Clarification of Behavior

This table describes functionality that has been reported as an issue, but is in fact working as designed. The items are listed in descending order by their tracking numbers.

Issue Description
1568 When using Google Chrome or Microsoft Edge browsers, it is recommended that the language in the browser settings be set to an option other than English for annotation information to show in a PDF document. Selecting English (United States) - en-US or English (United Kingdom) - en-UK or other options (except English), enables the annotation information to be shown in a PDF document.
1484, 1323;

[00063169, 00048443]

The STF.xml file was not formatted according to the Style Sheet when using ich0ste0stylesheet-2-2a.xsl (May 2007) instead of version 2-3 (June 2017). When using Microsoft Internet Explorer 8 and higher versions, Compatibility View settings should be enabled.
1376 To conform with the US FDA DTD versions 2.01 and 3.3, the FDA Regional and Administrative Information folder is no longer displayed in the M1 module folder in the submission table of contents (TOC). Please note that the cache must be recreated for US applications to avoid the duplication of certain M1 folders. This is applicable to Calyx RIM Viewing 5.4 CHF 4 and later versions.
1273;

[00045066, 00049367]

The built-in PDF viewer does not display PDF documents that include XFA dynamic forms. As a workaround, download the document and open it using an external PDF viewer.
1158;

[00039488]

If the Internet Explorer zoom setting is not 100%, the components on the Calyx RIM Viewing application may appear out of place. It is recommended to always set the Internet Explorer zoom setting to 100%.
1151 The Form FDA 356h and Form FDA 1571 section/document will not be shown under the TOC for FDA 3.3 submissions. The document link will be shown under Administrative Information.

Submission Navigator and Metadata Search: For FDA 3.3 submission, the Submission ID value will be displayed under the Related Sequence column as the Submission ID in FDA v3.3 DTD is equivalent to the Related Sequence in FDA v2.01 DTD.

1046, 1132;

[00036774, 00038677]

A search criteria that includes only the user group values will not be saved, as the user group is used only for filtering the values of other fields in Navigator. However, the value of the user groups in combination with values of other fields can be used to save the criteria and works as expected.
1089 In a Calyx RIM Viewing environment with 64-bit Java and 64-bit Internet Explorer, documents selected for viewing show in an external window and not within the Calyx RIM Viewing document viewer for users of all roles except the Restricted Reviewer. Ideally, the documents must show in the document viewer, as in the case of 32-bit Internet Explorer. For the Restricted Reviewer role, 64-bit Internet Explorer must be used to access Viewing for documents to open in the document viewer.
915 After updating user credentials for an Electronic Document Management System (EDMS) that has been configured as a repository in Calyx RIM Viewing, the same changes must be made within Calyx RIM Viewing.
Note: After changes to EDMS credentials, you can access the EDMS using existing credentials in Calyx RIM Viewing for a specified period determined by your EDMS session timeout value. When this period has elapsed, you will be prompted to update the EDMS password in Calyx RIM Viewing.

See the topic: Modifying Repositories

299 When a PDF is opened in an external window, the PDF is copied to the local system. When clicking a link to another PDF, the system message could not open destination file appears. Because the "source PDF" is not in the browser window, no request is sent to the server to fetch the destination document.
TTP 10904 When a Word document is selected in a TOC, it opens in the Word application instead of in the Document Viewer. This issue is identified on Windows 7 with Microsoft Office 2007 and Microsoft Office 2010.
A workaround is provided in these Microsoft knowledge base articles:
N/A In Calyx RIM Viewing 5.5.8, if the ldap-map.xml file is configured before the user groups are created, the permissions for the user groups created will be applied only after the user logs out.
N/A After migrating cache from Calyx RIM Viewing 5.2 CHF 4 to Calyx RIM Viewing 5.5 for applications in SharePoint repository, if the error The prefix "ie" for element "ie:menuitem" appears, cache must be recreated.
N/A Submission Status:
  • If an application is registered with a status such as Planned when the value of submissionstatuslist attribute in the submissionstatus.xml file is "true", and then the value of the submissionstatuslist attribute is changed to "false", the Submission Status value will be blank in the Edit Application window. The Submission Status drop-down will be blank by default with Inactive as the only option available. If the value of the submissionstatuslist attribute is changed to "true" again, the Submission Status will display the latest status value that was set when the submissionstatuslist attribute was "true".
  • If an application is registered with a blank status when the value of submissionstatuslist attribute in the submissionstatus.xml file is "false", and then the value of the submissionstatuslist attribute is changed to "true", the Submission Status value will be blank in the Edit Application window. However, the Submission Status drop-down will list all of the options.