications are listed in the following table:

Application SAE version

SeqStudio™ Genetic Analyzer v1.2 and later v2.0

QuantStudio™ 7 Pro Real-Time PCR System withQuantStudio™ Design and Analysis Software v2

v2.0, v2.1, v2.2

QuantStudio™ Absolute Q™ Digital PCRSoftware v6.1.0

v2.2

Features of SAE v2.1 and later

Features of SAE v2.1 and v2.2 are listed in the following table:

SAE version Feature

SAE v2.1 Converts the URL to HTTPS, see “Start the SAEAdministrator Console” on page 12

SAE v2.2 Provides the option to select the language, see“Select the language” on page 15

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About the SAE Administrator ConsoleThe SAE Administrator Console is the tool that you use to configure the Security, Audit, and ElectronicSignature (SAE) module. The SAE module can be configured to meet specific requirements for security,audit, and e-signature.

In the SAE Administrator Console, a software or instrument that is configured for the SAE module iscalled an "application". Example applications include the SeqStudio™ Data Collection Software or theQuantStudio™ Design and Analysis Software v2.

For information on using the SAE Administrator Console with a specific application, see the chapter forthe application.

The SAE module can be configured to provide the following functionality:

Function Description

System security Controls user access to an application. A default user account assigned the Administratorrole is provided at installation. You can set up additional SAE user accounts andpermissions.

Auditing Tracks actions performed by users and changes to the SAE module settings. The SAEmodule automatically audits some actions silently. You can perform the following functions:

• Select to audit specific user actions, and specify the audit mode.

• Generate reports for audited user actions and SAE module changes.

• Generate reports for software or instrument actions and runs.

Electronic signature(e‑signature)

Determines if users are required to fulfill signature requirements before performing specificfunctions. You can perform the following functions:

• Configure e‑signature so that a user can start a run only if the associated data aresigned.

• Configure each e-signature event to require multiple signatures and to require userswith specific roles to sign.

SAE module components

The SAE module is a client-server software configuration that includes three components:

• SAE Administrator Console—Tool that is used by an SAE administrator to configure the SAEmodule.

• SAE server (server)—Service that runs in the background and stores SAE settings, user accounts,audit records, and e-signature records. By default, the SAE server is installed on the samecomputer as the SAE Administrator Console.

• SAE screens (client)—Screens that are displayed in an application (sign in, audit, and e‑signature),for example, the SeqStudio™ Data Collection Software, and that require user input.

View the terms of use

To view the terms of use, click Settings4About terms of use.

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Workflow: Configure the SAE module using the SAEAdministrator Console

Set up the SAE Administrator Console (before first use)

Start the SAE Administrator Console (page 12)

Set up the SAE Administrator Console with application profiles(page 13)

Enable SAE in the application(See the chapter for the specific application)

Configure the SAE module (as needed)

Chapter 6, Manage the system security function and Configureaccount setup and security policies (page 52)Complete this step of the workflow to control restrictions and system security policies for all SAEuser accounts.

Chapter 7, Manage the audit functionComplete this step of the workflow to select actions to be audited and view audit reports.

Chapter 8, Manage the e-signature functionComplete this step of the workflow to select actions that require e‑signature and view e‑signaturereports.

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Start the SAE Administrator Console

Note: In SAE Administrator Console v2.1 or later, the software will automatically convert the URL tohttps://localhost:8443/admin-console/login.

For more information, see “URL for the Google™ Chrome™ browser (recommended)” or “URL for theInternet Explorer™ browser” on page 13.

Contact Support for additional questions.

1. In the Windows™ desktop, click Start4Applied Biosystems4SAE Admin.

2. Enter the Administrator User Name and Password, then click Sign in.

If messaging notifications are enabled (see page 14), the Event Notifications dialog box isdisplayed.

IMPORTANT! The administrator password cannot be recovered after it is set. The software mustbe uninstalled, then reinstalled.

3. You can do either of the following in the Event Notifications dialog box:

• Select the checkboxes for the events, then click Acknowledge to remove the selected eventsfrom the list.

• Click Close to close the dialog box and retain the events in the list.

The SAE Administrator Console main screen is displayed. Click the navigation tabs to displaydifferent screens in the software.

1

1 Navigation tabs

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URL for the Google™ Chrome™ browser (recommended)

If the URL of the SAE Administrator Console has not been added as a trusted site in the Google™

Chrome™ browser, "Not secure" is displayed in the URL bar.

The user can log in.

If the URL of the SAE Administrator Console is added as a trusted site in the Google™ Chrome™

browser, the same user interface will be displayed as if the URL was not added as a trusted site.

If a certificate is installed in Internet Explorer™, "This site is not secure" is not displayed.

Note: The certificate is installed in Internet Explorer™.

URL for the Internet Explorer™ browser

If the URL of the SAE Administrator Console has not been added as a trusted site in the InternetExplorer™ browser, "This site is not secure" is displayed.

Click More information4Go on to the webpage (not recommended) to proceed.

The SAE Administrator Console will be launched with Certificate error displayed in the URL bar. Theuser can log in.

If the URL of the SAE Administrator Console is added as a trusted site in the Internet Explorer™ browser,the same user interface will be displayed as if the URL was not added as a trusted site.

If a certificate is installed in Internet Explorer™, "This site is not secure" is not displayed.

Set up the SAE Administrator Console with applicationprofiles

An application profile contains default SAE Administrator Console settings for an application. Exampleapplications include the SeqStudio™ Data Collection Software or the QuantStudio™ Design and AnalysisSoftware v2.

Before you can use the SAE Administrator Console to configure the SAE module for an application,you must install a profile for the application. Each application has its own application profile, or set ofapplication profiles. After you add an SAE profile, you can add other profiles.

1. In the SAE Administrator Console main screen, select Settings4Manage ApplicationProfiles4Install Application Profile, then select the application profile (.dat file) of interest.

2. Select Verify Data File4Install new application4Install.The application name and settings are added to the SAE Administrator Console.

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Optional SAE Administrator Console tasks

Set up SAE messaging notifications

You can specify when and how to be notified when specified events occur in the SAE AdministratorConsole.

1. In the SAE Administrator Console main screen, select Settings4Notifications.

2. In the Edit Notification Settings dialog box, select Notify at Administrator sign in for the eventsof interest.

3. (Optional) Select Notify by Email, then specify an email address.

4. Click Save.

Configure the SMTP server for email notifications

Configure the SMTP server so that the SAE Administrator Console can send email notifications.

1. In the SAE Administrator Console main screen, click the Settings tab.

2. Select Email Server.

3. In the SMTP Configuration dialog box, enter the following:

• SMTP host, SMTP port, and SMTP sender

Note: Select Authentication required if the SMTP server requires authentication.

• User Name and Password

Note: Select Use SSL if the SMTP server requires an encrypted channel connection.

4. Click Save.

Determine the signed-in user

The name of the signed-in user is displayed in the top-right corner of the SAE Administrator Consolemain screen.

Display the software version

1. In the SAE Administrator Console main screen, click the Settings tab.

2. Select About.The SAE Administrator Console software version is displayed.

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Change your SAE user account password

1. At the top right of any screen, click , then select Change Password.

2. Enter the old password.

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

Select the language

Different languages are available in SAE Administrator Console v2.2.

• In the SAE Administrator Console main screen menu bar, click the language in the languagedrop-down list.

• To select a different language, click the language at the top right of the Sign in screen.The webpage will reload automatically.

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Configure the SAE module for theSeqStudio™ Genetic Analyzer

■ Enable SAE on the SeqStudio™ Genetic Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

■ Default permissions and roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

■ Default audit and e‑signature settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Enable SAE on the SeqStudio™ Genetic Analyzer

When the SAE module is enabled:

• The SAE module controls the access to and the available functions for the SeqStudio™ DataCollection Software.

• The SAE module does not affect SeqStudio™ Plate Manager desktop or cloud.

• The Connect cloud-based platform and remote monitoring functions are disabled in theSeqStudio™ Data Collection Software.

Before you enable SAE, install the SAE Administrator Console on a computer with a static IP address.Consult your network administrator for help with checking the IP address configuration.

This procedure requires a local instrument administrator profile and an SAE account with administratorrole.

1. Sign in to the instrument with a local instrument administrator profile.

2. Touch Settings4SAE.

3. Touch Connection settings, then enter the Server IP and Port of the computer on which the SAEAdministrator Console is installed.

IMPORTANT! Specify a computer with a static IP address.

4. Touch Enable SAE.

5. Enter your SAE administrator account user name and password, then touch Enable SAE.

The instrument will restart automatically.

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Disable SAE on the SeqStudio™ Genetic Analyzer

This procedure requires an SAE account with administrator role.

1. Sign in to the instrument with an SAE account with administrator role.

2. Touch Settings4SAE.

3. Touch Disable SAE.

4. Enter your SAE administrator account user name and password, then touch Disable SAE.

Default permissions and rolesThe SAE module provides the following default permissions and roles for the SeqStudio™ DataCollection Software. You can assign these default roles to SAE user accounts, or you can create andassign custom roles (see “Create a role” on page 50).

• Administrator

• Scientist

• Technician

IMPORTANT! SAE permissions for a role apply to all user accounts that are assigned to the role.

The default roles and associated user-configurable permissions are listed in the following table. You canalso double‑click the role in the Roles tab to display the list of permissions.

Note:

· Functions that are not listed in the following table are available to all roles.

· The No Privileges role is used by the SAE module when you set up user repositories. Do not assignthis role to an SAE user account.

Permissions Default roles

Category Function Technician Scientist Administrator

SAE Administrator Console

SecurityConfiguration

Configure security and auditing No No Yes

Audit History View action records No No Yes

View system configuration records No No Yes

View application object records No No Yes

View instrument run records No No Yes

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Permissions Default roles

Category Function Technician Scientist Administrator

SeqStudio™ Genetic Analyzer Data Collection Software

Setup Create or edit a plate setup Yes Yes Yes

AnalysisSettings

Create analysis settings Yes Yes Yes

Delete analysis settings Yes Yes Yes

Size Standard Create a size standard Yes Yes Yes

Delete a size standard Yes Yes Yes

Custom DyeSets

Create a dye set Yes Yes Yes

Import a dye set Yes Yes Yes

Delete a dye set Yes Yes Yes

Run Control a run: Start a run, pause a run, cancelthe current injection, cancel remaining injections

Yes Yes Yes

Manage injections: Perform re-injections,change the injection order, edit or deleteinjections

Yes Yes Yes

Run module Create or import a run module Yes Yes Yes

Delete a run module No Yes Yes

Kit Import a kit No Yes Yes

Calibration Perform a dye calibration Yes Yes Yes

Install run Perform an install run No Yes Yes

Instrumentconfiguration

Perform a firmware update No No Yes

Configure the network No No Yes

Change the instrument name No No Yes

Modify the date and time No No Yes

Securityconfiguration

Log in to timed-out user sessions No No Yes

Perform e-signing No Yes Yes

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Default audit and e‑signature settingsWhen SAE is enabled in the SeqStudio™ Data Collection Software, the SAE functions are set to thefollowing:

• Audit—Enabled by default, but can be disabled

• E‑signature—Enabled by default, but can be disabledBy default, no actions are set to require e‑signature.

Audited objects and actions

By default, the SAE module audits any changes made to the following objects in the SeqStudio™ DataCollection Software:

• Plate, which includes Injection, Injection Parameter, and Well

• Run Module, which includes Run Module Parameter

The Audit mode is set to Optional by default. An audit reason dialog box is displayed when an objectis changed, but a user can dismiss the dialog box without entering a reason.

To change the Audit mode, see Chapter 7, “Manage the audit function”.

The following user actions are audited silently (no audit reason dialog box is displayed), and you cannotchange the Audit mode:

• Enable or disable SAE functions in the SeqStudio™ Data Collection Software

• Sign in to or sign out of the SeqStudio™ Data Collection Software

• Start, pause, resume, or cancel an instrument injection or plate run

• Perform a dye calibration or an install run

• Perform cartridge maintenance: Refresh PDS or Fill Array

Actions and objects that require e‑signature

By default, no actions in the SeqStudio™ Data Collection Software are set to require e‑signature.

The action that can be set to require e‑signature is:

• Start run

The objects that can be set to require e‑signature are:

• Install run

• Dye calibration

• Plate setup

To set actions to require e‑signature and to set the number of signatures that are required, seeChapter 8, “Manage the e-signature function”.

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Default audit and e‑signature reasons

The SAE module is installed with the following default audit reasons and e‑signature reasons. Thesereasons can be selected by the user in the SeqStudio™ Data Collection Software for auditing ande‑signature.

To create additional reasons or modify reasons, see Chapter 7, “Manage the audit function” andChapter 8, “Manage the e-signature function”.

Default audit reasons:

• Manually edited

• Entry error

• Well anomaly

• Calculation error

• Need to change threshold

• Need to reanalyze

Default e‑signature reasons:

• Reviewed and approved install run

• Reviewed and approved dye calibration

• Reviewed and approved plate setup

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Configure the SAE module forthe QuantStudio™ 7 Pro Real-Time

PCR System and the QuantStudio™

Design and Analysis Software v2

■ SAE-enabled system components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

■ Overview of the instrument features when the SAE module is enabled . . . . . . . . . . . . . . . . . . . . . . 23

■ Profiles when the SAE module is enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

■ Enable SAE functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

■ Disable SAE on the instrument (administrator only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

■ Disable SAE functions in QuantStudio™ Design and Analysis Software v2 . . . . . . . . . . . . . . . . . . . 27

■ Sign in as a local administrator with SAE enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

■ Change your SAE account password on the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

■ SAE Administrator Console functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

■ Default permissions and roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

■ Dialog boxes in the SAE module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

■ Sign a plate setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

■ Enter an audit reason . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

■ View signing records for a plate file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

■ View audit records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

■ Use the instrument when the SAE server is offline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

■ E-signature requirements to start a run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

■ Signing in after automatic screen locking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

■ SAE error messages and actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

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SAE-enabled system componentsThe following system components can be used with SAE functions enabled:

• QuantStudio™ Design and Analysis Software v2

• QuantStudio™ 7 Pro Real-Time PCR System

• QuantStudio™ 7 Pro Real-Time PCR System plate file—SAE-enabled plate files are created in theQuantStudio™ Design and Analysis Software v2 with SAE enabled.

– If SAE is enabled in the QuantStudio™ Design and Analysis Software v2, you can only createplate files for the QuantStudio™ 7 Pro Real-Time PCR System.

– If SAE is enabled on the QuantStudio™ 7 Pro Real-Time PCR System, you cannot create or edita plate file from the instrument touchscreen.

• QuantStudio™ 7 Pro Real-Time PCR System data file—SAE-enabled data files are created on theQuantStudio™ 7 Pro Real-Time PCR System with SAE enabled.

We recommend enabling SAE for all system components (see “Enable SAE functions” on page 24). Ifone or more of the components have conflicting SAE status, some functions may not be available (see“Compatibility between SAE-enabled and SAE-disabled components” on page 22).

Compatibility between SAE-enabled and SAE-disabled components

We recommend enabling SAE for all system components (for more information, see “Enable SAEfunctions” on page 24). If one or more of the components have conflicting SAE status, some functionsmay not be available. See the following table for more information.

ComponentFunctionality with an SAE-enabled plate or data

fileFunctionality with an SAE-disabled

plate or data file

QuantStudio™ Design andAnalysis Software v2 withSAE enabled

• The file can be edited depending on SAEconfiguration.

• The audit trail is continued.

• The file is opened in read-onlymode.

• The file cannot be edited orsaved.

QuantStudio™ Design andAnalysis Software v2 withSAE disabled

• SAE-disabled files allowed—The file isopened and can be edited. The file can besaved as an invalid SAE file only.[1]

• QuantStudio™ 7 Pro Real-Time PCR Systemforbidden—The file cannot be opened.

The file can be opened, edited, andsaved.

QuantStudio™ 7 Pro Real-Time PCR System withSAE enabled

• The file can be opened from the run queue,a USB drive, or other sources.[2]

• The file cannot be edited.

• The audit record is continued.

The file cannot be opened.

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ComponentFunctionality with an SAE-enabled plate or data

fileFunctionality with an SAE-disabled

plate or data file

QuantStudio™ 7 Pro Real-Time PCR System withSAE disabled

• The plate file can be opened and edited.

• The file can be saved as an invalid SAE fileonly.[1]

• The file can be used to start a run, but thedata file will be an invalid SAE file.[1]

The file can be opened, edited, andsaved.

[1] Invalid SAE files contain incomplete audit records.[2] You cannot import plate files from the Connect cloud-based platform when the instrument has SAE enabled.

Overview of the instrument features when the SAE moduleis enabled

The following instrument features are not available when the SAE module is enabled:

• Facial authentication

• Voice commands

• Linking to the Connect cloud-based platform, including using a Connect cloud-based platformaccount to log in

• System templatesOnly SAE-enabled plate files that were created in the QuantStudio™ Design and Analysis Softwarev2 can be opened on the instrument.

Profiles when the SAE module is enabledAfter the SAE module is enabled on the instrument, the local instrument profiles and the Connectcloud-based platform profiles will not be available.

An account from the SAE Administrator Console must be used to sign in to the instrument when theSAE module is enabled. A local instrument administrator can sign in to the instrument to perform limitedadministrator functions.

The local instrument profiles and the Connect cloud-based platform profiles are available if the SAEmodule is disabled.

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Overview of the instrument features when the SAE module is enabled

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Enable SAE functions

Workflow

Enable SAE functions

Configuring SAE Administrator Console application profiles(page 24)

Enable SAE on the instrument and specify the SAE server(administrator only) (page 24)

Connect to the SAE server in QuantStudio™ Design and AnalysisSoftware v2 (page 25)

Enable SAE functions in QuantStudio™ Design and AnalysisSoftware v2 (page 26)

Configuring SAE Administrator Console application profiles

Note: Configuring application profiles in the SAE Administrator Console requires an SAE administratoraccount. See “Set up the SAE Administrator Console with application profiles” on page 13.

In the SAE Administrator Console, an application profile contains default settings for an application.Before using the SAE Administrator Console, an administrator must install, then configure profiles forthe following applications:

1. QuantStudio™ 7 Pro Real-Time PCR System

2. QuantStudio™ Design and Analysis Software v2

Note: The QuantStudio™ 7 Pro Real-Time PCR System profile must be installed before theQuantStudio™ Design and Analysis Software v2 profile.

Enable SAE on the instrument and specify the SAE server (administratoronly)

This procedure requires a local administrator profile on the instrument and an SAE administratoraccount in the SAE Administrator Console.

1. In the home screen, tap (Settings)4SAE.The SAE Mode screen is displayed.

2. In the SAE Mode screen, set the SAE Mode slider to Enable.

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3. Tap the Server IP field, then enter the IP address of the SAE server.

4. Tap the Port field, enter the port, then tap Next.

5. Enter the SAE administrator user name and password when prompted, then tap Enable.

The home screen is displayed. The SAE administrator is signed in.

Connect to the SAE server in QuantStudio™ Design and Analysis Software v2

• Install the SAE Administrator Console and the SAE server on a computer with a static IP address(recommended) or a dynamic IP address.

• Before you connect, close all plate files and data files.

Note: Connect the software and any instruments to the same SAE server to ensure that audit recordsare maintained across system components.

1. In the menu bar, click System4SAE Connection Settings.

2. Enter the IP address and port number of the SAE server.

Note: If using a dynamic IP address, enter the hostname instead of the IP address to prevent theloss of a connection.

3. (Optional) Click Test Connection to confirm that the connection information is correct.

4. Click Save.

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Enable SAE functions in QuantStudio™ Design and Analysis Software v2

This procedure requires an SAE administrator account.

Before you enable SAE functions in the QuantStudio™ Design and Analysis Software v2, you mustcomplete the following tasks:

• Connect to the SAE server (see “Connect to the SAE server in QuantStudio™ Design and AnalysisSoftware v2” on page 25).

• Close all plate files and data files.

1. In the QuantStudio™ Design and Analysis Software v2, select System4Enable Security.

2. Enter your SAE administrator account user name and password, then click Sign In.

The SAE administrator account is automatically signed into the software after SAE is enabled. The SAEuser name is displayed in the upper-right corner of the software menu bar.

Disable SAE on the instrument (administrator only)This procedure requires a local administrator profile and an SAE administrator account.

Sign in with a local administrator account (see “Sign in as a local administrator with SAE enabled” onpage 27).

1. In the home screen, tap (Settings)4SAE.The SAE Mode screen is displayed.

2. In the SAE Mode screen, set the SAE Mode slider to the Disable position, then tap Done.

3. Enter the password for the SAE administrator account, then tap Disable.

The user name for the SAE administrator account is filled out and cannot be edited.

The Sign In screen is displayed.

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Disable SAE functions in QuantStudio™ Design andAnalysis Software v2

This procedure requires an SAE administrator account.

Close all plate files and data files.

1. In QuantStudio™ Design and Analysis Software v2, select System4Disable Security.

2. Enter the password of the SAE administrator account, then click Sign In.

Sign in as a local administrator with SAE enabledSign in as a local administrator to access the instrument settings. Plate files are not accessible if youare signed in as a local administrator.

1. In the Sign In screen, tap Sign in under Local sign in.

1

1 Sign in for administrator

The Local Administrator Sign In screen is displayed.

2. In the Local Administrator Sign In screen, select your local administrator profile.

3. Enter your PIN, then tap Enter.

The Settings screen is displayed.

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Change your SAE account password on the instrumentThe QuantStudio™ Design and Analysis Software v2 and the instrument must be connected to thesame SAE server in order for the SAE account password to be updated for both the software and theinstrument.

You must be signed in with the instrument in SAE mode.

1. In the home screen, tap (Profile).The My Profile screen is displayed. The SAE button is selected, and the profile that is signed in islisted.

1

2

Figure 1 My Profile screen

1 SAE button is active

2 Profile that is signed in

2. Tap Edit.The Edit My Profile screen is displayed.

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Figure 2 Edit My Profile screen

3. Tap the Old password field, enter the current SAE account password, then tap Enter.

4. Tap the New password field, enter a new SAE account password, then tap Enter.

(Optional) Tap the Show password checkbox to show or hide the password.

5. Tap the Confirm password field, enter the new SAE account password again, then tap Enter.

6. Tap Done.

Your SAE password will also be changed on the QuantStudio™ Design and Analysis Software v2 if theinstrument and the software are connected to the same SAE server.

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SAE Administrator Console functions

Functions that are controlled

The following functions are controlled, depending on the user role:

• Plate setup, including the following functions:– Create a new template

– Edit the run method

– Edit the analysis settings

– Define, edit, or delete the targets or the assays

– Assign the target or the assay

– Define, edit, or delete the sample

– Assign the samples

– Define, edit, or delete the reagents

– Assign the reagents

• Add and delete a custom dye

• Start and stop an instrument run

• Calibration runs and RNase P verification runs

• Instrument configuration, including the following functions:– Software update

– Network configuration

– Instrument name change

– Date and time change

– SAE module setting modification

– Sleep setting modification

– Instrument access modification

– Disk management setting modification

– Instrument back-up and restore a back-up

• Log into timed out sessions

• Perform e-signatures

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Functions that can be audited

Certain instrument functions can be audited. This depends on how the SAE administrator hasconfigured the audit settings.

Note: Template and data files are checksum protected.

· Checksum protection ensures that files produced by the instruments are not edited outside of thesystem.

· Files produced by the software applications are checksum protected by the software, regardless ofwhether the SAE Administrator Console is enabled.

The following functions can be audited:

• Changes to a plate file, including the following items:– Plate layout

– Analysis settings

– Run method

– Samples

– Assays

• Sign in success and sign in failure

• Sign out

• Enable and disable the SAE Administrator Console

• Perform a calibration run

• Perform an RNase P verification run

• Start and stop an instrument run

• Pause and resume an instrument run

Functions that can be signed

Certain instrument functions can be signed. This depends on how the SAE administrator has configuredthe e-signature settings.

The following functions can be signed with an e-signature:

• Start an instrument run

• Plate setup

• Plate results

Default permissions and rolesThe SAE module provides the following default permissions and roles. You can use the default roleswhen you create SAE user accounts or create custom roles (see “Create a role” on page 50).

• Administrator

• Scientist

• Technician

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IMPORTANT! SAE permissions for a role apply to all user accounts that are assigned to the role.

The roles and associated user-configurable permissions are listed in the following table. You can alsodouble‑click the role in the Roles tab to display the list of permissions.

Note: The No Privileges role is used by the software when you set up user repositories. Do not assignthis role to a user account.

FunctionRole

Administrator Scientist Technician

Set up

Create a new plate file Yes Yes Yes

Edit the run method Yes Yes No

Edit the analysis settings Yes Yes Yes

Define, edit, or delete the targets or the assays Yes Yes Yes

Assign a target or an assay Yes Yes Yes

Define, edit, or delete a sample Yes Yes Yes

Assign a sample Yes Yes Yes

Define, edit, or delete a reagent Yes Yes Yes

Assign a reagent Yes Yes Yes

Dye

Add a new custom dye Yes Yes No

Delete a custom dye Yes Yes No

Instrument run

Start a run Yes Yes Yes

Stop a run Yes Yes Yes

Calibration

Perform a system dye calibration Yes Yes No

Perform an ROI and uniformity calibration Yes Yes No

Perform a background calibration Yes Yes No

Perform a custom dye calibration Yes Yes No

Perform a custom melt calibration Yes Yes No

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(continued)

FunctionRole

Administrator Scientist Technician

Instrument verification

Perform an RNase P verification Yes Yes No

Instrument configuration

Perform firmware update Yes No No

Configure the network Yes No No

Change the instrument name Yes No No

Modify the date and the time Yes No No

Modify the SAE settings Yes No No

Modify the sleep mode settings Yes No No

Modify the instrument access settings Yes No No

Modify the disk management settings Yes No No

Perform a backup and restore Yes No No

Security configuration

Log into timed-out user sessions Yes Yes No

Perform e-signing Yes Yes No

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Dialog boxes in the SAE moduleSome of the features and functions described might not be accessible to you. The features andfunctions that are available depend on the way that the SAE administrator has configured them.

Dialog box Description

An action is set up for auditing andrequires you to specify a reason for theaction.

An action is set up for electronic signatureand allows you to enter your password toallow the action.

If you do not have access to a function, you will not be able to select it.

For example, the buttons to start any of the calibrations are inactive if your role does not havepermission to perform a calibration.

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Sign a plate setup1. In the home screen, tap one of the following options:

• (Load plate file)

• Set up run

2. Tap the location of the system template or the plate file in the left column.

• Run Queue

• Public

My Instrument

• Network Drive

• USB Drive

3. Tap the template file name in the right column.The Plate Properties screen is displayed.

4. In the Plate Properties screen, tap Actions.The Actions screen is displayed.

5. Tap Sign plate.The Sign Plate screen is displayed.

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6. Select the purpose from the Purpose dropdown list.

7. Enter your SAE user name and password.

8. Tap Sign plate.

Enter an audit reasonDepending on the way that your SAE administrator configures audit settings, the Enter Audit Reasonscreen may be displayed when you make changes to one of the following items:

• Plate file

• Calibration

• RNase P run

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View signing records for a plate file1. In the home screen, tap one of the following options:

• (Load plate file)

• Set up run

2. Tap the location of the system template or the plate file in the left column.

• Run Queue

• Public

My Instrument

• Network Drive

• USB Drive

3. Tap the template file name in the right column.The Plate Properties screen is displayed.

4. In the Plate Properties screen, tap Actions.The Actions screen is displayed.

5. Tap View signing records.The Signing records screen is displayed.

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6. Tap a row to view the details.

7. Tap Close to return to the Signing records screen.

View audit recordsThe audit records cannot be viewed on the instrument touchscreen. The audit records are viewed onthe QuantStudio™ Design and Analysis Software v2 or on the SAE Administrator Console.

Use the instrument when the SAE server is offlineIf your SAE administrator has configured your instrument to allow use when the SAE server is offline(Client offline login System setting in the SAE module), you can use the instrument for the period oftime specified by the SAE administrator for Client offline login.

Note: If you have not previously signed into the instrument with your SAE account, you cannot sign inwhen the SAE server is offline.

All SAE records are retained if the instrument is disconnected from an SAE server. When the instrumentis reconnected to the SAE server, SAE records are uploaded to the server.

The following functions are not available when the SAE server is offline:

• Account lockout, password reminder, mandatory password change

• Disable SAE

• Change Password

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E-signature requirements to start a runDepending on the way your SAE administrator has configured your instrument, E-signatures may berequired when you start a run. If starting a run is configured to require signatures, a message isdisplayed when you start a run.

Tap Sign plate to sign the plate and start the run.

Signing in after automatic screen lockingDepending on the way your SAE administrator has configured your instrument, the instrumenttouchscreen may automatically lock after a specified duration.

An Administrator role or a Scientist role can sign in after automatic screen locking.

SAE error messages and actions

Message Possible cause Action

Unable to connect to SAE server.Check current connections.

The SAE server connection settingsare incorrect.

1. Check the SAE server IPaddress.

2. In the instrument Sign Inscreen, sign in with a localadministrator account.

3. Set the correct IP address(see “Enable SAE on theinstrument and specify the SAEserver (administrator only)” onpage 24).

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(continued)

Message Possible cause Action

Unable to connect to SAE server.Check current connections.

There is a problem with the computeron which the SAE AdministratorConsole is installed or a problem withthe network.

Troubleshoot computer or networkproblems.

The computer on which the SAEAdministrator Console has a dynamicIP address that is disconnectingthe server when the computer isrestarted.

Set a static IP address on thecomputer.

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Configure the SAE module forQuantStudio™ Absolute Q™ Digital

PCR Software

■ Overview of the QuantStudio™ Absolute Q™ Digital PCR Software functionality when SAEis enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

■ Enable SAE functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

■ Sign into QuantStudio™ Absolute Q™ Digital PCR Software using an SAE account . . . . . . . . . . . 43

■ Sign out of the software using an SAE account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

■ Change your SAE account password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

■ Default permissions and roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

■ Specify audit reason . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

■ View audit records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

■ Export audit records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

■ Sign data in the software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

■ View e-signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

■ Disable SAE functions in QuantStudio™ Absolute Q™ Digital PCR Software . . . . . . . . . . . . . . . . . 47

Overview of the QuantStudio™ Absolute Q™ Digital PCRSoftware functionality when SAE is enabled

The following features are active when SAE functions are enabled in the QuantStudio™ Absolute Q™

Digital PCR Software:

• Users must sign in with an SAE user account to use QuantStudio™ Absolute Q™ Digital PCRSoftware.

• Auditing functions are active (if they are enabled in the SAE Administrator Console).

• Run setup and software functions for a user are determined by the SAE application profile and useraccount settings.

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SAE functions not supported by the QuantStudio™ Absolute Q™ Digital PCRSoftware

The following SAE functions are not supported by the QuantStudio™ Absolute Q™ Digital PCR Software.

Function Option not supported

System > Other Settings • Open file from non-SAE system

• Client offline sign in

• Offline sign in threshold

Audit history Instrument Run Records

LDAP connectivity —

Enable SAE functions

Workflow

Enable SAE functions

Configure SAE Administrator Console application profiles (page 42)

Connect to the SAE server (page 43)

Enable SAE functions in QuantStudio™ Absolute Q™ Digital PCRSoftware (page 43)

Configure SAE Administrator Console application profiles

Note: Configuring application profiles in the SAE Administrator Console requires an SAE administratoraccount.

In the SAE Administrator Console, an application profile contains default settings for an application.Before using SAE an administrator must install, then configure the profile for the QuantStudio™ AbsoluteQ™ Digital PCR Software.

For information on configuring application profiles, see “Set up the SAE Administrator Console withapplication profiles” on page 13.

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Connect to the SAE server

• Install the SAE Administrator Console on the dedicated computer with a static IP address(recommended) or a dynamic IP address.

• Install, then configure profiles for the QuantStudio™ Absolute Q™ Digital PCR Software.

For information on configuring application profiles, see “Set up the SAE Administrator Console withapplication profiles” on page 13.

1. In the menu bar, click System4SAE Connection Settings.

2. Enter the IP address and port number of the SAE server.

Note: If using a dynamic IP address, enter the hostname instead of the IP address to prevent theloss of a connection.

3. (Optional) Click Test Connection to confirm that the connection information is correct.

4. Click Save.

Enable SAE functions in QuantStudio™ Absolute Q™ Digital PCR Software

This procedure requires an SAE administrator account.

Before you enable SAE functions in the QuantStudio™ Absolute Q™ Digital PCR Software, you mustcomplete the following tasks:

• Connect to the SAE server (see “Connect to the SAE server” on page 43).

• Close all protocol or analyzed run files.

1. In the QuantStudio™ Absolute Q™ Digital PCR Software, select System4Enable Security.

2. Enter your SAE administrator account user name and password, then click Sign In.

The SAE administrator account is automatically signed into the software after SAE is enabled. The SAEuser name is displayed in the upper-right corner of the software menu bar. All users must sign into thesoftware while SAE is enabled.

Sign into QuantStudio™ Absolute Q™ Digital PCR Softwareusing an SAE account

Sign in for the QuantStudio™ Absolute Q™ Digital PCR Software is only required if SAE functions areenabled by an SAE administrator (see “Enable SAE functions in QuantStudio™ Absolute Q™ Digital PCRSoftware” on page 43).

1. In the QuantStudio™ Absolute Q™ Digital PCR Software sign in screen, enter your SAE user nameand password.

2. Click Sign In.

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The user name of the SAE account that is signed in to the software appears in the menu bar.

Sign out of the software using an SAE account1. In the lower-left corner of the left pane, click .

2. Click Sign Out.

Change your SAE account password

Note: External user accounts (External/Federated LDAP repository accounts) cannot change theirpassword in the software.

1. In the lower-left corner of the left pane, click .

2. Click Change Password.

3. Enter the password information, then click OK.

Default permissions and rolesThe SAE module provides the following default permissions and roles. You can use the default roleswhen you create SAE user accounts or create custom roles in the administrator console (see “Create arole” on page 50).

• Administrator

• Scientist

• Technician

• Service

IMPORTANT! SAE permissions for a role apply to all user accounts that are assigned to the role.

The roles and associated user-configurable permissions are listed in the following table. You can alsodouble‑click the role in the Roles tab to display the list of permissions.

Note: The No Privileges role is used by the software when you set up user repositories. Do not assignthis role to a user account.

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Function DescriptionRole

Administrator Scientist Technician Service

Miscellaneous

Service access Access to theinstrument servicemenu.

No No No Yes

Application administration Access toapplicationadministrationmenus.

Yes No No Yes

Generate report Create analysisreports.

Yes Yes Yes Yes

Instrument Control

Edit protocol Edit run protocols. Yes Yes No Yes

Start run Choose a protocoland start and stopinstrument runs.

Yes Yes Yes Yes

Run analysis

Change thresholds Change channelthresholds.

Yes Yes No Yes

Edit groups Edit groupdefinitions.

Yes Yes No Yes

Rename samples Change samplenames.

Yes Yes Yes Yes

Assign samples Assign samples toset groups or loada group set.

Yes Yes Yes Yes

Hide samples Show or hidesamples from ananalysis.

Yes Yes No Yes

Run management

Delete run Delete a run fromthe database.

Yes No No Yes

e-sign run Place an electronicsignature on a run.

Yes Yes No Yes

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(continued)

Function DescriptionRole

Administrator Scientist Technician Service

Import run Import and exportruns to and fromZST files.

Yes Yes No Yes

Edit run Edit run features. Yes Yes No Yes

Specify audit reasonDepending on how your SAE administrator configures the audit settings in the SAE AdministratorConsole, the Enter Audit Reason screen may be displayed when you make changes to a protocol oran analyzed run in the QuantStudio™ Absolute Q™ Digital PCR Software.

Select a reason from the drop down list, or add a custom reason.

Note: Custom Reason is not displayed if audit settings are configured to require users to select areason.

View audit recordsFor information on viewing audit records for a protocol or an analyzed run, see Chapter 7, “Manage theaudit function”.

Use the following steps to view the audit record of a specific run by using the Run ID for the run.

1. In the QuantStudio™ Absolute Q™ Digital PCR Software, select the desired run.

For information on selecting a run, see the QuantStudio™ Absolute Q™ Digital PCR SystemInstallation, Use, and Maintenance Guide.

2. In the upper-right corner of the Run screen, hover over the Run ID and click Copy to clipboard.

3. At the SAE Administrator Console perform the following steps:

a. Select Audit History > Application Object Records.

b. Select Enable Application Objects Filtering.

c. In the Object name field, paste the Run ID that you copied in step 2.

d. Click Search.

The information regarding the run appears in results area of the Audit History screen.

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Export audit recordsFor information on exporting audit records for a protocol or an analyzed run, see Chapter 7, “Managethe audit function”.

Sign data in the software1. In the left pane, click to access the Runs page.

2. Use the search fields to find a run or select a run from the list, then select the RESULTS tab.

3. In the upper-right side of the page click .

4. Select an option from the drop down list to indicate the meaning of the e-signature.

• Reviewed and Approved Plate Results

Note: The number of options will vary based on your configuration.

5. Enter your user name and password.

6. Click Sign.

If a run is signed and unmodified, the signature will show on reports that are created using GENERATEREPORT.

For information on viewing e-signatures in the SAE software, see Chapter 8, “Manage the e-signaturefunction”.

View e-signaturesFor information on viewing e-signatures, see Chapter 8, “Manage the e-signature function”.

Disable SAE functions in QuantStudio™ Absolute Q™ DigitalPCR Software

This procedure requires an SAE administrator account.

Close all plate files and data files.

1. In QuantStudio™ Absolute Q™ Digital PCR Software, select System4Disable Security.

2. Enter the password of the SAE administrator account, then click Sign In.

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Manage SAE user accounts androles

■ Create an SAE user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

■ Edit an SAE user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

■ Activate a suspended SAE user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

■ Disable (inactivate) an SAE user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

■ Reset an SAE user account password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

■ Manage roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

■ View or print a user or role report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Create an SAE user account1. In the SAE Administrator Console main screen, click the Users tab.

2. Click Create, then enter the user name, password, first name, (optional) middle initial, and lastname. The field limits are specified in the system security function settings.

Note:

· First name, MI (middle initial), and last name are used to create the User Full Name, which isdisplayed as the name of the signed-in user.

· You cannot change the user name after you save the user account.

3. Select User must set new password at next sign in to require the user to specify a newpassword the first time they sign in to an application.

Note: The user account password automatically expires after the number of days that arespecified in the system security function settings.

4. Select the Role for the user account.

Note:

· Each role grants specific SAE permissions to the user.

· The No Privileges Role is for internal use by the SAE Administrator Console. Do not assign thisrole to a user account.

5. Leave the status set to ACTIVE.

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

7. Click Save.

Edit an SAE user account1. In the SAE Administrator Console main screen, click the Users tab.

2. Select a user account, then click Edit.

3. Edit the settings as desired.

Note: You cannot edit the user name of an existing user.

4. Click Save.

Activate a suspended SAE user account1. In the SAE Administrator Console main screen, click the Users tab.

2. Select a user account, then click Edit.

3. Change the Status from SUSPENDED to ACTIVE.

4. Click Save.

Disable (inactivate) an SAE user account1. In the SAE Administrator Console main screen, click the Users tab.

2. Select a user account, then click Edit.

3. Change the Status from ACTIVE to INACTIVE.

4. Click Save.

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Reset an SAE user account password

IMPORTANT! There is no way to recover a forgotten password. If the SAE Administrator forgets theirpassword, the software must be reinstalled. Export all data before reinstalling the software. Otherwise,the data will be lost. For more information, see Chapter 9, “Advanced configuration options”.

1. In the SAE Administrator Console main screen, click the Users tab.

2. Select the affected user account, then click Edit.

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

4. If you assigned the user account a temporary password, then select User must set newpassword at next sign in to require the user to enter a new password at sign in.

5. Click Save.

Manage rolesSAE roles determine the SAE permissions that are associated with an SAE user account.

If your SAE Administrator Console is configured to manage the SAE module for more than oneapplication, you can create roles that specify permissions for more than one application.

For a list of permissions for a specific application, see the chapter for the application.

IMPORTANT! SAE permissions for a role apply to all user accounts that are assigned to the role.

Create a role

1. In the SAE Administrator Console main screen, click the Roles tab.

2. Click Create.

3. Enter a role name and (optional) description.

4. Select one or more applications to which the role applies.

5. Select SAE permissions for the role. To select all SAE permissions in a category, select thecheckbox next to the category.

6. Click Save.

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Edit a role

1. In the SAE Administrator Console main screen, click the Roles tab.

2. Select a role, then click Edit.

Note: You cannot edit the Administrator role.

3. Edit settings as needed, then click Save.

Delete a role

Note: If any SAE user account is assigned to a role, that role cannot be deleted.

1. In the SAE Administrator Console main screen, click the Roles tab.

2. Select a role, then click Delete.

View or print a user or role report1. In the SAE Administrator Console main screen, click the Users or Roles tab.

2. Click Report.The user report or role report downloads to the default location set in the web browser.

3. Access the report, save, then print the report.

4. Close the report.

Chapter 5 Manage SAE user accounts and rolesView or print a user or role report 5

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Manage the system securityfunction

Enable or disable the system security functionThe system security function cannot be disabled in the SAE Administrator Console. To disable user signin to an application, you must disable SAE in the application.

For instructions on how to enable or disable the SAE in an application, see the chapter for theapplication.

Configure account setup and security policiesSettings in this screen affect all SAE user accounts. Settings are applied the next time that users sign into an application.

1. In the SAE Administrator Console main screen, click the System tab.

2. In the User Name Settings pane, specify the user name requirements and limits (user namelength, and so on).

3. In the Password Policy pane, specify the password requirements and limits (password requiredcharacters, and so on).

4. (Optional) In the Account Lockout Policy pane, enable or disable the Account lockout feature. Ifyou enable this feature, specify the following settings:

Settings Description

Threshold and Accountlockout duration

If a user attempts to sign in with an incorrect user name or passwordmore than the number of times set for the threshold, the user is locked outfor the time specified.

Sign in attempts counterreset andReset failure sign incounter after

If the counter reset is enabled, the counter resets to 0 after the timespecified.For example, if a user is locked out because of exceeding the number offailed sign-in attempts, the user will be able to attempt to sign in after thetime specified.

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5. (Optional) In the Other Settings pane, specify the following settings:

Settings Description when enabled

Automatic screen locking andInactivity duration

The screen is locked if there is no activity for the time specified. Auser must enter their user name and password to unlock the screen.

Open file from non‑SAEsystem

The application allows users to access data files that weregenerated when SAE functions were disabled.

Client offline sign in[1] andOffline sign in threshold

When the SAE server is offline, users can sign in and use anapplication for the time specified.

[1] If this setting is not displayed under Other Settings, this function is not available for your application.

6. Click Apply Settings.

Note: Click Reset to Defaults to reset all the system security settings to their default values.

Chapter 6 Manage the system security functionConfigure account setup and security policies 6

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Manage the audit function

■ Enable or disable the audit function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

■ Select items to audit and set the Audit Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

■ Configure audit reason settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

■ View audit logs (audit history) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

■ Archive and restore audit records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Enable or disable the audit functionUse the Audit tab to control:

• Events that are audited

• List of reasons that are available to users when the audit mode is set to Optional or Required (see“Select items to audit and set the Audit Mode” on page 54)

Note: When the Audit mode is set to Silent, audit reasons are not available for user selection in anapplication.

1. In the SAE Administrator Console main screen, click the Audit tab.

2. Select or deselect Enable Audits.

3. (Optional) Set or modify the Audit Settings and the Audit Reason Settings.

4. Click Apply Settings.

Select items to audit and set the Audit Mode1. In the SAE Administrator Console main screen, click the Audit tab.

2. In the Audit Settings pane, select the items to audit.

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3. Select the Audit Mode for each item you include for auditing:

Option Description

Silent The event is audited, no reason prompt is displayed.

Optional The event is audited, a reason prompt is displayed, but the user can cancel and continuewithout entering a reason.

Required The event is audited, a reason prompt is displayed, and the user must specify a reason.

4. Click Apply Settings.

Configure audit reason settingsConfigure audit reason settings in the Audit tab.

• (Optional) Select Require users to select a reason for change from list to require users to selecta pre-defined audit reason from the Reason list.

• Add new audit reason:

a. Click New Reason.

b. Enter a reason for change, then click Save.

c. Click Apply Settings.

• Edit an existing audit reason:

a. Click Edit.

b. Edit the reason for change, then click Save.

c. Click Apply Settings.

• Delete an existing audit reason:

a. Click Delete.

b. Click Delete to confirm deletion of the audit reason or Cancel to exit the dialog box.

c. Click Apply Settings.

Note: After deleting an audit reason, its ID number is also deleted and the ID number is not reusedfor the next audit reason in the list.

Chapter 7 Manage the audit functionConfigure audit reason settings 7

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View audit logs (audit history)

View the System Configuration audit log

1. In the SAE Administrator Console main screen, click the Audit History tab.

2. Select System Configuration to view a log of the system security, audit, and e-signatureconfiguration records.

3. To display a list of items that are audited:

a. Select Enable System Configuration Records Filtering.

b. In the Record type field, click .The list of auditable system configuration objects is displayed.

View the Action Records audit log

All items in the action records log are audited silently.

1. In the SAE Administrator Console main screen, click the Audit History tab.

2. Select Action Records to view a log of the specified audit events.

3. To display a list of items that are audited for your application:

a. Select Enable Action Records Filtering.

b. Select your application from the Application list.

c. In the Action field, click .The list of auditable actions is displayed.

4. (Optional) Perform the following actions:

• Specify other filtering settings.

• Click Report to generate a PDF file of the log.

• Click Export to generate a TXT file of the log.

Auditable actions in the SAE Administrator Console

• Enable or disable security, audit, or e‑signature

• Sign in to or out of the SAE Administrator Console

• Import or export an SAE configuration

• Install an application profile

• Archive, purge, or restore audit records

• Manual Sync with LDAP Directory

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View Application Object Records audit log

Application objects are auditable items such as plate setups, templates, or other items that you createin an application.

1. In the SAE Administrator Console main screen, click the Audit History tab.

2. Select Application Object Records.

3. To display a list of items that are audited for your application:

a. Select Enable Application Object Records Filtering.

b. Select your application from the Application list.

c. In the Having data audit record type field, click .The list of auditable objects is displayed.

4. (Optional) Perform the following actions:

• Specify other filtering settings.

• Click Report to generate a PDF file of the log.

Note: Export is not supported for this audit log.

View Instrument Run Records audit log

Audit records are listed when a run is complete.

1. In the SAE Administrator Console main screen, click the Settings tab.

2. Select Instrument Run Records.

See the following table for a description of the records that are displayed.

3. (Optional) Perform the following actions:

• Select Enable Instrument Run Records Filtering to limit the records that are displayed.

• Click Report to generate a PDF file of the log.

Note: Export is not supported for this audit log.

Tab Displays

Run Summary • The user who started the run

• The instrument on which the run was started (Host ID and Instrument name)

• The setup file used for the run and the run name

• Run date and duration

Application objects Information about the objects used in a run (for example, a plate or a template)

Action records Actions performed during a run (for example, start or cancel a run)

Chapter 7 Manage the audit functionView audit logs (audit history) 7

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(continued)

Tab Displays

Data audit records Information about changes made during a run

Run completion outputs List of objects generated by the run (for example, data files)

Archive and restore audit records

Archive audit records

Archiving audit records removes the records from the SAE Administrator Console and saves them in aninternally specified location on the same computer on which the SAE Administrator Console is installed.

Note: Archived audit records are accessible for viewing in the SAE Administrator Console.

• To archive audit records automatically:

a. In the SAE Administrator Console main screen, click the Settings tab.

b. Select Auto Archive.

c. Select Enable Auto Archive, then select the Archival mode and associated settings:

– By number of records or retention period

– By number of records

– By retention period

d. Click Save.The software periodically checks the audit record status and archives when the specifiedarchive conditions are met.

• To archive audit records manually:

a. In the SAE Administrator Console main screen, click the Settings tab.

b. Select Archival history.

c. Click Ad-hoc Archive, select the start and end dates, then click Archive.

View or export archived audit records

1. In the SAE Administrator Console main screen, click the Settings tab.

2. Select Archival history.

3. Select a record, then click View Archived Records or Export.

Chapter 7 Manage the audit functionArchive and restore audit records7

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Restore archived audit records

1. In the SAE Administrator Console main screen, click the Settings tab.

2. Select Archival history.

3. Select a restore option:

• Restore—Restores an archived record. Click a record, then click Restore.

• Restore (upload)—Restores a ZIP file that was exported from the archival history. ClickRestore (upload), then select the ZIP file.

Chapter 7 Manage the audit functionArchive and restore audit records 7

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Manage the e-signature function

■ Enable or disable the e‑signature function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

■ Select the actions that require e-signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

■ Configure the meanings of e-signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Enable or disable the e‑signature functionUse the e‑signature tab to control the e‑signature rights of SAE roles, the reasons available fore‑signature, and the data to be signed.

1. In the SAE Administrator Console main screen, click the E‑signature tab.

2. Select or deselect Enable e‑signature.

3. (Optional) Set or modify the e‑signature settings.

4. Click Apply Settings.

Select the actions that require e-signature1. In the SAE Administrator Console main screen, click the E‑signature tab.

2. In the Actions Requiring Signatures pane, select each action that requires an e‑signature.

3. For each meaning of each selected action, enter the number of e‑signatures that are required fromeach SAE role before the associated action can be performed.

4. Click Apply Settings.

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Configure the meanings of e-signaturesThe e‑signature meanings are the text that a user can select to describe a reason for an e‑signature.

Add an e‑signature meaning

1. In the SAE Administrator Console main screen, click the E‑signature tab.

2. In the e‑signature Meanings pane, click New meaning.

3. Enter an e‑signature meaning in the Name field, then click Save.

4. Select a meaning. Then, in the Data signed for the selected meaning list, select the item withwhich to associate the meaning.

5. Set the actions that require e‑signature and the number of e‑signatures that are required for thataction.

6. Click Apply Settings.

Delete an e‑signature meaning

1. In the SAE Administrator Console main screen, click the E‑signature tab.

2. In the e‑signature Meanings pane, select a meaning from the Meanings list, then click Delete.

3. Confirm the deletion of the meaning, then click OK.

4. Click Apply Settings.

Chapter 8 Manage the e-signature functionConfigure the meanings of e-signatures 8

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Advanced configuration options

■ Export and import user, system security, audit, and e‑signature settings . . . . . . . . . . . . . . . . . . . . . 62

■ Configure user repositories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Export and import user, system security, audit, ande‑signature settings

Use the export and import functions to transfer settings from one installation of the SAE AdministratorConsole to another.

• To export settings:

a. In the SAE Administrator Console main screen, click the Settings tab.

b. Select Export Configuration.

c. In the Export Configuration dialog box, select an export option:

Setting Exports

All SAE settings and SAE user accounts

Custom Users & Roles – SAE user accounts with Active status

– SAE roles and their associated permissions

Custom System & Roles – SAE settings

– SAE roles and their associated permissions

d. Click Export.The exported file (DAT format) downloads to the default location of the computer.

• To import settings on another installation of the SAE Administrator Console:

a. In the SAE Administrator Console main screen, click the Settings tab.

b. Select Import Configuration.

c. Click Choose File to select the DAT file with the desired configuration settings.

d. Select an import option.

e. Click Import.

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f. If imported user accounts exist in the SAE Administrator Console, click Skip or Overwrite foreach user account, then click Confirm and Import.

Configure user repositories

User repository overview

SAE user account information is stored in a "user repository".

The SAE Administrator Console provides the following options for user repositories:

• Internal—Allows only SAE user accounts to sign in to an application. SAE user accounts arereferred to as "local" accounts in the SAE Administrator Console.

– SAE user accounts are created in the SAE Administrator Console and are identified as "local"in the Users tab.

– User authentication is based on the accounts that are listed in the Users tab and the SAEsettings that are specified in the System tab.

– User permissions are determined by the roles that are configured in the SAE AdministratorConsole.

• External LDAP—Enables LDAP based authentication with an LDAP directory. Allows only externaluser accounts to sign in to an application.

– User accounts are created in an LDAP (Lightweight Directory Access Protocol) usermanagement system and are identified as "external" in the SAE Administrator Console Userstab.

– User authentication is based on the accounts that are listed in the SAE Administrator ConsoleUsers tab and the external LDAP user repository.The following settings from the System tab are not used for LDAP:

– User Name Settings pane, Password Policy pane, and the Account Lockout Policypane.

The settings that are specified in the Other Settings pane are used.

– User permissions are determined by the roles that are configured in the SAE AdministratorConsole.

– All local user accounts except the default Administrator account are set to Inactive.

– Passwords cannot be changed in the SAE Administrator Console.

• Federated—Allows internal (local) and external account sign-in to an application.– User accounts are created in the SAE Administrator Console or in an LDAP user management

system.

– User authentication is based on the respective internal or LDAP user repository.

Chapter 9 Advanced configuration optionsConfigure user repositories 9

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Configure user repositories for SAE or external account access

IMPORTANT! Use this function only with guidance from a service or applications representative.

1. In the SAE Administrator Console main screen, click the Settings tab.

2. Select User repositories (advanced).

3. Select the User repository definition:

Option Description

Internal UserRepository

Allows SAE user accounts to sign in

External LDAP UserRepository

Allows external user accounts to sign in

FederatedRepositories

Allows SAE user accounts or LDAP accounts to sign in

4. If you selected External LDAP User Repository or Federated Repositories, click Next, thenenter the required information (see “User repository settings” on page 64).

5. Click the Users tab to display the list of accounts added to the SAE Administrator Console.

• New LDAP accounts are listed as External, and Role is set to the default specified duringaccount mapping. If no default was specified, accounts are set to No Privileges Role.

• SAE user accounts that were previously created in the SAE Administrator Console are listed asLocal.

• If you selected LDAP, the Status for all accounts except for the default SAE Administratoraccount is set to Inactive.

6. Click Test Connection to synchronize the new accounts with the LDAP server.

The SAE server also periodically syncs the LDAP accounts with the LDAP server if changes aremade to the User repository definition or any setting on the LDAP server.

7. If needed, edit the user accounts to assign roles.

User repository settings

Table 1 External LDAP User Repository and Federated Repositories settings

Setting Description

LDAP Server Configuration

Host name, Port, and Usessl

LDAP server name or IP address, port, and interface protocol

Bind distinguished name,Bind password, Basedistinguished name

LDAP server attributes required for access

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Table 1 External LDAP User Repository and Federated Repositories settings (continued)

Setting Description

User Account Mapping

Directory type LDAP server configuration

Click Set Defaults after you select the Directory type to display typical defaultparameters for mapping to an LDAP system.

User name Parameter that maps to the user name in the LDAP system

Default role assignment The SAE role that will be assigned to all user accounts. You can change the role afterthe user accounts are imported into the SAE Administrator Console.

User name and othersettings

Parameters that correspond to the user name and other fields in the LDAP system

Authentication verification

User Name and Password LDAP user name and password

User or administrator sign-in with LDAP or federated user repositories

Userrepository User signs in with Administrator signs in with

Internal Internal (local) account: User nameand password created in the SAEAdministrator Console

• User name and password for the default SAEAdministrator user account

• Any SAE user account that has been assigned theSAE role of Administrator

External External account: User name andpassword created in the LDAP usermanagement system.

Note: Local accounts are set to Inactive.

• User name (with local/ prefix) and password for thedefault SAE Administrator user accountExample: local/Administrator

• Any external account that has been assigned theSAE role of Administrator

Federated The account type that they are assigned:

• External account

• Internal (local) account (with local/prefix)Example: local/User name

• User name (with local/ prefix) and password for thedefault SAE Administrator user accountExample: local/Administrator

• Any external account that has been assigned theSAE role of Administrator

Chapter 9 Advanced configuration optionsConfigure user repositories 9

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Index

Aaction records log, view 56archive audit records 58audit

enable, disable 54manage 54

audit historyaction records 56system configuration 56

audit reason, specify 36audit record, restore 59audit records, archive 58audit settings

configure reasons 55default reasons 20export 62select items to audit 54tab 54

audited objects and actions 19

CChange password

SAE, Change password 28connect SAE server 25, 43

DDisable SAE 26

Ee-signature

enable, disable 60manage 60

e-signature settingsadd meaning 61delete meaning 61export 62select actions 60tab 60

FFunctions, SAE 30, 31

IInstrument features, SAE enabled 23

Nnetwork configuration and security 7

Ppassword security 7password, SAE

change 15reset 50

permissionsrole 31, 44SAE 50

Profiles, SAE 23

Rrestore audit records 59role

create 50default 31, 44delete 51edit 51permissions 31, 44

role report, generate, view, print 51roles, default 50

SSAE

change password 44dialog boxes 34disable 26, 27, 47disable on instrument 17enable 26, 43Enable, Workflow 24, 42enable on instrument 16, 24

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Functions 30, 31instrument features 23Profiles 23server, specify 16, 24Workflow, Enable SAE 24, 42

SAE admin console, start 12SAE email, configure SMTP server 14SAE messaging notifications, set up 14SAE role

create 50delete 51edit 51

SAE roles, default 50SAE server, connect 25, 43SAE user, determine 14security policies, configure 52SMTP server, configure 14Software sign in, SAE 43Software sign out, SAE 44suspended user account, activate 49system components, SAE enabled 22system configuration, view 56system security, manage 52system security settings

configure policies 52export 62

Tterms of use 10

Uuser account

disable, inactive 49edit 49reset password 50set up and configure 52

user account (SAE), create 48user report, generate, view, print 51user repository 63user role

default 17permissions 17

VView audit records (SAE) 38

Index

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