Release Configuration

Version 3.1 SP1 HF2

August 2011
© LORENZ Life Sciences Group
Table of Contents
1 About this document ................................................................................. 5
1.1 Notes ..............................................................................................................5
2 Where this software should be installed ................................................. 6
2.1 Notes for installations in a validated environment .....................................6
3 List of documentation deliverables.......................................................... 7
4 Validation Profiles ..................................................................................... 8
5 Software Installation Package .................................................................. 9
5.1 Media Content ...............................................................................................9
5.2 Version Information ....................................................................................10
5.2.1 Application Installation Path ...................................................................10
5.2.2 Configuration Installation Path................................................................11
6 Release Notes ...........................................................................................15
6.1 Target Platform Information .......................................................................15
6.2 Release compatibility information .............................................................15
6.3 Setup ............................................................................................................15
6.3.1 License Types ........................................................................................15
6.3.1.1 Basic license.................................................................................................... 15
6.3.1.2 Professional license ........................................................................................ 16
6.3.2 eValidator - New Installation ...................................................................17
6.3.3 eValidator - Updating an existing 3.0 or 3.1 installation ..........................19
6.4 New or changed features in release 3.1 SP1 HF2 .....................................20
6.4.1 Priority CRITICAL...................................................................................20
6.4.1.1 eCTDValidator-2.0-GIRS-387 (Folder name checking for EU eCTD) ............ 20
6.4.2 Priority HIGH ..........................................................................................21
6.4.2.1 eCTDValidator-2.0-GIRS-391 (Sequence not already used) .......................... 21
6.4.2.2 eCTDValidator-2.0-GIRS-385 (Date information in profile descriptions) ........ 22
6.5 Issues addressed with release 3.1 SP1 HF2 ..............................................23
6.5.1 Priority HIGH ..........................................................................................23
6.5.1.1 eCTDValidator-2.0-GIRS-392 (Font analysis may cause program crashes) .. 23
6.5.1.2 eCTDValidator-2.0-GIRS-386 (Folder name in m3-2-a-3-excipients) ............. 24
6.5.1.3 eCTDValidator-2.0-GIRS-375 (PDF target page verification problem) ........... 25
6.5.1.4 eCTDValidator-2.0-GIRS-376 (Link analysis in US application forms) ........... 26
6.5.1.5 eCTDValidator-2.0-GIRS-377 (Node extensions in EU M1) ........................... 27
6.5.1.6 eCTDValidator-2.0-GIRS-378 (PDF version checking) ................................... 28
6.5.1.7 eCTDValidator-2.0-GIRS-382 (Duplicated messages for NeeS naming) ....... 29

© LORENZ Life Sciences Group 2

 6.5.1.8 eCTDValidator-2.0-GIRS-383 (PDF analysis stops for fields with null name) 30
6.5.1.9 eCTDValidator-2.0-GIRS-384 (Missing related sequences) ........................... 31
7 Appendix ...................................................................................................32
7.1 Customizing the help texts and names for the built-in standard rules ...32
7.2 Customizing the help texts and names for custom rules .........................33

© LORENZ Life Sciences Group 3

Revision History
Revision Date Modifier Description

1.00 20-Jul-2011 J. Wermusch Initial version for release 3.1 SP1 HF2

1.10 25-Jul-2011 J. Wermusch Added eCTDValidator-2.0-GIRS-0386

Added eCTDValidator-2.0-GIRS-0387

1.20 05-Aug-2011 J. Wermusch Updated eCTDValidator-2.0-GIRS-0387

1.30 08-Aug-2011 J. Wermusch Added eCTDValidator-2.0-GIRS-0391

Added eCTDValidator-2.0-GIRS-0392

© LORENZ Life Sciences Group 4

1 ABOUT THIS DOCUMENT
This document contains the configuration details, the release notes and additional
information for LORENZ eValidator 3.1 SP1 HF2, including:
 The content of the new shipment.
 Compatibility with other components
 Installation instructions

1.1 Notes
 Throughout this document, the phrase eValidator refers to the LORENZ
eValidator product.
 Throughout this document, the phrase eValidator installation folder refers to the
folder where the eValidator has been or shall be installed to (this is usually the
folder named C:\Program Files\LORENZ Life Sciences\LORENZ eValidator).
 Throughout this document, the phrase eValidator configuration folder refers to
the folder where the eValidator configuration files have been or shall be
installed to (this is the sub-folder named LORENZ Life Sciences\eValidator in
the CommonAppData folder.
 The CommonAppData location depends on the operating system: for Windows
XP and Windows Server 2003, this folder is C:\Documents and Settings\All
Users\Application Data, for Windows Vista, Windows 7, and Windows Server
2008, this folder is C:\ProgramData.
 Technically the LORENZ eValidator 3.1 SP1 HF2 is referred to as version
3.1.1.2, for example in the file versions listed in chapter 5.2.

© LORENZ Life Sciences Group 5

2 WHERE THIS SOFTWARE SHOULD BE INSTALLED
This software release can be installed on both client and server computers. It may be
used side by side with the docuBridge client.
All customers with an existing installation of a previous release should consider
installing this release because it is a significant update and contains some new
important features.

2.1 Notes for installations in a validated environment

This is a hotfix release. Therefore, according to the implemented change control
procedures, (re-)validation steps will be required when putting the application into
operational usage. This depends on the validation policy implemented at the customer
site.
LORENZ strongly suggests performing Installation Qualification (IQ), Operational
Qualification (OQ) and Performance Qualification (PQ) based on a Validation Plan
(VP). In addition, a thorough risk analysis and risk controlling should be performed.
The eValidator does not store or modify any electronic records for electronic
submissions. However, due to the importance of correctness for the validation results,
LORENZ recommends (re-)validating the product.
Please note the following general hints for the Installation Qualification (IQ):
Both the setup package and the software binaries have been signed electronically to
comply with the new security guidelines on Windows Vista, Windows Server 2008, and
Windows 7. The LORENZ certificate has been issued by GlobalSign
(www.globalsign.com). If you need additional details about the certificate used, please
contact LORENZ support.
Please do only install LORENZ eValidator software that has a genuine electronic
signature issued to LORENZ Bridge Software GmbH. The signature will be shown
upon installation (see chapter 6.3) and can also be verified through the file properties of
any binary file contained in the shipment.

© LORENZ Life Sciences Group 6

3 LIST OF DOCUMENTATION DELIVERABLES
The distribution of release 3.1 SP1 HF2 for eValidator contains the following
documentation:
 The updated Functional Specification document (FSP)
 This release configuration document
 Several whitepapers describing how the eValidator addresses the official
validation criteria as published by agencies (please refer to section 6.4 for
details how to use the whitepapers).

© LORENZ Life Sciences Group 7

4 VALIDATION PROFILES
Please refer to sections 6.4 and 6.5 to check if any changes have been made to the
protected validation profiles that apply to your use cases.
For a comprehensive list of changes made in the previous releases, please refer to the
release documentation for versions 3.1 SP1 and 3.1 SP1 HF1.

© LORENZ Life Sciences Group 8

5 SOFTWARE INSTALLATION PACKAGE
The distribution contains software setup for eValidator 3.1 SP1 HF2 (which will also
install the eValidator Editor executable). The distribution is delivered as an
uncompressed setup, which may be used for both new and upgrade installations.
The setup is provided as a full setup. It does not require any previous installation. If a
previous version of the LORENZ eValidator is found during installation, it will be
updated.
eValidator
This application allows verifying and validating electronic submissions purportedly
conforming to the ICH eCTD standard (see www.ich.org) based on configured check
options and dynamic verification rules. Validation results will be created as XML and as
HTML reports; adequate XSL style sheets for viewing the report content in a web
browser are also provided. LORENZ will periodically provide updates for the
configuration base to keep the eValidator synchronized with the official specifications.
Since this only affects the XML configuration files, reinstalling the application will not be
necessary.
The eValidator also supports validating non eCTD submissions (NeeS). For details
about the predefined validation rules for non eCTD submissions, please refer to the
user guide or the Functional Specification (FSP).
eValidator Editor
This application allows editing the eValidator validation rule configuration files. To use
this application, you need a professional license.

5.1 Media Content

Folder name: Setup eValidator 3.1 SP1 HF2

© LORENZ Life Sciences Group 9

CommonAppData:
This subfolder contains the configuration files, the DTDs and the XML schemas for the
index file versions (ICH backbones, regional and STF files) supported by the
eValidator. Please refer to the next section for a complete list of these files.

5.2 Version Information

5.2.1 Application Installation Path

Default (32 bit systems):
C:\Program Files\LORENZ Life Sciences\LORENZ eValidator
Default (64 bit systems):
C:\Program Files\LORENZ Life Sciences(x86)\LORENZ eValidator

File Name Version Notes

BouncyCastle.Crypto.dll 1.6.1.0

CoreServicesProxy.dll 5.0.8.0

docuBridge.Globals.dll 5.1.0.0 Updated

docuBridge.ListViewManager.dll 3.0.0.0

eValidator.exe 3.1.1.16 Updated

eValidatorCore.dll 3.1.1.16 Updated

eValidatorEditor.exe 3.1.1.16 Updated

eValidatorGuide.pdf 7.00

ICSharpCode.SharpZipLib.DLL 0.84.0.0

Lorenz.YAPP.dll 1.0.23.0 Updated

Lorenz.Shared.dll 1.0.0.1

NotificationServiceProxy.dll 1.0.0.0

OSInfo.dll 1.0.3952.18671

SplashResource.dll 3.1.0.0

© LORENZ Life Sciences Group 10

5.2.2 Configuration Installation Path
Windows XP:
C:\Documents and Settings\All Users\Application Data\LORENZ Life
Sciences\eValidator
Windows Vista, Windows 7:
C:\ProgramData\LORENZ Life Sciences\eValidator

File Name Version Notes

eva.sd6 n/a

eValidator.exe.config n/a

eValidatorAux.xslt n/a

eValidatorAux2.xslt n/a

eValidatorMain.xslt n/a Updated

eValidatorCOVER.xslt n/a Updated

iso_3166-1_list_en.xml n/a

LORENZ.docuBridge.eValidator.de.resources.resx 3.1.1.0 Updated

LORENZ.docuBridge.eValidator.en.resources.resx 3.1.1.0 Updated

LORENZ.docuBridge.eValidator.fr.resources.resx 3.1.1.0 Updated

LORENZ.docuBridge.eValidator.ja.resources.resx 3.1.1.0 Updated

Profile_CA.xml n/a

Profile_CH.xml n/a

Profile_EU1.xml n/a

Profile_EU2.xml n/a Updated

Profile_EU2_advanced.xml n/a Updated

Profile_HR.xml n/a

Profile_JP.xml n/a

Profile_PL.xml n/a

Profile_US1.xml n/a

Profile_US2.xml n/a

version.xml n/a Updated

DTDs\CustomRulesAndOptions_eCTD.xml n/a

DTDs\validate_eCTD.xml n/a

DTDs\naming_eCTD.xml n/a Updated

DTDs\naming_eCTD_EU2.xml n/a Updated

© LORENZ Life Sciences Group 11

 File Name Version Notes

DTDs\CustomRulesAndOptions_NeeS.xml n/a

DTDs\validate_NeeS.xml n/a Updated

DTDs\naming_NeeS.xml n/a Updated

DTDs\naming_NeeS_EU2.xml n/a Updated

DTDs\ectd-3.00\dtd\ich-ectd-3-0.dtd (3.0)

DTDs\ectd-3.2\dtd\ich-ectd-3-2.dtd (3.2)

DTDs\regional-ch-1.0\dtd\ch-regional.dtd (1.0)

DTDs\regional-ch-1.0\dtd\ch-leaf.mod (1.0)

DTDs\regional-ch-1.0\dtd\ch-envelope.mod (1.0)

DTDs\regional-ch-1.0.1\dtd\ch-regional.dtd (1.0.1)

DTDs\regional-ch-1.0.1\dtd\ch-leaf.mod (1.0.1)

DTDs\regional-ch-1.0.1\dtd\ch-envelope.mod (1.0.1)

DTDs\regional-ch-1.1\dtd\ch-regional.dtd (1.1)

DTDs\regional-ch-1.1\dtd\ch-leaf.mod (1.1)

DTDs\regional-ch-1.1\dtd\ch-envelope.mod (1.1)

DTDs\regional-ch-1.1\style\ectd-2-0.xsl (2.0)

DTDs\regional-ch-1.1\style\ch-regional.xsl (1.0)

DTDs\regional-ca-0.9\dtd\ca-regional-0-9.dtd (0.9)

DTDs\regional-ca-1.0\dtd\ca-regional-1-0.dtd (1.0)

DTDs\regional-eu-0.9\dtd\eu-envelope.mod (0.9)

DTDs\regional-eu-0.9\dtd\eu-index.dtd (0.9)

DTDs\regional-eu-0.9\dtd\eu-leaf.mod (0.9)

DTDs\regional-eu-0.92\dtd\eu-envelope.mod (0.92)

DTDs\regional-eu-0.92\dtd\eu-index.dtd (0.92)

DTDs\regional-eu-0.92\dtd\eu-regional.mod (0.92)

DTDs\regional-eu-1.0\dtd\eu-envelope.mod (1.0)

DTDs\regional-eu-1.0\dtd\eu-regional.dtd (1.0)

DTDs\regional-eu-1.0\dtd\eu-leaf.mod (1.0)

DTDs\regional-eu-1.1\dtd\eu-envelope.mod (1.1)

DTDs\regional-eu-1.1\dtd\eu-regional.dtd (1.1)

DTDs\regional-eu-1.1\dtd\eu-leaf.mod (1.1)

DTDs\regional-eu-1.2\dtd\eu-leaf.mod (1.2)

© LORENZ Life Sciences Group 12

 File Name Version Notes

DTDs\regional-eu-1.2\dtd\eu-envelope.mod (1.2)

DTDs\regional-eu-1.2\dtd\eu-regional.dtd (1.2)

DTDs\regional-eu-1.2.1\dtd\eu-leaf.mod (1.2.1)

DTDs\regional-eu-1.2.1\dtd\eu-envelope.mod (1.2.1)

DTDs\regional-eu-1.2.1\dtd\eu-regional.dtd (1.2.1)

DTDs\regional-eu-1.3\dtd\eu-leaf.mod (1.3)

DTDs\regional-eu-1.3\dtd\eu-envelope.mod (1.3)

DTDs\regional-eu-1.3\dtd\eu-regional.dtd (1.3)

DTDs\regional-eu-1.4\dtd\eu-leaf.mod (1.4)

DTDs\regional-eu-1.4\dtd\eu-envelope.mod (1.4)

DTDs\regional-eu-1.4\dtd\eu-regional.dtd (1.4)

DTDs\regional-eu-1.4\style\ectd-2-0.xsl (2.0)

DTDs\regional-eu-1.4\style\eu-regional.xsl (1.4)

DTDs\regional-eu-applicationform-2.1\dtd\eu-
(2.1)
application.dtd

DTDs\regional-eu-renewlform-0.5\dtd\eu-renewal.dtd (0.5)

DTDs\regional-eu-trackingtable-0.1\dtd\tracking-
(0.1)
table.dtd

DTDs\regional-eu-variationformform-0.5\dtd\eu-
(1.1)
variation.dtd

DTDs\regional-hr-1.4\dtd\hr-envelope.mod (1.4)

DTDs\regional-hr-1.4\dtd\hr-regional.dtd (1.4)

DTDs\regional-hr-1.4\dtd\hr-leaf.mod (1.4)

DTDs\regional-hr-1.4\style\ectd-2-0.xsl (2.0)

DTDs\regional-hr-1.4\style\hr-regional.xsl (1.4)

DTDs\regional-jp-1.0\dtd\jp-regional-1-0.xsd (1.0)

DTDs\regional-jp-1.0\dtd\xlink.xsd (1.0)

DTDs\regional-us-2.0\dtd\us-regional-v2-0.dtd (2.0)

DTDs\regional-us-2.01\dtd\us-regional-v2-01.dtd (2.01)

DTDs\regional-us-2.01\style\ectd-2-0.xsl (2.0)

DTDs\regional-us-2.01\style\us-regional.xsl (2.0)

DTDs\study-2.0\dtd\ich-stf.dtd (2.0)

DTDs\study-2.0\style\valid-values.xml (2.0)

DTDs\study-2.2\dtd\ich-stf-v2-2.dtd (2.2)

© LORENZ Life Sciences Group 13

 File Name Version Notes

DTDs\study-2.2\style\valid-values.xml (2.2)

DTDs\study-2.2\style\ich-stf-stylesheet-2-2a.xsl (2.2a)

© LORENZ Life Sciences Group 14

6 RELEASE NOTES
6.1 Target Platform Information
The application has been tested and released for the following operating system
platforms:
 Microsoft Windows XP Professional SP2
 Microsoft Windows XP Professional SP3
 Microsoft Windows Vista
 Microsoft Windows Vista SP1
 Microsoft Windows 7
 Microsoft Windows Server 2003 SP1
 Microsoft Windows Server 2003 SP2
The application setup requires Microsoft Windows Installer 3.1, which will be installed
automatically if not already existing on the target computer.
Both the eValidator and the eValidator Editor are native Microsoft .NET 3.5 SP1
assemblies. Therefore the .NET 3.5 SP1 runtime is required to use the applications.
The setup will automatically install the .NET framework if not already present on the
target computer (this requires an Internet connection).

6.2 Release compatibility information

There are no compatibility issues for eValidator 3.1 SP1 HF2 related to previous
versions. It can be used side by side with the docuBridge client.
Any versions before LORENZ eValidator 3.0 will not be removed or upgraded by the
eValidator 3.1 SP1 HF2 setup. If you want to remove such a previous version, you
need to uninstall it manually via the Add/Remove Programs dialog in the Control
Panel or by re-running the setup program that installed the version.

6.3 Setup
Prior to installing eValidator, please unzip the distribution files to a temporary directory.
If you have received the product on a CD or DVD, please copy the files to a temporary
location on a hard disk and remove the “read-only” flags of these files before you
continue.
The setup is provided as a full setup. It does not require any previous installation. If a
previous version of the LORENZ eValidator is found during installation, it will be
updated (please see section 6.3.3 for additional details).

6.3.1 License Types

For the LORENZ eValidator, two different license types are available:

6.3.1.1 Basic license

This is a free of charge license which allows running validations for eCTD or non eCTD
submissions. Several features have been disabled for this license type:
© LORENZ Life Sciences Group 15
  You cannot use customized profiles or change the report branding text and
logo.
 Using the LORENZ eValidator in batch mode is not supported.
 The eValidator Editor cannot be used.
 Only English and German localization is available.
 You cannot create or use custom profiles.
 You cannot change any severity settings for the validation rules.
 You cannot change the profile you have selected on first start of the software.
Only reinstalling the software will allow re-selecting the profile.
 If you are using a “branded” version of the eValidator (such as BfArM eValidator
or AGES eValidator), changing the profile is limited to the EU related profiles.
 You cannot install or run the software on a server operating system like
Microsoft Windows Server 2003 or 2008.
 You will not get the summary report in addition to the full validation report.

6.3.1.2 Professional license

This license, which needs to be purchased, does not have any functional limitations. It
includes additional localization languages (e.g. French and Japanese). However, the
available Backbone and Regional versions may depend on the modules you
purchased. For additional information, please contact LORENZ sales or talk to your
LORENZ representative.

© LORENZ Life Sciences Group 16

6.3.2 eValidator - New Installation
By executing the following steps you will create a new installation.
1. Navigate to the setup folder Setup eValidator 3.1 SP1 HF2 and start the file
setup.exe.
In case Windows Installer 3.1 or Microsoft .NET 3.5 SP1 runtime is not already
present, these components will be installed first (requires an Internet connection).
Acknowledge the confirmation dialogs and follow the instructions on the screen.
Completing the installation of these components might require restarting the
computer.
2. The eValidator 3.1 SP1 HF1 installation wizard will be started.
On Windows Vista, Windows 7 and Windows Server 2008, you will get a
confirmation message like the one in the following picture showing the publishers
identity:

3. To save you from fraud by tampered software packages, please acknowledge this
message only of the Verified Publisher is LORENZ Bridge Software GmbH. You
can click on Show details to see additional information about the publisher's
identity.
4. Follow the instructions displayed to complete the installation. For a quick and easy
procedure, it is recommended to accept the default settings provided by the wizard.
Please do not select a destination folder, where a previous version has already
been installed to (this would override the old version but not properly uninstall it).
5. A new desktop shortcut (LORENZ eValidator) and a new start menu item will be
created (LORENZ Life Sciences\eValidator). Both shortcuts can be used to start the
application.
6. Start the eValidator.
If this is the first time you start the application after installing it and you do not
already have registered the product, you will be directed to the registration window
of the application. For Basic licenses (i.e. you are planning to use the free
version), please proceed as follows (for the professional license, these steps are
not required).
6.1. Please fill out the required fields marked in yellow and send the data to the
LORENZ registration server. LORENZ would appreciate if you could also
provide some additional information by filling out the optional form fields,
since this would provide us with an easier way contacting you in case of
any assistance needed. The Basic license is free of charge, so the
registration will not cause any fee to be paid.

© LORENZ Life Sciences Group 17

 6.2. Click on Send Registration Data ... to send the data to the LORENZ
registration server. The data will be sent over a secure connection (SSL is
being used).
The server address is
https://evalidator.docubridge.com/evalidatorregservice.asmx.
You do not need to enter this address, it is automatically used by the
eValidator application when sending the data. No additional information is
collected other than the data you entered in the form.
6.3. A serial number will be generated and sent back to the application
immediately. It will automatically unlock your license so that you can start
using the LORENZ eValidator right now.
6.4. In case you do not want to register at all you may click the Skip
Registration button.
6.5. In case you cannot or do not want to send the registration data to the
LORENZ registration server automatically, you can also save the
registration data to a file and send this file to LORENZ support via e-mail.
To do so, please click on the Save to file ... button. If necessary, LORENZ
support will then send you a serial number which you can enter manually to
unlock the license upon next start of the program.
6.6. The registration is done and saved on a per-user-basis. Though it is not
necessary for using the software, LORENZ would appreciate that any
additional user on the same workstation would also register.
6.7. In case you want to notify about any changes in your registration data once
you have completed registration, you can click on the Change Registration
button to re-enable the registration fields. Otherwise, these fields will be
disabled when the registration has completed.
For Professional licenses, no registration is required; the license file you received
from LORENZ has been personalized for you. You only need to enter the serial
number, provided to you by LORENZ, to unlock the license so that you can start using
the software. When you start the program, you will automatically be directed to the
registration screen, where you can enter the serial number. Note that all remaining
fields are disabled since your personal information is contained in your license file (and
will be shown once the license has been unlocked). Please click on the Apply button to
unlock the license.

© LORENZ Life Sciences Group 18

6.3.3 eValidator - Updating an existing 3.0 or 3.1 installation
Updating a LORENZ eValidator 3.x installation works similar to the steps described for
a new installation (see 6.3.2).
For older versions (before 3.0) please uninstall the program first via the Add/Remove
Programs dialog in the Control Panel or by re-running the setup program that
installed the version.

© LORENZ Life Sciences Group 19

6.4 New or changed features in release 3.1 SP1 HF2
Note for validated environments: The recommendations given in the following table
only apply for customers upgrading from an existing 3.1 or later release. All other
customers should consider performing a full validation according to the policy defined
in the organization.

6.4.1 Priority CRITICAL

6.4.1.1 eCTDValidator-2.0-GIRS-387 (Folder name checking for EU eCTD)

Description:
The folder name checking for eCTD submissions will be handled in non-restricted
mode, i.e. additional subfolders below the required folder structures (as defined by the
new EU eCTD validation criteria v3.1) will be accepted without warnings for M1, M2,
M3, M4, and M5. This is the same behavior as used with LORENZ eValidator 3.1 and
previous releases.
So for example study report folders in M4, or separate folders for CRFs as subfolders
for M5 study report folders will no longer be reported as warnings.
The decision to go back to the non-restricted folder name checking approach is based
on an agreement with agencies and other validation tool vendors (as of 30-July-2011) .
Note that the file name checking for eCTD will not be changed. It still follows the
name definitions given in the new EU eCTD validation criteria v3.1.
Folder name checking for NeeS submissions will still be executed in strict mode, i.e.
the folder structure as defined by the new EU NeeS validation criteria v2.1 must be
followed. No additional subfolders will be accepted. Furthermore please note that files
may only be placed at the lowest level of the folder structures, as defined by the new
EU NeeS validation criteria v2.1. While previous versions of the LORENZ eValidator
did not always enforce this it will now be handled strictly according to the official NeeS
regulations.
Affected profiles: EU (eCTD v3.1 and NeeS v2.1)

Validation Impact
IQ n/a
OQ n/a
PQ All customers using the new EU profiles should adjust and repeat their
corresponding test scripts in order to verify that the new folder name
regulations are in effect.

© LORENZ Life Sciences Group 20

6.4.2 Priority HIGH

6.4.2.1 eCTDValidator-2.0-GIRS-391 (Sequence not already used)

Description:
For EU profiles, the rule "EU Regional 1.4/Sequence number not already used" should
not report an error when one or more previous index files cannot be found or read.
This has been resolved with HF2.

Affected profiles: EU (eCTD v3.1), HR

Validation Impact
IQ n/a
OQ n/a
PQ Error messages in the validation report caused by invalid or non-existing
index files from previous sequences indicate that something was not correct
when those were created. For the current sequence however this does not
necessarily provide any useful information. Hence we decided to remove the
corresponding messages from the report. Customers may want to verify this
by re-validating submissions where the LORENZ eValidator printed error
messages due to problems with previous index files when trying to check if
the sequence number has already been used.

© LORENZ Life Sciences Group 21

6.4.2.2 eCTDValidator-2.0-GIRS-385 (Date information in profile descriptions)
Description:
The profile descriptions "USA (FDA) [valid until May 2011]" and "USA (FDA) [effective
June 2011]" are no longer correct. The FDA has announced that the new validation
criteria will be valid starting November 2011. Hence the date information has been
removed from the profile descriptions (and replaced with the criteria set versions).
The profile descriptions “Europe - EU, all countries [effective 01-Sep-2011], Advanced”,
“Europe - EU, all countries [effective 01-Sep-2011]”, and “Europe - EU, all countries
[valid until 31-Aug-2011]” have also been updated. Instead of the date information the
validation criteria set versions will be displayed.

Affected profiles: n/a

Validation Impact
IQ n/a
OQ n/a
PQ Make sure adjusting your operational procedures when selecting the
appropriate profile for your application.

© LORENZ Life Sciences Group 22

6.5 Issues addressed with release 3.1 SP1 HF2
Note for validated environments: The recommendations given in the following table
only apply for customers upgrading from an existing 3.1 or a later release. All other
customers should consider performing a full validation according to the policy defined
in the organization.

6.5.1 Priority HIGH

6.5.1.1 eCTDValidator-2.0-GIRS-392 (Font analysis may cause program crashes)

Description:
The font analysis in the US profile sometimes crashes the whole eValidator program
and no report is being created. Even though this might be caused by reference loops
inside the PDF document the application should not crash then.
This has been resolved with HF2.

Affected profiles: US (version 2.0)

Validation Impact
IQ n/a
OQ n/a
PQ Customers who encountered program crashes related to the issue described
above should consider repeating the validation for the submissions where the
crashes occurred.

© LORENZ Life Sciences Group 23

6.5.1.2 eCTDValidator-2.0-GIRS-386 (Folder name in m3-2-a-3-excipients)
Description:
In the folder name check the following subfolder name is incorrectly configured:
"m3\32-body-data\32a-app\32a3-*\"
It should read "m3\32-body-data\32a-app\32a3-excip-*\"
This has been resolved with HF2.

Affected profiles: EU (all profiles), HR, PL, CH, US (version 1.0 and 2.0), JP

Validation Impact
IQ n/a
OQ n/a
PQ Due to the incorrectly configured folder name in the LORENZ eValidator
setup, an invalid folder name at this level would not have been reported by
the LORENZ eValidator (the old configuration was too tolerant). Customers
who noticed that the LORENZ eValidator did not report a folder name
violation here (while other validators might have) should consider repeating
the corresponding test script to verify that the issue has been resolved.

© LORENZ Life Sciences Group 24

6.5.1.3 eCTDValidator-2.0-GIRS-375 (PDF target page verification problem)
Description:
In previous versions when analyzing target pages for hyperlinks and bookmarks, the
eValidator did not take into account that the destination document might be a non-PDF
document. However in such cases the rule "Named destination/page check" does not
apply. Currently it reports warnings for those links.
This has been fixed with HF2.

Affected Profiles: US (version 2.0 only)

Validation Impact
IQ n/a
OQ n/a
PQ Customers who encountered error messages due to this problem (currently
the rule is enabled in the new US profile only) should repeat the
corresponding validation scripts to verify that the issue has been resolved.

© LORENZ Life Sciences Group 25

6.5.1.4 eCTDValidator-2.0-GIRS-376 (Link analysis in US application forms)
Description:
US submissions:
For US submissions the use of fillable electronic forms is strongly recommended.
Because those forms are encrypted the LORENZ eValidator ignores them in protection
analysis. There are however warnings reported for hyperlink and bookmark analysis.
This has been fixed with HF2 and the link analysis will now be skipped for the official
electronic forms.
Affected Profiles: US (version 2.0 only)

Validation Impact
IQ n/a
OQ n/a
PQ Customers who encountered warning messages for hyperlinks and
bookmarks contained in US application form documents should repeat the
corresponding validation scripts to verify that the warnings no longer appear.

© LORENZ Life Sciences Group 26

6.5.1.5 eCTDValidator-2.0-GIRS-377 (Node extensions in EU M1)
Description:
EU submissions:
Using of node extensions in EU M1 for country specific elements leads to false naming
convention violation messages in the validation report.
Technical background: This is caused by the country attribute, which will be checked
for being part of the actual folder structure. The checking is performed against the
direct parent node in the XML index file. However with node extension there might be
additional levels between leaf and country attribute.
The problem has been resolved with HF2.
Affected Profiles: EU (all profiles, but for eCTD only), HR (eCTD only), PL (eCTD only)

Validation Impact
IQ n/a
OQ n/a
PQ Customers who encountered error messages for folder names in EU M1
related to the issue described above should repeat the corresponding
validation scripts to verify that the error messages no longer appear.

© LORENZ Life Sciences Group 27

6.5.1.6 eCTDValidator-2.0-GIRS-378 (PDF version checking)
Description:
EU submissions:
There is an error in the PDF version list for the new EU profile (for eCTD v3.1 and
NeeS v2.1). It should be 1.4,[1.5],[1.6],[1.7],[1.8]. Currently version [1.7] is specified as
[1,7] (comma instead of dot). This leads to error messages for PDF documents with
version 1.7, but a warning would be expected.
The problem has been resolved with HF2.
Affected Profiles: EU (eCTD v3.1 and NeeS v2.1)

Validation Impact
IQ n/a
OQ n/a
PQ Customers who encountered error messages for PDF documents with
version 1.7 should repeat the corresponding test scripts verifying that the
errors have been replaced with warnings.

© LORENZ Life Sciences Group 28

6.5.1.7 eCTDValidator-2.0-GIRS-382 (Duplicated messages for NeeS naming)
Description:
EU NeeS:
For NeeS, the file name checks in "ICH Backbone - 3.2/Adherence to Naming
Conventions (root, m2, m3)" do not only report invalid file names but also invalid folder
names. Invalid folder names however are also reported by "ICH Backbone -
3.2/Adherence to Naming Conventions (folders)". The file name check should not
repeat such messages.
The problem has been resolved with HF2.
Affected Profiles: EU (NeeS v2.1)

Validation Impact
IQ n/a
OQ n/a
PQ Customers who encountered duplicated messages for invalid NeeS file
names should consider repeating the corresponding test scripts to verify that
the issue has been resolved.

© LORENZ Life Sciences Group 29

6.5.1.8 eCTDValidator-2.0-GIRS-383 (PDF analysis stops for fields with null name)
Description:
US Submissions:
The eValidator stops validation before completion when the submission includes PDF
fillable forms with one or more fields having a null value name.
The problem has been resolved with HF2.
Affected Profiles: US (version 2.0 only)

Validation Impact
IQ n/a
OQ n/a
PQ Customers who encountered error messages due to this problem (currently
the corresponding PDF verification rules are enabled in the new US profile
only – the rules are checking the correctness of the information provided in
the US application forms) should repeat the corresponding validation scripts
to verify that the issue has been resolved.

© LORENZ Life Sciences Group 30

6.5.1.9 eCTDValidator-2.0-GIRS-384 (Missing related sequences)
Description:
US Submissions:
When related-sequence-number attribute references a submission that is not available
the LORENZ eValidator is reporting the following error:
Validation check:
Only top level submissions can have child submissions
Error:
File cannot be loaded: The submission specified at related-sequence-
number is not a top level submission

The eValidator should not report this as an error but should indicate it was not able to
perform the check because the related sequence could not be found. Also, it should
indicate what the related-sequence-number is so the user can locate it.

The problem has been resolved with HF2.

Affected Profiles: US (versions 1.0 and 2.0)

Validation Impact
IQ n/a
OQ n/a
PQ This is just a reporting enhancement. Customers may want to verify that the
report message is now indicating that the missing sequence could not be
loaded (together with the number of the sequence).

© LORENZ Life Sciences Group 31

7 APPENDIX
7.1 Customizing the help texts and names for the built-in standard
rules

Caution!

Improperly changing these texts might cause program failures. You must test your
changes thoroughly before releasing them for operational use.

Only the professional version of the LORENZ eValidator allows customizing help texts
and names. Doing this with the Basic version would invalidate the resource files and
the program would no longer be operable.

To customize the standard check option names (rule names) and the related help texts
follow these steps:
1. Locate the file LORENZ.eValidator.en.resources.resx in the eValidator
configuration folder.
2. Open the file in an XML editor (you may also use Windows notepad if you wish but
this is less comfortable).
3. Edit the file to make your customizations. Please note the comments given for
every single resource ID. The table below shows which IDs belong to which group
of resource.
4. Save the file.
5. Restart the eValidator program.
Note:
You may also apply this procedure for languages other than English (en). This requires
a file named LORENZ.eValidator.xx.resources.resx, where xx is the 2-letter
standard language code. Currently, there are localizations available for German,
Japanese, and French (i.e. xx equals de, ja, or fr). For these languages, the
necessary files will be installed automatically. Please ask the LORENZ support for
other language resources available. Additional language files must be copied into the
eValidator installation folder, where the English file is located.

© LORENZ Life Sciences Group 32

7.2 Customizing the help texts and names for custom rules

Caution! Please make sure you have a valid and up-to-date backup copy of your
validate_*.xml files before executing the following procedure.

To customize the names and the related help texts for the custom rules follow these
steps (assuming that you have purchased the advanced edit license):
1. Start eValidator Editor from the Options tab in the main form (requires a
professional license).
2. Open the validate_*.xml file (* means eCTD or NeeS) from the eValidator
configuration folder (refer to the subfolder DTDs to locate these files).
3. Expand the backbones tree node and the appropriate sub-nodes to locate the
custom rule you want to edit.
4. Click on the node with the name of the rule.
5. On the right pane, get to the section help text and make your customizations to the
text.
6. On the right pane, get to the section Description (rule name) and make your
customizations to the text.
7. Save the file.
Close the editor. The eValidator main form will be restored and the changes will take
effect immediately.

© LORENZ Life Sciences Group 33