Release Configuration Sheet

Transcription

1 Release Configuration Sheet docubridge ONE 18.2 October 2018 LORENZ Life Sciences Group

2 Table of Contents 1. Getting Started Introduction How this guide is organized Where this Release should be installed Installing into a validated environment Release Notes Distribution Methods Product Documentation Release Impact Information Changes since the docubridge ONE Release New Features & Enhancements Submission Workbench docubridge Explorer Specification Support Other Items Addressed Issues Submission Workbench Specification Support Other Items Known Issues...10

3 1. Getting Started 1.1 Introduction This document is the Release Configuration Sheet (RCS) for docubridge ONE The intention of Release Configuration Sheets, is to provide an overview of the release, its scope and distribution and - most importantly - impact on existing systems, issues addressed or features that have been added or modified. 1.2 How this guide is organized This guide is organized in three Chapters: Chapter 1 contains general information about the release and the Release Configuration Sheet as well as an indication about expected target systems. Chapter 2 deals with the actual Release Notes including Distribution Media, Product Documentation and Release Impact Information. Chapter 3 contains a brief narrative description of enhancements and addressed issues. Each item can be used to refer to the issues tracked under LORENZ Help Desk to allow every customer to identify items fixed on their behalf. 1.3 Where this Release should be installed This release is a Major Release of docubridge ONE. It contains a complete copy of the docubridge application and, therefore, can be applied to systems running any version of docubridge ONE. If you are upgrading from a previous version of docubridge ONE, please carefully review the information provided in this document, as well as the Release Configuration Sheets for all the versions between your currently installed version of docubridge and this release to estimate the potential impact of this update. This release should be considered for installation: In a docubridge ONE environment with a version of the application below docubridge ONE In an environment running docubridge ONE , where this release adds significant value to the system owner(s). The installation of this Major Release is not mandatory. 1.4 Installing into a validated environment LORENZ suggests a careful analysis of the changes and/or issues of interest provided in Chapter 3 of this document, to assess necessary validation activities. LORENZ Life Sciences Group 3

4 2. Release Notes 2.1 Distribution Methods LORENZ docubridge ONE 18.2 can be purchased and downloaded via LORENZ ID available on Product Documentation This version of docubridge ONE 18.2 was created with the following documentation items: Items marked with an * have NOT been changed in this release. Documentation Item Reference Guide* Release Configuration Sheet System Requirements Content Describes the installation and usage of docubridge ONE. Implemented and accessible via LORENZ ID web-presence. This document, outlining changes to the release compared to the previous version. A current version of the docubridge ONE System Requirements document. Table Release Impact Information This release of docubridge ONE 18.2 is a Major Release. Component Microsoft SQL LocalDB (Express) Database An impact on the Microsoft SQL LocalDB (Express) Database is given if a release applies changes to any of the information stored in the database. This includes changes to the design of database tables, changes to stored procedures, changes to triggers, changes to index tables or any migration applied to existing data. Application - docubridgeexplorer.exe An impact on the docubridge Explorer Executable is given if the executable itself or any of its referenced binary libraries is changed. Table 2-2 Affected LORENZ Life Sciences Group 4

5 3. Changes since the docubridge ONE Release 3.1 New Features & Enhancements Submission Workbench - Table docubridge Explorer DB Enhanced Drag & Drop Support It is now possible to drag & drop docubridge objects outside docubridge (for example, to Microsoft Outlook or Microsoft Word) to create links to the object. The new drag & drop functionality has been added to the docubridge Explorer and the following panes in the Submission Workbench: Node Content, Find Nodes, and Content Catalog. Table Specification Support DB-9959 LLS-18688, LLS-22009, LLS-22539, LLS-22556, LLS-23095, LLS-22564, LLS STF Publishing with Sequence Numbers to Support Style sheet v. 2.3 The docubridge STF publishing has been adapted to always include the sequence in the xlink:href atttribute, based on the recommendation by ICH (see ectd v1.31 item 83 in This change is considered a workaround for the incorrect stf-stylesheet v2.3. DB-9933 LLS Support Publishing of Optional Folders for EU Validation The docubridge publishing and import has been extended to support the definition of an additional optional subfolders in the ectd sections 3.2.A.1, 3.2.A.2, 3.2.A.3, 3.3, 4.3 and 5.4, as defined in the current EU Validation Criteria. LORENZ Life Sciences Group 5

6 DB Support EU Control Strategy Summary Documents DB-9901 LLS Support Nested Non-STF Nodes DB-9886 LLS Publish VNeeS Applications in PDF or webview Formats The docubridge publishing and import has been enhanced to support esubmission codes for Control Strategy Summary documents in the sections 3.2.S.4 and 3.2.P.5, as defined in the EU ectd Validation Criteria (File-Folder Structure Names). The docubridge node configuration has been enhanced to support the assignment of the esubmission code 'non-stf' on nodes which parent node has already the esubmission code 'non-stf' assigned. This way it is possible to create nested non-stf nodes. With docubridge you can now publish VNeeS applications in the PDF and webview formats. Table Other Items DB Default Setting for Import Orphan Files DB Remove Deprecated User Functions during Installation DB ectd Import: Performance issue for LCM applications DB ectd Import: Handling of Deletes with no leaf title DB ectd Import of Erroneous ectd Backbone Files With the import has been enhanced to support the import of orphan files (see DB-9522 in the Release Configuration Sheet of db ). This import functionality is by default turned on in When upgrading to docubridge 18.2, the database upgrade script automatically removes the deprecated user functions _MVO, _SPT and _ASL from the database. The overall performance of ectd imports, especially for large life cycle applications with many sequences and many leaves, has been enhanced. The ectd import functionality has been enhanced to retain the previously assigned leaf title when a delete operation does not provide a leaf title. The ectd import process has been enhanced to better handle erroneous ectd backbone files (index.xml, cc-regional.xml and stf.xml). The High LORENZ Life Sciences Group 6

7 enhancements include, but are not limited to: a) the format and version detection, b) invalid characters handling and c) import logging. DB New File Location for Files Opened in Native Application When opening files in native application, either from docubridge Explorer or Submission Workbench, and using client-side caching, the files open from a new location starting with docubridge 18.2: '%localappdata%\lorenz Life Sciences\docuBridge\~dbNativeTemp\'. Previously, the files were opened from: '%temp%\~dbnative\'. Table Addressed Issues Submission Workbench DB-9801 LLS Administrative Information: Legacy Grouping Data of US Grouped Submissions DB LLS Include Hyperlinks and Include Bookmarks Mode on Updated Content An issue with legacy grouping data of US grouped submissions being copied to new sequences, but not being visible in the Administrative Information section, has been resolved. If such legacy data created in docubridge versions 5.8.x/5.9.x, is detected, it is automatically removed from the database when the Administrative Information for a sequence is edited and changes are saved. Please note: There will be a problem with this solution if the rather unlikely scenario is encountered: A customer creates a US Grouped Submission in pre-2.2 docubridge ONE installation and then upgrades to docubridge ONE before publishing this Grouped Submission. In this case copying an application as a new sequence will clear the old grouping information; therefore, the customer will need to reconstruct the grouped submission using the current docubridge ONE functionality to be able to publish the grouped submission in docubridge ONE An issue with included Hyperlinks and Bookmarks not being properly removed from the database (and the Bookmarks Pane in the Submission Workbench) when replacing content in a LORENZ Life Sciences Group 7

8 subsequent sequence and using the Hyperlink and Bookmark mode Include has been resolved. DB Blank Pages displayed using Default View DB-9641 LLS Publishing of Referenced nodes in Inter-Sequence Scenario DB Text Selection and Search Results on Rotated Pages DB-9030 LLS Cross Application Referenced Files List Displayed Unsorted DB-7713 LLS Administrative Information History Attributes Display Code DB Content Catalog Pane Display DB Submission Workbench Display Freeze Issue DB Drag & Drop of Bookmarks An issue with blank pages being displayed in some PDF files when using the docubridge Default View in the Submission Workbench (i.e. the PDFIUM library) has been resolved. An issue causing XML leaves are not to be published when node references have been set across sequences has been resolved. An issue with full text search results not being properly highlighted when displaying a PDF with rotated pages has been resolved. An issue with the files and folders list not being displayed sorted in the browse dialog for a 'Cross Application Referenced File' has been resolved. An issue with historic values displaying the code instead of the proper display value in the administrative information section has been resolved. An issue with the display of the Content Catalog Pane causing an error has been resolved. An issue with the Submission Workbench display freezing when resizing the Submission Workbench window or when working with panes (e.g. pinning/unpinning) has been resolved on client computers running MS Windows 7. A similar issue with an error being thrown on client computers with Windows 10 has also been resolved. These issues were only encountered when the display setting for zooming was greater than 100% (e.g. 125% or 150%). An issue with dragging & dropping bookmarks for hyperlink creation not working if the Hyperlink Mode of the content file was not 'Use PDF Hyperlinks' and the Bookmark Mode was 'Use PDF Bookmarks' has been resolved. Table 3-5 LORENZ Life Sciences Group 8

9 3.2.2 Specification Support # DB-9810 LLS-20940, LLS-22242, LLS US 3.3 Grouped Submission Forms Replication An issue wherein not all applicable application forms were replicated from the master to the child submissions in US grouped submissions has been resolved. DB EU UUID Retrieved from Sequences not selected for Import DB EU UUID not Imported DB-9757 LLS EU UUID is not Imported if UUID Already Exists An issue with the European Union Application Identifier (UUID) being imported from sequences which are currently not selected in the import dialog for import has been resolved. The import logic has been refined so that the sequences which are marked for import are analyzed. An issue with the European Union Application Identifier (UUID) not being imported if the customimport-rules.xml was configured incorrectly to set a document type that was not defined in the attributes.xml or custom-attributes.txt file has been resolved. An issue with the European Application Identifier (UUID) not being imported if there was already a UUID stored in the database for the application has been resolved. When importing ectd sequences with an UUID, the UUID will always be imported. Note: In case there is the need to change the European Application Identifier for an existing application in docubridge, please contact LORENZ Support in cased needed. Table Other Items DB-9798 LLS-22184, LLS Installation error due to invalid LocalDB download URL An issue with new docubridge ONE installations failing due to a changed download URL for the required database files (LocalDB) from the Microsoft website has been resolved. The required database installation files will now be maintained by LORENZ. LORENZ Life Sciences Group 9

10 DB Suspended Import Jobs do not Resume An issue with resuming suspended Import Jobs failing has been resolved. DB-9774 LLS-21989, LLS Attributes not Displayed in Import Dialog An issue with the two attributes 'Version ' and 'Current version' not being displayed in the import dialog has been resolved. DB Performance Issue with docubridge links DB Handling of Cached Files An issue with the performance of docubridge links (e.g. a link from the infopanel job log to a specific node) has been resolved. An issue with files being copied to the local cache directory even though they already existed there has been resolved. Table Known Issues DB-9689 LLS Adobe Acrobat Crash when Opening a PDF in Native View a Second Time An issue has been identified with Adobe Acrobat crashing when opening the same PDF file in successive order via the 'Open in Native Application' functionality from within docubridge. LORENZ will report this bug to Adobe. Table 3-8 N/A LORENZ Life Sciences Group 10

11 LORENZ Life Sciences Group Internet: LORENZ Archiv-Systeme GmbH Eschborner Landstrasse Frankfurt/Main GERMANY Tel Fax LORENZ Life Sciences Ltd. No. 1 Farnham Road Guildford, Surrey GU2 4RG UNITED KINGDOM Tel Fax LORENZ Polska APC Instytut Sp. z o.o. ul Grójecka 22/24/4 Warsaw POLAND Tel Fax LORENZ International LLC 1515 Market Street, Suite 1200 Philadelphia, PA USA LORENZ Newbook Inc Derry Road East, Unit 39 Mississauga, Ontario, L5S 1V6 CANADA Tel LORENZ Fax Tel LORENZ Life Sciences India Pvt Ltd. Olympia Tech Park, Level -2, Altius No: 01, Sidco Industrial Estate Ekkatuthangal, Guindy Chennai INDIA Tel Fax Digital Media System Co., Ltd. Tsukiji No. 1 Nagaoka Building Tsukiji, Chuo-ku, Tokyo JAPAN Tel Fax

12 System Requirements Specification docubridge ONE 18.2 October 2018 LORENZ Life Sciences Group

13 System Requirements Specification docubridge ONE 18.2 Table of Contents 1. System Requirements Overview Hardware Requirements Software Requirements Use of Virtualized Environments Support Status Operating Systems Adobe Acrobat... 5

14 System Requirements Specification docubridge ONE System Requirements Overview 1.1 Hardware Requirements The hardware listed below is sized to ensure proper operation of docubridge ONE, leaving enough processing power to the system to satisfy the operation of other applications tasks. Component Computer, Processor Memory Comment A state of the art computer and processor that supports the requirements of the chosen Operating System is recommended. Depending on the chosen Operating System, we recommend using 4 GB or more of Memory. Disc Space docubridge ONE stores the data on the Workstation, we recommend having 500 MB or more free disc space. Display Configuration LORENZ recommends at least a single Monitor with a native resolution of 1920 x Dual-Monitor Environments are not required but the ability to run docubridge on one Monitor and another application on the second Monitor does add value to the user. Table Software Requirements The software listed below names the required items that need to be present in order to install and operate docubridge ONE. Component Operating System Comment A Microsoft Windows Workstation Operating System is required. For a complete list of Operating Systems and their current status please also refer to chapter 2.1. LORENZ suggests using the latest Windows Service Packs and updates available. Please Note: There are known issues with systems running with a custom scaling other than 100% for text and apps..net Framework Microsoft SQL LocalDB (Express) Database Content Viewing Microsoft s.net Framework version or higher is required. The docubridge ONE setup checks for the appropriate.net version and downloads and installs it if needed. The docubridge ONE setup checks for an appropriate Microsoft SQL LocalDB Database and downloads and installs it if needed. Possible Tools: LORENZ Life Sciences Group 3

15 System Requirements Specification docubridge ONE 18.2 Default View (Built-In) 1 [optional] Adobe Acrobat (Standard or Professional. See chapter 2.2) [optional] Adobe Reader 2 Internet Installation docubridge ONE requires Internet Access in order to activate the software and to purchase and use Publishing Tokens. The following browsers have been tested and are supported in this release. Even though a specific version of a browser is not listed, it still may work (especially for browsers with rapid release cycles such as Chrome and Firefox). Internet Explorer: 11 Edge: 42.0 Firefox: 62.0 Chrome: 69.0 To install docubridge ONE an administrator account is needed. Table Use of Virtualized Environments LORENZ supports Virtual Environments as transparent. In other words: we do expect the virtualization environment with an installed supported or certified operating system to perform identically when compared to the same operating system being installed into a physical environment. LORENZ would like to remind customers that there are certain techniques that can be applied to virtualized environments which may cause issues with the Product activation of docubridge: the hardware code for docubridge is calculated based upon a combination of characteristics of the system it is operated on: BIOS, CPU, Primary HDD, NIC MAC Address, and Operating System. Should too many of these identifiers be changed through the use of specific procedures, (e.g. when moving a virtualized environment to a different node) then the system will consider the activation invalid. 1 The Default content view uses the PDFium library. Copyright 2018 PDFium.org THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS "AS IS" AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE COPYRIGHT HOLDER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. 2 Please note that Adobe Reader provides only viewing functionalities for content in the Submission Workbench. LORENZ Life Sciences Group 4

16 System Requirements Specification docubridge ONE Support Status 2.1 Operating Systems Operating System Microsoft Windows 10 Microsoft Windows 7 SP1 Microsoft Windows 8, 8.1 Microsoft Windows 7 Status Certified Certified Supported Supported Table Adobe Acrobat Version Adobe Acrobat DC Continuous Track Adobe Acrobat DC Classic Track Adobe Acrobat XI Adobe Acrobat X Adobe Acrobat 9 Adobe Acrobat 8 Status Certified Certified Supported Supported Supported Not Recommended Table Please Note: Adobe Acrobat DC has a problem with its installation package that leads to viewing problems in docubridge. Please perform a repair installation of Adobe Acrobat DC after you have installed it the first time. The above listed version of Acrobat DC has been tested and is therefore certified for this release. Even though a specific version of Acrobat DC is not listed, it still may work (especially for Adobe Acrobat Continuous Track with rapid release cycles). LORENZ Life Sciences Group 5

17 LORENZ Life Sciences Group Internet: LORENZ Archiv-Systeme GmbH Eschborner Landstrasse Frankfurt/Main GERMANY Tel Fax LORENZ Life Sciences Ltd. No. 1 Farnham Road Guildford, Surrey GU2 4RG UNITED KINGDOM Tel Fax LORENZ Polska APC Instytut Sp. z o.o. ul Grójecka 22/24/4 Warsaw POLAND Tel Fax LORENZ International LLC 1515 Market Street, Suite 1200 Philadelphia, PA USA LORENZ Newbook Inc Derry Road East, Unit 39 Mississauga, Ontario, L5S 1V6 CANADA Tel LORENZ Fax Tel LORENZ Life Sciences India Pvt Ltd. Olympia Tech Park, Level -2, Altius No: 01, Sidco Industrial Estate Ekkatuthangal, Guindy Chennai INDIA Tel Fax Digital Media System Co., Ltd. Tsukiji No. 1 Nagaoka Building Tsukiji, Chuo-ku, Tokyo JAPAN Tel Fax