Resolved Issues: Ennov InSight Validator 5.1

The following table provides details of the enhancements and issues resolved in Ennov InSight Validator 5.1:

Issues are listed in descending order by their tracking numbers. Customer incident numbers that were recorded when the issues were reported are included in brackets [#####] following the tracking number.


Issue	Description
794	US region: For US submissions, the option to specify the file extension for validation has been removed. It will now not be possible to validate US submissions against user defined file extensions.
793; [00054368]	US region: Ennov InSight Validator failed submissions under the criterion 1306 when there was a difference in the file path and xml xlink:href letter case. This issue is resolved.
790; [00052050]	Ennov InSight Validator froze when validating PDF documents which contained web links with non-printable characters. This issue is resolved.
788; [00051337]	AU region: Ennov InSight Validator failed submissions under the criterion 6.12: "Hyperlinks to other external destinations (not web or email) are not allowed". This issue is resolved.
787	For US region: US FDA submissions with a large number of sequences being validated over a network location were taking considerably longer to complete when compared with local file system validation. Subject to network related factors, performance has been improved.
786; [00052239]	When recalculating checksums, the values in the regional.xml file inadvertently changed. This issue is resolved.
784; [00051673]	GCC region (NeeS): Ennov InSight Validator failed submissions that had correct folder structure and folder names under the criteria 3.7 and 3.8. This issue is resolved.
783; [00051156]	EU region: Ennov InSight Validator failed submissions under the criterion 11.10 when leafs replaced in section 1.2 had the country attribute "emea" instead of "ema". According to the Harmonised Technical Guidance for eCTD Submissions in the EU (v4.0) guidelines, leafs with the country attribute 'ema' or 'emea' are valid. This issue is resolved.
782; [00035215]	US region: For submissions with PDF security enabled form 3676, Ennov InSight Validator failed these submissions under the criteria 5040 and 5020. According to FDA guidelines, PDF security enabled form 3676 must be exempt under the criteria 5040 and 5020. This issue is resolved.
769	ZA region: Some element names on the Submission pane were followed by unexpected characters, such as question marks or equal signs, instead of a colon. This issue is resolved.
767; [00048324]	CA region: Ennov InSight Validator failed submissions that had correct sequence descriptions under the criterion F09. This issue is resolved.
753; [00046504]	US region: Submissions without STF files in sections 5.3.6 and 5.3.7 are considered valid according to the FDA guidelines and therefore such submissions are now passed by Ennov InSight Validator.
744	Canada: Validation: Criterion C03 did not check the operation status for an initial submission and displayed an uninformative error description. This issue is resolved.
729	HC region: For the criterion G16, Ennov InSight Validator validated submissions for the modules m2-m5 while the validation as a prerequisite is limited to m1 module according to criterion G16. This issue has been resolved.
725	HC region: Ennov InSight Validator failed submissions under the criteria A02 and C06 when they complied with the requirements of these criteria. This issue is resolved.
722	Validation number inaccuracies in the Validation window have been fixed in this release.
683	EU NeeS: Ennov InSight Validator failed submissions under the criterion 1.4 - "If Module TOC files are present, each and every module folder (/m1, /m2, etc.) contains the correctly named Module TOC file", although no module TOCs were present in the submissions. This issue is resolved.
679; [00042852]	Ennov InSight Validator should display a warning when both an STF and a Node Extension are used in a Health Canada submission, when only one or the other is permitted. This issue is resolved.
675	The Errors Only report displayed only high severity errors, when it should display all errors. This issue is resolved
659	US region: The error message displayed when a submission failed under the criterion 1130 was incorrect. This issue has been resolved.
643	Review: When the Ennov InSight Validator window was changed to a size smaller than the full size, clicking on the Recalculate button reset the window to full size instead of retaining the previously set size. This issue is resolved.
606	Unnecessary validation criteria for a US 2.01 submission appeared on the Validation Results tab when a US 3.3 submission was opened. This issue is resolved.
594	After modifying the report location path under User Preferences, if you selected another tab and then clicked OK, the changes made to the report location were not saved. This issue is resolved.
593	Ennov InSight Validator could not open and validate submissions that included an invalid DTD version attribute in a regional XML file. This issue is resolved.
577	US region, DTD 3.3 version: The submission information under Selected Submission Details was displayed in a table instead of in a list. This issue is resolved.
570; [00039927, 00051403, 00052050]	Slow performance issues were evident when trying to load and validate large submissions when using a network connection between distinct geographical locations. This issue has been resolved.
562	After making changes in the Preferences window and clicking on "No" in the confirmation message, the "Reset" and "Reset All" options failed to restore the original values. This issue is resolved.
538	EU NeeS: Validation did not report a failure when Bookmarks present in the main CTD TOC file were not functioning correctly. This issue is resolved.
517	Croatia now follows the EU regional specification module as a result of its accession to EU. Therefore, Ennov InSight Validator no longer supports the validation of Croatia submissions.