Release Notes GLOBALvalidator 3.0 SP3 - Extedo

CONFIDENTIAL - PROPRIETARYAutoselect has been updated to select this new validation set for EU M1 DTD 1.4.This feature is available in both versions (EURSvalidator + GLOBALvalidator).Feature 25231: GCC-eCTD 1.0 Validation SetThe Gulf Countries published a new GCC eCTD validation set which is now supported by GV.Autoselect has been extended to select this new validation set for GCC M1 DTD 1.0.This feature requires a license and is not available in the free version (EURSvalidator).Feature 25232: GCC: KSA-NeeS 1.0 Validation SetThe Kingdom of Saudi Arabia published a new KSA-NeeS validation set which is now supported by GV.Autoselect has been extended to select this new validation set for KSA-NeeS (see also feature 25241).This feature requires a license and is not available in the free version (EURSvalidator).Feature 25233: EU-NeeS 3.0 Validation SetEMA published a new EU NeeS validation set which is now supported by EV/GV.Autoselect has been extended to select this new validation set for EU-NeeS (see also feature 25241).This feature is available in both versions (EURSvalidator + GLOBALvalidator).Feature 25241: Enhance autoselector to detect NeeS and vNeeS submissionsAutoselect has been extended to find also a NeeS-Submission: EU-NeeS, HR-NeeS, KSA-NeeS.The NeeS-Submission must follow these requirements to be detected:There must be the file ctd-toc.pdf stored in the submission folder.There must be a folder /m1/xx/10-cover (xx must be eu or gc) with the correct named cover letterdocument (CC-cover-VAR.pdf).Depending on the region code in folder path (xx is eu or gc) and the country code in cover letter file name(CC) the correct validation set (EU-NeeS 3.0, HR-NeeS 2.1, KSA-NeeS 1.0) can be selected for the submission.Examples: /m1/eu/10-cover/de-cover.pdf EU NeeS 3.0 /m1/eu/10-cover/hr-cover.pdf HR NeeS 2.1 /m1/eu/10-cover/common-cover.pdf EU NeeS 3.0 /m1/gc/10-cover/common-cover.pdf KSA NeeS 1.0 /m1/gc/10-cover/sa-cover.pdf KSA NeeS 1.05.2 Fixed IssuesIssue 22825: (CAS-05447-XFY9) eCTD v3.1 criterion 16.BP08 / NeeS v2.1 Criterion 03.BP06 incorrectEURSvalidator doesn’t properly check for eCTD v3.1 criterion 16.BP8/NeeS v2.1 Criterion 3.BP6 [PDFDocument Properties for the Inital View are set for "Page Layout = Default" and "Magnification = Default"].It doesn’t detect an error when pdfs have incorrect Initial View settings.Impact medium, detectability medium, detected in version 2.0.00.08Issue 24367: FDA 2.1 rule 5005 allows some non-standard fontsThe FDA 2.1 rule 5005 identifies some non-standard fonts as standard fonts, e.g. font names starting withbut not equal to "Arial". A more exact check is required.Impact medium, detectability medium, detected in version 3.0.00.16Template version: 4.0 Template release date: 16-Apr-2012 Page 13 of 27