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Release Notes GLOBALvalidator 3.0 SP3 - Extedo

Release Notes GLOBALvalidator 3.0 SP3 - Extedo

Release Notes GLOBALvalidator 3.0 SP3 - Extedo

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CONFIDENTIAL - PROPRIETARYImpact low, detectability low, detected in version 2.0.00.11Issue 22962: (CAS-05567-RJ38) NeeS: Invalid links in ToC cause too many errors (rule 01.07)In the case that a ToC PDF file contained invalid hyperlinks (without a destination) EURSvalidator/<strong>GLOBALvalidator</strong>skipped all other hyperlinks in the file and reported too many rule violations for EUNeeS 2.1 and HR NeeS 2.1 rule 01.07.Impact medium, detectability medium, detected in version 2.0.00.11Issue 22967: (CAS-05592-0YXZ) PDFs with bookmarks to named destinations are skippedIn some cases EURSvalidator/<strong>GLOBALvalidator</strong> could not resolve bookmarks to named destinations andskipped the affected documents. The problem affected the following rules:EU and HR eCTD v3.1: 16.BP03, 16.BP05, 16.BP06, 16.BP10 and 16.BP11 EU and HR NeeS v2.1:03.BP03, 03.BP04, 03.BP08Impact medium, detectability high, detected in version 2.0.00.11Issue 23083: EU eCTD v3.1 Rule 16.03 does not consider exceptionsAccording to EU eCTD v3.1 Rule 16.03 PDF files must not have any security restrictions. However, thesections m3/33-lit-ref, m4/43-lit-ref and m5/54-lit-ref are exempt from this rule. EURSvalidator/<strong>GLOBALvalidator</strong>did not consider this exception. The same applied to EU NeeS v2.1 rule 0<strong>3.0</strong>3 andthe HR counterparts.Impact medium, detectability high, detected in version 2.0.00.11Issue 23658: EU NeeS v2.1 rule 01.05 ignores missing links to module ToCsThe EU NeeS v2.1 rule 01.05 did not check if the main ToC contains a link to each existing module ToC.A new fail message has been added: fail-01.05.04: Module TOCs are used, but the Main CTD TOC doesnot contain hyperlinks to all module TOCs. Missing hyperlinks: {0}. The issue also affects HR NeeS v2.1.Impact medium, detectability medium, detected in version <strong>3.0</strong>.0.0005Issue 23855: (CAS-06205-512Y) Hyperlinks with target outside of the EU-NeeS 2.1 and HR-NeeS 2.1are not recognized (rule 03.BP02)The rule did not recognize a hyperlink with a target outside of the NeeS in the following case: The sequencefolder name in the hyperlink reference equals the current sequence folder name but the parentfolder name is different. E.g. the current sequence is located in abc\0000 and the hyperlink points to a filein ..\..\def\0000.Impact medium, detectability high, detected in version 2.0.00.11Issue 24031: Report rendering fails when validating EU DTD 1.3 submission with EU 3.1 rulesWhen an EU submission based on DTD 1.3 was validated using the EU-eCTD v 3.1 (DTD 1.4) validationset the creation of the report failed with an exception message. HR-eCTD v3.1 (DTD 1.4) was also affected.Impact high, detectability high, detected in version <strong>3.0</strong>.0.00082.3 Validation Set SummaryThe following table provides a summary of the available validation sets (x) in the free version (EURSvalidator)and the licensed version of <strong>GLOBALvalidator</strong>. The last column indicates whether the validation sethas been modified in this version because of bug fixes or enhancements.Validation Set Name EURSvalidator <strong>GLOBALvalidator</strong> Modified in this versionFDA-eCTD v1.0 (DTD 2.01) x x -Template version: 4.0 Template release date: 16-Apr-2012 Page 6 of 27

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