*716006210*

*Ver.01*

Empower 3 Service Release 4

Release Notes

716006210 Copyright © Waters Corporation 2020 Version 01 (previously released as Rev.A) All rights reserved General information

Copyright notice

© 2020 WATERS CORPORATION. PRINTED IN THE UNITED STATES OF AMERICA AND IN IRELAND. ALL RIGHTS RESERVED. THIS DOCUMENT OR PARTS THEREOF MAY NOT BE REPRODUCED IN ANY FORM WITHOUT THE WRITTEN PERMISSION OF THE PUBLISHER. The information in this document is subject to change without notice and should not be construed as a commitment by Waters Corporation. Waters Corporation assumes no responsibility for any errors that may appear in this document. This document is believed to be complete and accurate at the time of publication. In no event shall Waters Corporation be liable for incidental or consequential damages in connection with, or arising from, its use. For the most recent revision of this document, consult the Waters website (www.waters.com).

Trademarks

CitrixTM is a registered trademark of Citrix Systems, Inc. and/or one or more of its subsidiaries, and may be registered in the United States Patent and Trademark Office and in other countries.

EmpowerTM is a trademark of Waters Corporation.

LAC/ETM is a trademark of Waters Corporation.

Linux® is a registered trademark of Linus Torvalds.

Oracle® is a registered trademark of Oracle Corporation and/or its affiliates.

Red Hat® is a registered trademark of , Inc.

THE SCIENCE OF WHAT'S POSSIBLETM is a trademark of Waters Corporation.

WatersTM is a trademark of Waters Corporation.

Windows® is a registered trademark of Microsoft Corporation in the US and/or other countries.

XenApp® is a trademark of Citrix Systems, Inc. and/or one or more of its subsidiaries, and may be registered in the United States Patent and Trademark Office and in other countries. All other trademarks are property of their respective owners.

April 20, 2020, 716006210 Ver. 01 (previously released as Rev.A) Page ii Table of contents

General information ...... ii

Copyright notice ...... ii

Trademarks...... ii

Empower 3 Service Release 4...... 5

Updated sections in this document ...... 5

GxP compliance requirements...... 5

Anti-virus considerations...... 5 Empower installations...... 6

System and software requirements ...... 6 Driver compatibility ...... 7 NuGenesis SDMS and NuGenesis LMS compatibility ...... 8 Waters Data Converter compatibility ...... 11

Deployment notes ...... 12 Before you install the application...... 12 Creating an external tables directory for Message Center nearline tables in custom-built databases...... 12 Install Empower 3 Service Release 4...... 13 Performing a silent installation...... 14 Performing a push installation ...... 16 Push Installation of Empower 3 SR4 on multiple Empower Citrix servers ...... 17 Verify the Empower 3 SR4 installation ...... 19 Pharmacopeia versions...... 19 Database Management ...... 20

New features and enhancements ...... 20 Opening projects from Configuration Manager...... 20 Report Publisher enhancements ...... 20 Project directory names exclude special characters ...... 21 Sign Off remains selected after adjusting chromatogram scaling ...... 21

Issues resolved in this release...... 21 INFEMP-131 (PCS 48804)...... 21 INFEMP-132 (PCS 55890 and CRI-924)...... 21 INFEMP-134 (PCS 49036)...... 22

April 20, 2020, 716006210 Ver. 01 (previously released as Rev.A) Page iii INFEMP-3852 (PCS 48561)...... 22 INFEMP-3853 (PCS 56113) ...... 22 INFEMP-3854 (PCS 56525)...... 22 INFEMP-3862 and INFEMP-5140 (PCS 56378 and PCS 54545)...... 22 INFEMP-4530 (CRI 651) ...... 23 INFEMP-4587 and INFEMP-4742 (PCS 54287 and CRI-351)...... 23 INFEMP-4658 (PCS 56591)...... 23 INFEMP-4907 (PCS 55994 and CRI-350)...... 23 INFEMP-5025...... 24 INFEMP-5068 (CRI 734) ...... 24 PCS 55040 and CRI-432...... 24

Known issues in this release...... 24 INFEMP-3976...... 25 INFEMP-5233...... 25 INFEMP-5234...... 25 INFEMP-5265...... 25 INFEMP-5269...... 26 INFEMP-5456...... 26 INFEMP-5708...... 26

Program files modified in this release ...... 26 Program Files ...... 26 English language directory ...... 30 Japanese language directory ...... 32 Korean language directory ...... 35 Chinese language directory...... 37

Test configurations...... 40 Windows database server ...... 40 Red Hat database server...... 40 Empower File Server...... 57 Citrix Server (XenApp Server 7.15 Enterprise)...... 58 Client ...... 58 Standalone/Personal Workstation ...... 58 LAC/E module ...... 59

April 20, 2020, 716006210 Ver. 01 (previously released as Rev.A) Page iv Empower 3 Service Release 4

Updated sections in this document

The following sections in this document were updated from the previous version:

• System and software requirements • Driver compatibility • Before you install the application • Creating an external tables directory for message center nearline tables in custom-built databases • Install Empower 3 Service Release 4 • Performing a silent installation • Performing a push installation • Push installation of Empower 3 SR4 on multiple Empower Citrix servers • Database Management • INFEMP-4907 (PCS 55994 and CRI-350) • INFEMP-5025 • PCS 55040 and CRI-432

GxP compliance requirements

When you install Empower Software for the first time, or when you uninstall the software, perform software qualification to meet GxP compliance requirements. Any time you install or uninstall software in a GxP environment, Waters recommends that you follow your company’s management-approved standard operating procedures for changing software. To confirm that the application update did not affect any data, reprocess a data set before and after you install the software, and then verify that the results are equivalent. Run the Verify Files utility or the SystemsQT for Empower IQ, and review the resulting file for an entry that states “No installation changes were detected.”

Anti-virus considerations

Some real-time virus scanners mistake normal data acquisition and instrument control for virus activity, and thus interfere with proper operations. Full-system scans and live updates can be

April 20, 2020, 716006210 Ver. 01 (previously released as Rev.A) Page 5 network-intensive, disk-intensive, and CPU-intensive, and they can also interfere with normal data acquisition. Schedule scans and updates for idle times when data acquisition does not occur. Certain anti-virus program features like "intrusion prevention" and "tamper protection" can also interfere with normal operation. Disable them as well.

Empower installations

For Empower software installations, exclude the Empower installation folder (usually :\Empower) and its sub-folders.

System and software requirements

Empower 3 Service Release 4 software supports Windows 7 Service Pack 1 (SP1) on LAC/E modules only, Windows 10 Pro and Enterprise (Personal, Acquisition Client, and LAC/E modules), and Windows Server 2016 (Standard). Note: Support includes English, Japanese, Simplified Chinese, and Korean distributions of Empower 3 software. Specifically, Empower 3 Service Release 4 supports these platforms and operating systems:

Platform Operating systems and components

Personal workstation • Windows 10 Professional or Enterprise, 64- bit

• Oracle 18c a Empower client • Windows 10 Professional or Enterprise, 64- bit

• Oracle 18ca Citrix environment • Windows Server 2016 Standard (on the Virtual Delivery Agent (VDA) server) • Citrix Virtual Delivery Agent (VDA) 7.15 • Citrix XenApp 7.15 LTSR CU2 • Citrix Receiver 4.9 Database server • Windows Server 2016 Standard • Server 7.6

• Oracle 18ca File server • Windows Server 2016 Standard

April 20, 2020, 716006210 Ver. 01 (previously released as Rev.A) Page 6 Platform Operating systems and components

LAC/E module • Windows 7 Professional or Enterprise with SP1, 64-bit • Windows 10 Professional or Enterprise, 64- bit

• Oracle 18ca Notes: • LAC/E Acquisition Server Configuration 15 is supported with Windows 7 Professional (64-bit, for Windows Embedded Enterprise) SP1 and Windows 10 Enterprise 2016 LTSB (Long Term Service Branch) 64-bit. • LAC/E Acquisition Server Configuration 16 is supported with Windows 7 Professional (64-bit, for Windows Embedded Enterprise) SP1 and Windows 10 Enterprise 2016 LTSB (Long Term Service Branch) 64-bit. Virtualization technology Empower 3 Service Release 4 was tested using VMware vSphere ESXi 6.7 EP 04.

a. Embedded Oracle versions are 18.4.0.0.0. for the Oracle database and 18.3.0.0.0 for the Oracle client. The Oracle version required for RedHat is 18.4.0.0.0. The Oracle database is installed on server and Empower Personal installations. Oracle clients are installed on Empower Personal, Empower client, and LAC/E installations. Important: As of Empower 3 Feature Release 5, Windows Server 2008 and 2012 are no longer supported. See also: The Empower 3 Feature Release 5 Installation, Configuration, and Upgrade Guide (715006184) and the Empower 3 Feature Release 5 Release Notes (716006111) .

Driver compatibility

Empower 3 Service Release 4 supports Driver Pack 2019 Release 1 on Windows 10. See also: For information on the Waters driver, refer to the following document: • Waters Driver Pack 2019 Release 1 Installation and Configuration Guide (715006151) Recommendation: For Empower 3 Service Release 4, Waters recommends using only instrument drivers that are compatible with Windows 10.

April 20, 2020, 716006210 Ver. 01 (previously released as Rev.A) Page 7 NuGenesis SDMS and NuGenesis LMS compatibility

Empower 3 Service Release 4 is compatible with NuGenesis 9.0 (NG 9.0) components as follows: • The NuGenesis LMS base kit (SDMS) requires NuGenesis LMS 9.0 SDMS, which applies to Windows 10 client machines. • The NuGenesis LMS Option kit (ELN and Connectors) requires either NG LMS 9.0, NG LMS Empower Interface 2.0, or NG LMS Connectors 2.0, which are compatible with Windows 10. See also: The NuGenesis LMS 9.0 Release Notes (715005980) for complete information. Note: The NuGenesis SDMS Win 10 Client supports both Windows 10 and Windows 7. However, when using Empower 3 Service Release 4, SDMS users require the NuGenesis SDMS Win 10 Client on Windows 10. Legend for the following tables:

T Tested - Both software entries were tested and structurally validated as part of a software release. The test was performed by either the Empower or NuGenesis Programs, depending on the software release. I Incompatible - The two software entries will not work together. * Supported under risk assessment based on our knowledge of the software changes made at each release. If you encounter compatibility issues, Waters provides support in accordance with the terms of the Licenses, Warranties, and Support Services agreement. To resolve compatibility problems, you might need to upgrade to a supported platform or install a newer version of Empower software.

Table 1–1: NuGenesis SDMS and Empower compatibility matrix

NuGenesis Empower Version SDMS Version

E2 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 FR SR FR FR SR FR FR FR FR SR FR SR 5 1 1 2 2 3 4 4 4 3 5 4 Cld Cld 1.1

NG8 SDMS/ T * I T I I I I I I I I I DAR0

April 20, 2020, 716006210 Ver. 01 (previously released as Rev.A) Page 8 Table 1–1: NuGenesis SDMS and Empower compatibility matrix (continued)

NuGenesis Empower Version SDMS Version

E2 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 FR SR FR FR SR FR FR FR FR SR FR SR 5 1 1 2 2 3 4 4 4 3 5 4 Cld Cld 1.1

NG8 SMDS T * Dat T * * I I I I I I I SR1/DAR1 a Ada pter s Hotf ix avai labl e NG SDMS FR1/ T * I * * T * I I I I I I DAR2 NG8 SDMS T * I * * * T I I I I I I SR2/DAR2 NG8 SDMS T * I * * * T I I I I I I SR2/DAR3 NG8 SDMS SR2 T * I * * * * T T T * I I Win10/DAR3 HF1 NG 8 SDMS * * I * * * * T * T * T T SR2 Win10 NG8 SDMS SR2 T * I * * * * T * T T I I Win10/DAR3 HF2 NG8 SDMS SR2 * * I * * * * T * * T Test Test Win10/DAR3 ed ed HF3 with with Ser Ser vice vice Not Not ea ea NG 9.0 SDMS Ib * I * * * T * * * T T T

April 20, 2020, 716006210 Ver. 01 (previously released as Rev.A) Page 9 Table 1–1: NuGenesis SDMS and Empower compatibility matrix (continued)

NuGenesis Empower Version SDMS Version

E2 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 FR SR FR FR SR FR FR FR FR SR FR SR 5 1 1 2 2 3 4 4 4 3 5 4 Cld Cld 1.1

NG 9.0 DAR1 Ib To I To To Test T T * * T Test Test be be be ed ed ed test test test with with with ed ed ed Ser Ser Ser in in in vice vice vice DA DA DA Not Not Not R-2c R-2c R-2c ea ea ea a. The remote data adapter included in NG 9.0 DAR1 requires a manual configuration described in a service note. b. E2 FR5 operates on Windows Server 2003 and Windows XP, which are incompatible with NG LMS 9.0. c. These versions of Empower were to be supported by NG 9.0 DAR-1. As noted, they were not explicitly tested and there is an issue that will be corrected in NG 9.0 DAR2.

Table 1–2: NuGenesis LMS and Empower compatibility matrix

NuGenesis Empower Version LMS Version

E2 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 FR SR FR FR SR FR FR FR FR SR FR SR 5 1 1 2 2 3 4 4 4 3 5 4 Clo Clo ud ud 1.1

NG LMS 8 SR2 * * * * * T T *a Ib Ib Ic Ic Ic and all hot fixes NG LMS 8 * * * * * * T *a Ib Ib Ic Ic Ic Empower Interface 1.1 HF2 and earlier releases

April 20, 2020, 716006210 Ver. 01 (previously released as Rev.A) Page 10 Table 1–2: NuGenesis LMS and Empower compatibility matrix (continued)

NuGenesis Empower Version LMS Version

E2 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 FR SR FR FR SR FR FR FR FR SR FR SR 5 1 1 2 2 3 4 4 4 3 5 4 Clo Clo ud ud 1.1

NG LMS 8 I I I I I * T *a Ib Ib Ic Ic Ic Connectors 1.1 HF1 and earlier releases NG LMS 9 Id * * * I I T *a Ib Ib T T T NuGenesis LMS Id * * * * * T *a Ib Ib T T T Empower- Interface 2.0 NG LMS Id I I I I * T *a Ib Ib T T T Connectors 2.0

a. Supported on Windows 7 clients only. b. The NuGenesis LMS 8 SR-2 LMS Option kit is not included in the Empower cloud deployments. c. The NuGenesis LMS 8 SR-2 Option kit does not support Windows 10, therefore Empower versions deployed exclusively on Windows 10 clients are not compatible. d. E2 FR5 operates on Windows Server 2003 and Windows XP, which are incompatible with NG LMS 9.0.

Waters Data Converter compatibility

Empower is compatible with Waters Data Converter 2.1 HF2 (WDC 2.1 HF2) as follows: Legend:

T Tested - Both software entries were tested and structurally validated as part of a software release. The test was performed by either the Empower or NuGenesis Programs, depending on the software release. * Supported under risk assessment based on our knowledge of the software changes made at each release. If you encounter compatibility issues, Waters provides support in accordance with the terms of the Licenses, Warranties, and Support Services agreement. To resolve compatibility problems, you might need to upgrade to a supported platform or install a newer version of Empower software.

April 20, 2020, 716006210 Ver. 01 (previously released as Rev.A) Page 11 Table 1–3: Waters Data Converter and Empower compatibility matrix

WDC Version Empower Version

E2 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 E3 FR SR FR FR SR FR FR FR FR SR FR SR 5 1 1 2 2 3 4 4 4 3 5 4 Cld Cld 1.1

WDC 2.1 HF2 T T * * T * * * * * * T T

Requirement: When you install WDC 2.1, WDC 2.1 HF1 or WDC 2.1 HF2 on Windows 10, you must run both the installer and the installation qualification Check.bat file using an account with System Administrator role.

Deployment notes

Before you install the application

Before you install Empower 3 Service Release 4, back up all Empower software projects, library information, and databases, and restart the computer. You must upgrade to Empower 3 Service Release 4 from Empower 3 Feature Release 5. If you are currently using a version of Empower prior to Empower 3 Feature Release 5, you must first install Empower 3 Feature Release 5. In a client/server environment, you must configure Empower 3 Feature Release 5, including updating the Empower database with an Empower 3 Feature Release 5 client, before installing Empower 3 Service Release 4. See also: The Empower 3 Feature Release 5 Installation, Configuration, and Upgrade Guide (715006184) and the Empower 3 Feature Release 5 Release Notes (716006111) for complete installation instructions.

Creating an external tables directory for Message Center nearline tables in custom-built databases

Prerequisite: For custom-built databases only, if you are upgrading to Empower 3 Service Release 4 on a custom-built Empower database server (Red Hat or Windows-based server with your own Oracle license), you must create an external tables directory as part of your Empower 3 FR5 configuration prior to installing Empower 3 SR4. You must create a directory called EXTERNALTABLES on the database server. The EXTERNALTABLES directory stores Message Center nearline tables in Oracle external table files.

April 20, 2020, 716006210 Ver. 01 (previously released as Rev.A) Page 12 To create an external tables directory for Message Center nearline tables:

1. Update your Empower 3 FR5 database to Empower 3 SR4 by logging on to an Empower 3 node.

Note: Only an Administrator can update the database by typing the EMPOWER3CSUPDATE password. 2. From a client or server, connect to the database using sqlplus and one of these Oracle database users: millennium, system, or sys as sysdba.

3. Run the following query: