﻿<?xml version="1.0" encoding="utf-8"?>
<?xml-stylesheet type="text/xsl" href="util/validationreport.xsl"?>
<validationreport>
	<summaries>
		<summary id="application-name" description="Application Name"></summary>
		<summary id="location" description="Location"></summary>
		<summary id="sequence-number" description="Sequence Number"></summary>
		<summary id="regional-backbone-version" description="Region/DTD"></summary>
		<summary id="validation-profile" description="Validation Profile"></summary>
		<summary id="selected-modules" description="Selected Modules"></summary>
		<summary id="result" description="Result"></summary>
	</summaries>
	<validations id="0" description="WHOPQT Criteria">
		<validation id="1" description="A - Technical Files">
			<validation id="A.01" description="The specified filename is used for the WHO-PQT M1 DTD" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">UtilFilesInvalidPath</validator>
			</validation>
			<validation id="A.02" description="The file is placed in the correct folder for the WHO-PQT M1 DTD" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">UtilFilesInvalidPath</validator>
			</validation>
			<validation id="A.03" description="A currently acceptable version of the WHO-PQT M1 DTD is used (checksum matches the published value)" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">DtdChecksumFailed</validator>
			</validation>
			<validation id="A.04" description="The version number of the WHO-PQT M1 DTD used in the sequence being tested is higher than or equal to the version of the DTD used in the sequence numerically preceding the incoming sequence in the eCTD lifecycle. " severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">RegionalDtdVersionPreceding</validator>
			</validation>
			<validation id="A.05" description="The version number of the WHO-PQT M1 DTD used in the sequence being tested is lower than or equal to the version of the DTD used in the sequence numerically succeeding the incoming sequence in the eCTD lifecycle." severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">RegionalDtdVersionSucceeding</validator>
			</validation>
			<validation id="A.06" description="The specified filename is used for the WHO-PQT M1 leaf MOD file" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">UtilFilesInvalidPath</validator>
			</validation>
			<validation id="A.07" description="The file WHO-PQT M1 leaf MOD file is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">UtilFilesInvalidPath</validator>
			</validation>
			<validation id="A.08" description="The checksum for the whopqt-leaf.mod file used must match the published checksum for the who-leaf.mod file associated with the DTD used for the sequence" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">DtdChecksumFailed</validator>
			</validation>
			<validation id="A.09" description="The specified filename is used for the WHO-PQT M1 envelope MOD file" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">UtilFilesInvalidPath</validator>
			</validation>
			<validation id="A.10" description="The WHO-PQT M1 envelope MOD file is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">UtilFilesInvalidPath</validator>
			</validation>
			<validation id="A.11" description="The checksum for the whopqt-envelope.mod file used must match the published checksum for the whopqt-envelope.mod file associated with the DTD used for the sequence" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">DtdChecksumFailed</validator>
			</validation>
			<validation id="A.12" description="The specified filename for the ICH DTD is used" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">UtilFilesInvalidPath</validator>
			</validation>
			<validation id="A.13" description="The ICH DTD file is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">UtilFilesInvalidPath</validator>
			</validation>
			<validation id="A.14" description="A currently acceptable version of the ICH DTD is used (checksum matches the published value)" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">IchChecksumFailed</validator>
			</validation>
			<validation id="A.15" description="The version number of the ICH DTD used in the sequence being tested is higher than or equal to the version of the DTD used in the sequence numerically preceding the incoming sequence in the eCTD lifecycle. " severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">IchDtdVersionPreceding</validator>
			</validation>
			<validation id="A.16" description="The version number of the ICH DTD used in the sequence being tested is lower than or equal to the version of the DTD used in the sequence numerically succeeding the incoming sequence in the eCTD lifecycle. " severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">IchDtdVersionSucceeding</validator>
			</validation>
			<validation id="A.17" description="The Index MD5 file is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">SubmissionChecksum.Failed</validator>
			</validation>
			<validation id="A.18" description="The file Index MD5 file is named correctly" severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">SubmissionChecksumFileName.Failed</validator>
			</validation>
			<validation id="A.19" description="The regenerated checksum for the index.xml matches the value in the file index-md5.txt." severity="Error">
				<validator type="log" dependingOption="whopqt-10-1">Index.Checksum.Failed</validator>
			</validation>
		</validation>
		<validation id="2" description="B - XML Backbone Files">
			<validation id="B.01" description="The index.xml is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="whopqt-10-2">Backbone.NotExist</validator>
				<validator type="log" dependingOption="whopqt-10-2">Regional.Backbone.Multiple</validator>
			</validation>
			<validation id="B.02" description="The index.xml file is named correctly" severity="Error">
				<validator type="log" dependingOption="whopqt-10-2">EU_CH_GC_AUBackbone.NotExist</validator>
			</validation>
			<validation id="B.03" description="The index.xml file is well formed" severity="Error">
				<validator type="log" dependingOption="whopqt-10-2">Xml</validator>
			</validation>
			<validation id="B.04" description="The index.xml file is valid" severity="Error">
				<validator type="log" dependingOption="whopqt-10-2">Xml</validator>
			</validation>
			<validation id="B.05" description="The reference to the DTD in index.xml is directed to the DTD provided in the util folder." severity="Error">
				<validator type="log" dependingOption="whopqt-10-2">InvalidSchemaOrDtdLocation</validator>
			</validation>
			<validation id="B.06" description="The whopqt-regional.xml file is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="whopqt-10-2">Backbone.NotExist</validator>
				<validator type="log" dependingOption="whopqt-10-2">Regional.Backbone.Multiple</validator>
			</validation>
			<validation id="B.07" description="The whopqt-regional.xml file is named correctly" severity="Error">
				<validator type="log" dependingOption="whopqt-10-2">EU_CH_GC_AUBackbone.NotExist</validator>
			</validation>
			<validation id="B.08" description="The whopqt-regional.xml file is well formed" severity="Error">
				<validator type="log" dependingOption="whopqt-10-2">Xml</validator>
			</validation>
			<validation id="B.09" description="The whopqt-regional.xml file is valid" severity="Error">
				<validator type="log" dependingOption="whopqt-10-2">Xml</validator>
			</validation>
			<validation id="B.10" description="The reference to the DTD in whopqt-regional.xml is directed to the DTD within the util-folder." severity="Error">
				<validator type="log" dependingOption="whopqt-10-2">InvalidSchemaOrDtdLocation</validator>
			</validation>
		</validation>
		<validation id="3" description="C - XML Elements">
			<validation id="C.01" description="The leaf attribute 'checksum-type' has a value of md5 or MD5" severity="Error">
				<validator type="log" dependingOption="whopqt-10-3">ChecksumType.Incorrect</validator>
			</validation>
			<validation id="C.02" description="The regenerated checksum for each file matches the value in the leaf attribute 'checksum'" severity="Error">
				<validator type="log" dependingOption="whopqt-10-3">Checksum.Failed</validator>
			</validation>
			<validation id="C.03" description="For every leaf the 'title' attribute is not empty" severity="Error">
				<validator type="log" dependingOption="whopqt-10-3">Leaf.Title.Empty</validator>
				<validator type="log" dependingOption="whopqt-10-3">NodeExtension.Title.Empty</validator>
			</validation>
			<validation id="C.04" description="All leaves with an operation attribute value of new, replace or append must have a value for the cross reference (xlink:href) " severity="Error">
				<validator type="log" dependingOption="whopqt-10-3">BlankHref</validator>
			</validation>
			<validation id="C.05" description="All leaves with an operation attribute value of delete must have no value for the cross reference (xlink:href)" severity="Error">
				<validator type="log" dependingOption="whopqt-10-3">DeletedLeaf.Href.NotBlank</validator>
			</validation>
			<validation id="C.06" description="The file referenced by the cross reference (xlink:href) must exist in the same or a previously submitted sequence within the same eCTD application" severity="Error">
				<validator type="log" dependingOption="whopqt-10-3">HrefPointToFile.NotExist</validator>
			</validation>
			<validation id="C.07" description="All leaves with an operation attribute value of replace, delete or append must have a value for modified-file" severity="Error">
				<validator type="log" dependingOption="whopqt-10-3">ModifiedFile.Unverifiable</validator>
			</validation>
			<validation id="C.08" description="All leaves with an operation attribute value of new must have no value for modified-file" severity="Error">
				<validator type="log" dependingOption="whopqt-10-3">ModifiedFileExist</validator>
			</validation>
			<validation id="C.09" description="The leaf referenced by the modified file must exist in a previously submitted sequence within the same eCTD application." severity="Error">
				<validator type="log" dependingOption="whopqt-10-3">ModifiedFileNotFound</validator>
			</validation>
			<validation id="C.10" description="For all leaves (except leaves within node extensions  and leaves in module 3.2.A) with an operation attribute value of replace, delete or append, the modified file must be present in the same CTD section of the dossier. Note: Using the operation attribute 'delete' to remove content placed in m1-additional-data  is exempt from this rule." severity="Error">
				<validator type="log" dependingOption="whopqt-10-3">ModifiedFile.NotInSameSection</validator>
			</validation>
			<validation id="C.11" description="Two leaf elements should not have the same leaf ID. " severity="Error">
				<validator type="log" dependingOption="whopqt-10-3">SameLeafId</validator>
			</validation>
			<validation id="C.12" description="For all leaves with an operation attribute value of replace, delete or append the modified file must not have been replaced or deleted by any other leaf element in any sequence including the current one." severity="Error">
				<validator type="log" dependingOption="whopqt-10-3">EU.InvalidLifeCycleOperation</validator>
			</validation>
			<validation id="C.13" description="For all leaves within node extensions or module 3.2.A with an operation attribute value of replace, delete or append, the modified file should be present in the same node extension or attribute-defined section. " severity="Warning">
				<validator type="log" dependingOption="whopqt-10-3">ModifiedFile.NotInSameNodeExtension</validator>
				<validator type="log" dependingOption="whopqt-10-3">ModifiedFile.NotInSameNodeExtensionOrSection</validator>
			</validation>
			<validation id="C.14" description="ICH attributes must not contain leading or trailing spaces, nor start or end with hyphens. " severity="Warning">
				<validator type="log" dependingOption="whopqt-10-3">ICH.Attributes</validator>
			</validation>
		</validation>
		<validation id="4" description="D - PDF Details">
			<validation id="D.01" description="No PDF has been created and saved as version 1.3 or earlier " severity="Error">
				<validator type="log" dependingOption="whopqt-10-4">Pdf.UnsupportedPdfVersion</validator>
			</validation>
			<validation id="D.02" description="There is no security setting to open any individual file " severity="Error">
				<validator type="log" dependingOption="whopqt-10-4">PdfSecurity</validator>
			</validation>
			<validation id="D.03" description="There are no further security settings applied to any individual file (except for files in Modules 1.0, 1.2.1, 3.3, 4.3 and 5.4)" severity="Error">
				<validator type="log" dependingOption="whopqt-10-4">PdfSecurity</validator>
			</validation>
			<validation id="D.04" description="
            Individual files in section 1.0 and 1.2.1 have no security settings except for the following:
            Changing the document
            Document assembly
            Page extraction
            Commenting
            Creation of template pages. " severity="Error">
				<validator type="log" dependingOption="whopqt-10-4">DeniedPermission</validator>
			</validation>
			<validation id="D.05" description="The submission does not contain corrupted files" severity="Error">
				<validator type="log" dependingOption="whopqt-10-4">Pdf.Failed</validator>
			</validation>
			<validation id="D.06" description="Files have been created and saved as PDF 1.4, 1.5, 1.6, or PDF 1.7" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-4">Pdf.UnsupportedPdfVersion</validator>
			</validation>
			<validation id="D.07" description="Hyperlinks and bookmarks within documents, or between documents within the same sequence, have a valid target." severity="Warning">
				<validator type="log" dependingOption="whopqt-10-4">BrokenLinkInPdf</validator>
				<validator type="log" dependingOption="whopqt-10-4">BookmarkBrokenLinkInPdf</validator>
			</validation>
			<validation id="D.08" description="Hyperlinks and bookmarks to destinations in a different sequence in the same eCTD dossier have a valid target." severity="Warning">
				<validator type="log" dependingOption="whopqt-10-4">BrokenLinkInPdf</validator>
				<validator type="log" dependingOption="whopqt-10-4">BookmarkBrokenLinkInPdf</validator>
			</validation>
			<validation id="D.09" description="All hyperlinks and bookmarks are set to 'inherit zoom'" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-4">Pdf.InvalidMagnification</validator>
				<validator type="log" dependingOption="whopqt-10-4">Bookmark.Pdf.InvalidMagnification</validator>
			</validation>
			<validation id="D.10" description="PDFs except the files from section 1.0 and 1.2.1 must have 'Fast Web View' active" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-4">PdfFastWebAccess</validator>
			</validation>
			<validation id="D.11" description="PDF Document Properties for the Initial View are set for 'Page Layout = Default' and 'Magnification = Default'" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-4">Pdf.InvalidInitialView</validator>
			</validation>
			<validation id="D.12" description="All PDF hyperlinks and bookmarks are relative" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-4">AbsolutePathInPdf</validator>
				<validator type="log" dependingOption="whopqt-10-4">AbsolutePathBookmarkInPdf</validator>
			</validation>
			<validation id="D.13" description="The bookmarks pane should be visible if bookmarks are included within a PDF document " severity="Warning">
				<validator type="log" dependingOption="whopqt-10-4">Pdf.InvalidInitialView.Bookmark</validator>
			</validation>
			<validation id="D.14" description="The bookmarks pane should not be visible if there are no bookmarks included within a PDF document " severity="Warning">
				<validator type="log" dependingOption="whopqt-10-4">InvalidPageModeWhenNoBookmark</validator>
			</validation>
			<validation id="D.15" description="All hyperlinks and bookmarks between two PDFs must be configured as specified in ISO 32000-1:2008" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-4">PdfBackslash</validator>
				<validator type="log" dependingOption="whopqt-10-4">PdfBackslashBookmark</validator>
			</validation>
		</validation>
		<validation id="5" description="E - WHOPQT Envelope">
			<validation id="E.01" description="The UUID is well formed according to ISO/IEC 11578:1996 and ITU-T Rec X.667 | ISO/IEC 9834-8:2005" severity="Error">
				<validator type="log" dependingOption="whopqt-10-5">WHO.InvalidIdentifier</validator>
			</validation>
			<validation id="E.02" description="The UUID of a sequence must be identical to the one in the previous sequence." severity="Error">
				<validator type="log" dependingOption="whopqt-10-5">Identifier.Inconsistency</validator>
			</validation>
			<validation id="E.03" description="If the submission unit type is ‘initial’ or ‘reformat' then the related-sequence attribute must have a value equal to the current sequence." severity="Error">
				<validator type="log" dependingOption="whopqt-10-5">WHO.SubmissionUnitMustHaveRelatedSequence</validator>
			</validation>
			<validation id="E.04" description="If the submission unit type is not equal to ‘initial’ or ‘reformat' then the entry for related sequence must not be equal to the value for the current sequence." severity="Error">
				<validator type="log" dependingOption="whopqt-10-5">WHO.SubmissionUnitMustNotHaveRelatedSequence</validator>
			</validation>
			<validation id="E.05" description="Envelope Attributes: data is provided for all mandatory envelope fields and should be in the correct format, according to the requirements of FPP, FVP, APIPQ or APIMF." severity="Error">
				<validator type="log" dependingOption="whopqt-10-5">MandatoryEnvelopeFields.Empty</validator>
				<validator type="log" dependingOption="whopqt-10-5">MandatoryEnvelopeFields.Missing</validator>
				<validator type="log" dependingOption="whopqt-10-5">MandatoryEnvelopeFields.Duplicated</validator>
				<validator type="log" dependingOption="whopqt-10-5">MandatoryEnvelopeFields.WrongParent</validator>
				<validator type="log" dependingOption="whopqt-10-5">MandatoryEnvelopeFields.WrongFormatCaseId</validator>
			</validation>
			<validation id="E.06" description="The sequence folder name is a 4 digit number" severity="Error">
				<validator type="log" dependingOption="whopqt-10-5">SequenceNumberCharacters</validator>
			</validation>
			<validation id="E.07" description="The sequence number (folder name) has not already been used " severity="Error">
				<validator type="log" dependingOption="whopqt-10-5">SameSequenceNumber</validator>
			</validation>
			<validation id="E.08" description="The sequence folder name matches the sequence number in the WHOPTQ envelope in whopqt-regional.xml " severity="Error">
				<validator type="log" dependingOption="whopqt-10-5">SequenceNumberNotMatch</validator>
			</validation>
		</validation>
		<validation id="6" description="F - Files and Folders">
			<validation id="F.01" description="All the lowest level heading elements in the XML (including node-extensions) included in the submission contain at least one leaf " severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">FolderEmpty</validator>
			</validation>
			<validation id="F.02" description="Mandatory Files are provided: cover letter (mandatory for all application types)" severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">File.CoverLetter.NotFound</validator>
			</validation>
			<validation id="F.03" description="For submission unit type 'initial' and 'reformat' all required documents for the submitted application type are provided. " severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">RequiredFile.NotExist</validator>
				<validator type="log" dependingOption="whopqt-10-6">ExcludedFile.Exist</validator>
				<validator type="log" dependingOption="whopqt-10-6">PossibleFile.NotExist</validator>
			</validation>
			<validation id="F.04" description="APIMF: 2.3.S and 3.2.S: file names for specific sections should contain the correct prefix" severity="Information">
				<validator type="log" dependingOption="whopqt-10-6">AdditionalTemplateFileNaming</validator>
			</validation>
			<validation id="F.05" description="APIMF: 3.2.S: folder names for specific sections should contain the correct prefix" severity="Information">
				<validator type="log" dependingOption="whopqt-10-6">AdditionalTemplateFolderNaming</validator>
			</validation>
			<validation id="F.06" description="APIMF: 2.3.S and 3.2.S attributes of specific sections should contain op or rp as prefix" severity="Information">
				<validator type="log" dependingOption="whopqt-10-6">AdditionalTemplateSectionAtrribute</validator>
			</validation>
			<validation id="F.07" description="The files provided in the folders for Module 1 are in acceptable formats" severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">FileType.Invalid</validator>
			</validation>
			<validation id="F.08" description="The files provided in the folders for Module 2-5 are in acceptable formats" severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">FileType.Invalid</validator>
			</validation>
			<validation id="F.09" description="Total file folder path length must not exceed 180 characters" severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">LongPath</validator>
			</validation>
			<validation id="F.10" description="File names, including the extension, must not exceed 64 characters" severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">LongFileName</validator>
			</validation>
			<validation id="F.11" description="Folder names must not exceed 64 characters" severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">LongFileName</validator>
			</validation>
			<validation id="F.12" description="Only valid characters are used in file names" severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">Path.Invalid</validator>
			</validation>
			<validation id="F.13" description="Only valid characters are used in folder names" severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">Path.Invalid</validator>
			</validation>
			<validation id="F.14" description="There are no unreferenced files in M1, M2, M3, M4 and M5 folders" severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">M1Folder.RedundantFiles</validator>
				<validator type="log" dependingOption="whopqt-10-6">SubmissionFolder.RedundantFiles</validator>
				<validator type="log" dependingOption="whopqt-10-6">File.Extra</validator>
			</validation>
			<validation id="F.15" description="The only files in the sequence folder (/XXXX/…) are the index.xml and index-md5.txt" severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">M1Folder.RedundantFiles</validator>
				<validator type="log" dependingOption="whopqt-10-6">SubmissionFolder.RedundantFiles</validator>
				<validator type="log" dependingOption="whopqt-10-6">File.Extra</validator>
			</validation>
			<validation id="F.16" description="There are no empty folders" severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">EmptyFolder</validator>
			</validation>
			<validation id="F.17" description="Individual files do not exceed 500 MB in size" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-6">File.Size</validator>
			</validation>
			<validation id="F.18" description="The recommended folder structure and folder names in the ICH eCTD Specification and WHOPQT Module 1 eCTD Specification are used" severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">NamingConvention.Inconsistent</validator>
				<validator type="log" dependingOption="whopqt-10-6">M1.NamingConvention.NotMatch</validator>
			</validation>
			<validation id="F.19" description="The recommended file names from the ICH eCTD Specification and WHOPQT Module 1 eCTD Specification are used for all files." severity="Error">
				<validator type="log" dependingOption="whopqt-10-6">NamingConvention.Inconsistent</validator>
				<validator type="log" dependingOption="whopqt-10-6">M1.NamingConvention.NotMatch</validator>
			</validation>
		</validation>
		<validation id="7" description="G - Valid Values">
			<validation id="G.01" description="The Application Type attribute value is valid ." severity="Error">
				<validator type="log" dependingOption="whopqt-10-7">Envelope.ApplicationType</validator>
			</validation>
			<validation id="G.02" description="The Application Sub Type attribute value is valid." severity="Error">
				<validator type="log" dependingOption="whopqt-10-7">Envelope.ApplicationSubType</validator>
			</validation>
			<validation id="G.03" description="The Product Type attribute value is valid." severity="Error">
				<validator type="log" dependingOption="whopqt-10-7">Envelope.ProductType</validator>
			</validation>
			<validation id="G.04" description="The Product Sub Type attribute value is valid." severity="Error">
				<validator type="log" dependingOption="whopqt-10-7">Envelope.ProductSubType</validator>
			</validation>
			<validation id="G.05" description="The Submission Unit Type attribute value is valid." severity="Error">
				<validator type="log" dependingOption="whopqt-10-7">Envelope.SubmissionUnitType</validator>
			</validation>
			<validation id="G.06" description="Only specified combination for Product type, Application type and Application sub-type are valid." severity="Error">
				<validator type="log" dependingOption="whopqt-10-7">Envelope.CombineType</validator>
			</validation>
			<validation id="G.07" description="Only specified combinations of Application type and Submission Unit type are valid for the first eCTD formatted submission for a product." severity="Error">
				<validator type="log" dependingOption="whopqt-10-7">Envelope.Combine3Type</validator>
			</validation>
		</validation>
		<validation id="8" description="H - Quality">
			<validation id="H.01" description="The overall validation result should not exceed 50 best practice notifications." severity="Error">
				<validator type="log" dependingOption="whopqt-10-8">Exceed50Warning</validator>
			</validation>
			<validation id="H.02" description="Node Extensions in M1 should only be represented in the XML backbone, no additional directory should be created" severity="Error">
				<validator type="log" dependingOption="whopqt-10-8">FolderNodeExtensionInM1</validator>
			</validation>
			<validation id="H.03" description="For every node-extension the 'title' attribute is not empty" severity="Error">
				<validator type="log" dependingOption="whopqt-10-8">NodeExtension.Title.Empty</validator>
				<validator type="log" dependingOption="whopqt-10-8">Leaf.Title.Empty</validator>
			</validation>
		</validation>
		<validation id="9" description="Recommended">
			<validation id="Recommended" description="Ensure that 'checksum' attribute is present and value for the attribute is provided (i.e. not empty string) when 'operation' attribute for the leaf(s) is 'new', 'append' or 'replace'" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">Checksum.IsNotPresent</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'checksum' attribute value is not provided when 'operation' attribute for the leaf(s) is 'delete'" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">Checksum.IsPresent</validator>
			</validation>
			<validation id="Recommended" description="Ensure that invalid formatting is not provided for 'checksum' in index-md5.txt (32 characters are not specified for the MD5 checksum, or included trailing spaces or carriage returns)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">Index.Checksum.InvalidFormat</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all files must have one and only one file extension" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">InconsistentExtensions</validator>
			</validation>
			<validation id="Recommended" description="Ensure there is no reference leaf(s) point to a file (outside of the eCTD lifecycle) across application (xlink:href points to a different application)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">References.AcrossApplication</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the xlink:href and/or modified-file attribute conforms to the eCTD standard (valid characters - no backslash '\', colon':', asterisk'*', question mark'?', less than'&lt;', greater than'&gt;', pipe' | ', or space ' ', file path relative to the backbone xml files and includes file name in the path)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">Attribute.InvalidCharacters</validator>
				<validator type="log" dependingOption="whopqt-10-9">HrefRelativePath</validator>
				<validator type="log" dependingOption="whopqt-10-9">ModifiedFileRelativePath</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'util' folder exists and is in the correct location (&lt;sequence number&gt;/util)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">Util.NotExisted</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the syntax of the modified-file attribute is in accordance with the ICH 3.2 DTD version" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">ModifiedFile.IncorrectSyntax</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all files and folders in the submission are accessible to the user. " severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">AccessibleFileFolder</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the hyperlinks and/or bookmarks in the submission documents does not target document outside current eCTD application" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">RefOutsideSeqOrApp</validator>
				<validator type="log" dependingOption="whopqt-10-9">RefOutsideSeqOrAppBookmark</validator>
			</validation>
			<validation id="Recommended" description="Provide list of all documents in the submission containing annotation (other than links and bookmarks)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">PdfAnnotations</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all pdf documents in the submission must not have any attachments" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">PdfAttachmentDetected</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all hyperlinks and bookmarks in the submission documents must not have multiple actions (e.g. opening two different pages)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">PdfMultipleAction</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfMultipleActionBookmark</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all hyperlinks and bookmarks (internal, external, same sequence, across sequences and across applications) in the submission documents are not inactive (without any action)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">PdfInactiveBookmarkHyperlink</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfInactiveBookmark</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all hyperlinks and bookmarks in the submission documents must not have unknown action (links that could not be identified or contain JavaScript code) and print total count" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">PdfUnknownAction</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfUnknownActionBookmark</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalUnknownActionBookmarks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalUnknownActionHyperLinks</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all hyperlinks and bookmarks in the submission documents must not point to external destinations (other than web or email)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">PdfExternalDestinationHyperLink</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfExternalDestinationBookmark</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all hyperlinks and bookmarks in the submission documents must not point to web address or email" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">Pdf.UseURLLink</validator>
				<validator type="log" dependingOption="whopqt-10-9">ExternalBookmark</validator>
			</validation>
			<validation id="Recommended" description="
              Print the count of all of the hyperlinks and the bookmarks with following criteria:
						- Non-Relative Hyperlinks
						- Non-Relative Bookmarks
						- Web link and email hyperlinks
						- Web links and email bookmarks
						- External Hyperlinks (excluding web links and emails)
						- External Bookmarks (excluding web links and emails)
						- Unknown Action Hyperlinks
						- Unknown Action Bookmarks
						- Inactive Hyperlinks
						- Inactive Bookmarks
						- Broken Hyperlinks (separate count for inter-application, intra-application and intra-sequence)
						- Broken Bookmarks (separate count for inter-application, intra-application and intra-sequence)
						- Number of bookmarks per document
						- Total number of bookmarks in the submission
						- Number of hyperlinks per document
						- Total number of hyperlinks in the submission
                  " severity="Information">
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalNonRelativeBookmarks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalWebEmailDestinationBookmarks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalExternalDestinationBookmarks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalUnknownActionBookmarks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalInActiveBookmarks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalBrokenBookmarks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfNumberOfBookmarksPerDocument</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalBookmarksInSubmission</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalNonRelativeHyperLinks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalWebEmailDestinationHyperLinks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalExternalDestinationHyperLinks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalUnknownActionHyperLinks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalInActiveHyperLinks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalBrokenHyperLinks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalHyperLinks</validator>
				<validator type="log" dependingOption="whopqt-10-9">PdfTotalHyperLinksInSubmission</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the link and/or bookmark destination does not point to a corrupt document" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">RefDocCorrupted</validator>
				<validator type="log" dependingOption="whopqt-10-9">RefDocCorruptedBookmark</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the links and/or bookmark in the submission documents point to an existing page and/or named destinations." severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">BlankLinkInPdf</validator>
				<validator type="log" dependingOption="whopqt-10-9">BlankLinkInPdfBookmark</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all documents in the submission are text searchable" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">PdfDocContainsNoText</validator>
			</validation>
			<validation id="Recommended" description="Ensure that fonts referenced by the PDF documents in the submission are standard fonts and all non-standard fonts are fully embedded" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">PdfNonStandardFont</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'title' element of the 'leaf' and/or 'node-extension' does not begins or ends with a space." severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">Leaf.Title.LeadsOrEndsWithSpace</validator>
				<validator type="log" dependingOption="whopqt-10-9">NodeExtension.Title.LeadsOrEndsWithSpace</validator>
			</validation>
			<validation id="Recommended" description="Ensure that valid/supported 'dtd-version' is referenced in the ICH and regional backbone xml files." severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">DtdVersion.Invalid</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'dtd-version' is referenced in the ICH and regional backbone xml files." severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">IchDtdVersion</validator>
				<validator type="log" dependingOption="whopqt-10-9">RegionalDtdVersion</validator>
			</validation>
			<validation id="Recommended" description="Ensure that required attributes (e.g. 'indication' in the section 5.3.5 element or 'type of control' in the STF XML file for a study in section 5.3.5.1) are present in the back bone xmls (index and regional) and in the heading element of STF XML file(s)." severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">AttributeMissing</validator>
			</validation>
			<validation id="Recommended" description="Ensure that attribute (i.e. substance, company-name, species) values in ICH, regional and/or STF backbone files  does not begins or ends with a space." severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">SpaceInAttribute</validator>
			</validation>
			<validation id="Recommended" description="Ensure that non-required files are not present in the util folder (i.e. submission does not have an stf or leaf but the stylesheet and dtd files are present in the util folder)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">File.Extra.InUtil</validator>
			</validation>
			<validation id="Recommended" description="Ensure that operation attribute is present and valid value ('new', 'append', 'replace' or 'delete') for the attribute is provided. The system shall include in the message the name of the file where operation attribute is not present and/or valid value is not provided." severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">InvalidLeafOperation</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'operation' attributes for cover letter and application form leaf must be 'new'" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">Operation.InvalidNewOperation</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'append' operation is not applied on an existing lifecycle 'append' leaf (E.g. Detect invalid life cycle pattern: sequence 0001 appends a document in sequence 0000, sequence 0002 append operation leads to the append in 0001.)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">InvalidLifeCyclePatternAppendOnAppend</validator>
			</validation>
			<validation id="Recommended" description="Ensure that leaf lifecycle operation ('append', 'replace' or 'delete') is not applied to a lifecycle 'delete' leaf (E.g. sequence 0001 deletes a document in sequence 0000, sequence 0002 any life cycle operation leads to the already deleted leaf in 0001.)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">InvalidLifeCycleOperation.MultipleDelete</validator>
			</validation>
			<validation id="Recommended" description="Ensure that a leaf is not lifecycled ('append', 'replace' or 'delete') by more than one leaf to cause branching (i.e. scenario where a append/replace/delete operation is being applied on a leaf, which has already been replaced by another leaf. E.g. sequence 0001 replaces a document in sequence 0000, sequence 0002 append operation leads to the already replaced leaf in 0000.)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">InvalidLifeCycleOperation.Append</validator>
				<validator type="log" dependingOption="whopqt-10-9">InvalidLifeCycleOperation.Replace</validator>
				<validator type="log" dependingOption="whopqt-10-9">InvalidLifeCycleOperation.Delete</validator>
			</validation>
			<validation id="Recommended" description="Ensure same xlink:href is not referenced more than once in the backbone xml files" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">Href.Reused</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all element in the submission backbone xml files must have leaf child nodes" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">NoneLeafElement</validator>
			</validation>
			<validation id="Recommended" description="Ensure that xlink:href attribute in backbone xml files does not point to leaf outside current sequence" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">References.FilesOutsideSequence</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'xlink:href' attribute in backbone xml files does not point to leaf outside application" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">References.FilesOutsideApplication</validator>
			</validation>
			<validation id="Recommended" description="Ensure that only operation 'new' is used for all leafs in the initial sequence of the application" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">OperationNew</validator>
			</validation>
			<validation id="Recommended" description="Ensure multiple lifecycle operations on same document in same sequence are not allowed (E.g. sequence 0001 includes two lifecylce operations referencing the same leaf in sequence 0000.)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">MultipleOperationOnSingleLeaf</validator>
			</validation>
			<validation id="Recommended" description="Ensure attribute (if present i.e. indication, excipient, dosage-form, manufacturer, product-name, substance etc.) value must not be empty string" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">ICHMetadataAttribute.EmptyValue</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the initial sequence of the application must be '0000'" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">InitialSequence.Invalid</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the sequence being validated is the highest sequence in the application" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">CA.HighestSequence.Invalid</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the reference for the regional xml backbone file in index.xml must have operation attribute value 'new'" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">RegionalBackboneReferenced.WrongOperationAttribute</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'm1' folder must exist in the submission" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">M1Folder.NotExist</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the sequence numbers in an application are increased incrementally (The sequence number related to the life cycle should increase incrementally with each subsequent submission, for example 0000, 0001, 0002 etc. (the increase should occur in chronological order)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">SequenceNumber.IncreasesIncrementally</validator>
			</validation>
			<validation id="Recommended" description="Ensure PDF documents with more than 10 pages must have bookmarks" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">Pdf.Bookmark</validator>
			</validation>
			<validation id="Recommended" description="Ensure to find all documents where copying the content is not allowed." severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">PdfCopyingNotAllowed</validator>
			</validation>
			<validation id="Recommended" description="Ensure that PDF documents in the submission do not include JavaScript, 3D contents or dynamic contents (audio/video)" severity="Warning">
				<validator type="log" dependingOption="whopqt-10-9">Pdf.RestrictedContents</validator>
			</validation>
		</validation>
	</validations>
</validationreport>