﻿<?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="ZA Criteria">
		<validation id="1" description="1 - ICH DTD">
			<validation id="1.1" description="The ICH DTD is named correctly." severity="Error">
				<validator type="log" dependingOption="za-20-1">RegionalDtdExists</validator>
				<validator type="log" dependingOption="za-20-1">RegionalModFileExist</validator>
				<validator type="log" dependingOption="za-20-1">UtilFilesInvalidPath</validator>
				<validator type="log" dependingOption="za-20-1">IchDtdExists</validator>
			</validation>
			<validation id="1.2" description="The ICH DTD is placed in the correct folder." severity="Error">
				<validator type="log" dependingOption="za-20-1">RegionalDtdExists</validator>
				<validator type="log" dependingOption="za-20-1">Util.NotExisted</validator>
				<validator type="log" dependingOption="za-20-1">RegionalModFileExist</validator>
				<validator type="log" dependingOption="za-20-1">UtilFilesInvalidPath</validator>
				<validator type="log" dependingOption="za-20-1">IchDtdExists</validator>
			</validation>
			<validation id="1.3" description="A currently acceptable version of the ICH DTD is used (checksum matches the published value)." severity="Error">
				<validator type="log" dependingOption="za-20-1">IchChecksumFailed</validator>
			</validation>
			<validation id="1.4" description="The version number of the ICH DTD/specification 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="za-20-1">IchDtdVersionPreceding</validator>
			</validation>
			<validation id="1.5" description="The version number of the ICH DTD/specification 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="za-20-1">IchDtdVersionSucceeding</validator>
			</validation>
		</validation>
		<validation id="2" description="2 - ICH Stylesheet">
			<validation id="2.1" description="The specified filename is used." severity="Error">
				<validator type="log" dependingOption="za-20-2">StyleSheetExist</validator>
			</validation>
			<validation id="2.2" description="The file is placed in the correct folder." severity="Error">
				<validator type="log" dependingOption="za-20-2">Util.NotExisted</validator>
				<validator type="log" dependingOption="za-20-2">StyleSheetExist</validator>
			</validation>
			<validation id="2.3" description="The checksum for the stylesheet used must match the published checksum for the stylesheet associated with the DTD used for the sequence." severity="Error">
				<validator type="log" dependingOption="za-20-2">StyleSheetChecksumFailed</validator>
			</validation>
		</validation>
		<validation id="3" description="3 - Index XML">
			<validation id="3.1" description="The index.xml is placed in the folder xxxx." severity="Error">
				<validator type="log" dependingOption="za-20-3">Backbone.NotExist</validator>
				<validator type="log" dependingOption="za-20-3">Regional.Backbone.Multiple</validator>
			</validation>
			<validation id="3.2" description="There is a backbone file named index.xml." severity="Error">
				<validator type="log" dependingOption="za-20-3">Backbone.NotExist</validator>
				<validator type="log" dependingOption="za-20-3">Regional.Backbone.Multiple</validator>
			</validation>
			<validation id="3.3" description="The index.xml file is well formed." severity="Error">
				<validator type="log" dependingOption="za-20-3">Xml</validator>
			</validation>
			<validation id="3.4" description="The index.xml file is valid." severity="Error">
				<validator type="log" dependingOption="za-20-3">Xml</validator>
			</validation>
			<validation id="3.5" 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="za-20-3">Xml</validator>
			</validation>
			<validation id="3.6" description="The reference to the stylesheet in index.xml is directed to the stylesheet provided in the util folder." severity="Error">
				<validator type="log" dependingOption="za-20-3">InvalidStyleSheetLocation</validator>
			</validation>
		</validation>
		<validation id="4" description="4 - Index MD5">
			<validation id="4.1" description="The file is placed in the correct folder." severity="Error">
				<validator type="log" dependingOption="za-20-4">SubmissionChecksumFileName.Failed</validator>
				<validator type="log" dependingOption="za-20-4">SubmissionChecksum.Failed</validator>
			</validation>
			<validation id="4.2" description="The file is named correctly." severity="Error">
				<validator type="log" dependingOption="za-20-4">SubmissionChecksumFileName.Failed</validator>
				<validator type="log" dependingOption="za-20-4">SubmissionChecksum.Failed</validator>
			</validation>
			<validation id="4.3" description="The checksum of the index.xml, when calculated by the validation tool, should match the checksum provided in the index-md5.txt" severity="Error">
				<validator type="log" dependingOption="za-20-4">Index.Checksum.Failed</validator>
			</validation>
		</validation>
		<validation id="5" description="5 - Checksum">
			<validation id="5.1" description="The checksum-type attribute must have the value md5 or MD5." severity="Error">
				<validator type="log" dependingOption="za-20-5">ChecksumType.Incorrect</validator>
			</validation>
		</validation>
		<validation id="6" description="6 - Sequence Number">
			<validation id="6.1" description="The sequence number is 4 digits (i.e. numbers between 0000 and 9999)" severity="Error">
				<validator type="log" dependingOption="za-20-6">SequenceNumberCharacters</validator>
			</validation>
			<validation id="6.2" description="The sequence number has not already been used*" severity="Error">
				<validator type="log" dependingOption="za-20-6">SameSequenceNumber</validator>
			</validation>
			<validation id="6.3" description="The sequence folder name matches the sequence number in the za- envelope in za-regional.xml" severity="Error">
				<validator type="log" dependingOption="za-20-6">SequenceNumberNotMatch</validator>
				<validator type="log" dependingOption="za-20-6">SequenceNumberNumeric</validator>
			</validation>
		</validation>
		<validation id="7" description="7 - ZA M1 DTD">
			<validation id="7.1" description="The ZA M1 DTD is named correctly." severity="Error">
				<validator type="log" dependingOption="za-20-7">RegionalDtdExists</validator>
				<validator type="log" dependingOption="za-20-7">RegionalModFileExist</validator>
				<validator type="log" dependingOption="za-20-7">UtilFilesInvalidPath</validator>
				<validator type="log" dependingOption="za-20-7">IchDtdExists</validator>
			</validation>
			<validation id="7.2" description="The ZA M1 DTD is placed in the correct folder." severity="Error">
				<validator type="log" dependingOption="za-20-7">RegionalDtdExists</validator>
				<validator type="log" dependingOption="za-20-7">RegionalModFileExist</validator>
				<validator type="log" dependingOption="za-20-7">UtilFilesInvalidPath</validator>
				<validator type="log" dependingOption="za-20-7">IchDtdExists</validator>
			</validation>
			<validation id="7.3" description="A currently acceptable version of the ZA M1 DTD is used (checksum matches the published value)." severity="Error">
				<validator type="log" dependingOption="za-20-7">DtdChecksumFailed</validator>
			</validation>
			<validation id="7.4" description="The version number of the ZA M1 DTD/specification used in the sequence being tested is higher than or equal to the version of the ZA M1 DTD used in the sequence numerically preceding the incoming sequence in the eCTD lifecycle." severity="Error">
				<validator type="log" dependingOption="za-20-7">RegionalDtdVersionPreceding</validator>
			</validation>
			<validation id="7.5" description="The version number of the ZA M1 DTD/specification used in the sequence being tested is lower than or equal to the version of the ZA M1 DTD used in the sequence numerically succeeding the incoming sequence in the eCTD lifecycle." severity="Error">
				<validator type="log" dependingOption="za-20-7">RegionalDtdVersionSucceeding</validator>
			</validation>
		</validation>
		<validation id="8" description="8 - ZA Regional XML">
			<validation id="8.1" description="The za-regional.xml is placed in the folder xxxx/m1/za." severity="Error">
				<validator type="log" dependingOption="za-20-8">Backbone.NotExist</validator>
				<validator type="log" dependingOption="za-20-8">Regional.Backbone.Multiple</validator>
			</validation>
			<validation id="8.2" description="There is a ZA M1 backbone file named za-regional.xml." severity="Error">
				<validator type="log" dependingOption="za-20-8">Backbone.NotExist</validator>
				<validator type="log" dependingOption="za-20-8">Regional.Backbone.Multiple</validator>
			</validation>
			<validation id="8.3" description="The za-regional.xml is well formed." severity="Error">
				<validator type="log" dependingOption="za-20-8">Xml</validator>
			</validation>
			<validation id="8.4" description="The za-regional.xml is valid." severity="Error">
				<validator type="log" dependingOption="za-20-8">Xml</validator>
			</validation>
			<validation id="8.5" description="The reference to the DTD in za-regional.xml is directed to the DTD provided in the util folder." severity="Error">
				<validator type="log" dependingOption="za-20-8">InvalidSchemaOrDtdLocation</validator>
			</validation>
			<validation id="8.6" description="The reference to the stylesheet in za-regional.xml is directed to the stylesheet provided in the util folder." severity="Error">
				<validator type="log" dependingOption="za-20-8">InvalidStyleSheetLocation</validator>
			</validation>
		</validation>
		<validation id="9" description="9 - ZA Module 1">
			<validation id="9.1" description="A Letter of application must exist in section 1.0." severity="Error">
				<validator type="log" dependingOption="za-20-9">InvalidLetterOfApplication</validator>
			</validation>
			<validation id="9.2" description="The operation attribute of the Letter of application must be new." severity="Error">
				<validator type="log" dependingOption="za-20-9">Operation.InvalidNewOperation</validator>
				<validator type="log" dependingOption="za-20-9">Operation.ApplicationForm</validator>
				<validator type="log" dependingOption="za-20-9">Operation.CoverLetter</validator>
			</validation>
			<validation id="9.3" description="An Application Form must exist in section 1.2.1." severity="Error">
				<validator type="log" dependingOption="za-20-9">ApplicationForm.NotExist</validator>
			</validation>
			<validation id="9.4" description="An Electronic copy declaration must exist in section 1.2.2.4." severity="Error">
				<validator type="log" dependingOption="za-20-9">ElectronicCopyDeclaration.NotExist</validator>
			</validation>
			<validation id="9.5" description="A Validation Template has to exist in section 1.8." severity="Error">
				<validator type="log" dependingOption="za-20-9">ValidationTemplate.NotExist</validator>
			</validation>
			<validation id="9.BP1" description="The operation attribute of the Application form should be new." severity="Warning">
				<validator type="log" dependingOption="za-20-9">Operation.InvalidNewOperation</validator>
				<validator type="log" dependingOption="za-20-9">Operation.ApplicationForm</validator>
				<validator type="log" dependingOption="za-20-9">Operation.CoverLetter</validator>
			</validation>
			<validation id="9.BP2" description="The operation attribute of the Proof of payment should be new." severity="Warning">
				<validator type="log" dependingOption="za-20-9">Operation.InvalidNewOperation</validator>
			</validation>
			<validation id="9.BP3" description="The operation attribute of the Electronic copy declaration should be new." severity="Warning">
				<validator type="log" dependingOption="za-20-9">Operation.InvalidNewOperation</validator>
			</validation>
			<validation id="9.BP4" description="The operation attribute of the Tabulated Schedule of Amendments should be new." severity="Warning">
				<validator type="log" dependingOption="za-20-9">Operation.InvalidNewOperation</validator>
			</validation>
			<validation id="9.BP5" description="The cross-references in the Patient Information Leaflet in section 1.3.2 should be hyperlinked to the package insert in section 1.3.1.1." severity="Warning">
				<validator type="log" dependingOption="za-20-9">CrossReferencePatientInformationLeaflet</validator>
			</validation>
			<validation id="9.BP6" description="The cross-references in the package insert in section 1.3.1.1 should be hyperlinked to the actual references." severity="Warning">
				<validator type="log" dependingOption="za-20-9">ActualCrossReferencePackageInsert</validator>
			</validation>
			<validation id="9.BP7" description="The references in Sections B to D of the Validation template in section 1.8 should be hyperlinked to the respective documents in the eCTD." severity="Warning">
				<validator type="log" dependingOption="za-20-9">SectionInValidationTemplate</validator>
			</validation>
			<validation id="9.BP8" description="The references in the “Tabulated Schedule of Amendments” should be hyperlinked to the relevant documents dealing with the recommendations and responses." severity="Warning">
				<validator type="log" dependingOption="za-20-9">LinkToRelevantDocument</validator>
			</validation>
			<validation id="9.BP9" description="A Tabulated Schedule of Amendments must exist in section 1.5.2.1." severity="Warning">
				<validator type="log" dependingOption="za-20-9">AmendmentDocument.NotExist</validator>
			</validation>
		</validation>
		<validation id="10" description="10 - ZA M1 Envelope MOD File">
			<validation id="10.1" description="The ZA M1 envelope MOD file is named correctly." severity="Error">
				<validator type="log" dependingOption="za-20-10">UtilFilesInvalidPath</validator>
			</validation>
			<validation id="10.2" description="The ZA M1 envelope MOD file is placed in the correct folder." severity="Error">
				<validator type="log" dependingOption="za-20-10">UtilFilesInvalidPath</validator>
			</validation>
			<validation id="10.3" description="The checksum for the za-envelope.mod file used must match the published checksum for the za-envelope.mod file associated with the DTD used for the sequence." severity="Error">
				<validator type="log" dependingOption="za-20-10">DtdChecksumFailed</validator>
			</validation>
		</validation>
		<validation id="11" description="11 - ZA M1 Leaf MOD File">
			<validation id="11.1" description="The ZA M1 leaf MOD file is named correctly." severity="Error">
				<validator type="log" dependingOption="za-20-11">UtilFilesInvalidPath</validator>
			</validation>
			<validation id="11.2" description="The ZA M1 leaf MOD file is placed in the correct folder." severity="Error">
				<validator type="log" dependingOption="za-20-11">UtilFilesInvalidPath</validator>
			</validation>
			<validation id="11.3" description="The checksum for the za-leaf.mod file used must match the published checksum for the za-leaf.mod file associated with the DTD used for the sequence." severity="Error">
				<validator type="log" dependingOption="za-20-11">DtdChecksumFailed</validator>
			</validation>
		</validation>
		<validation id="12" description="12- ZA M1 Stylesheet">
			<validation id="12.1" description="The ZA M1 leaf MOD file is named correctly." severity="Error">
				<validator type="log" dependingOption="za-20-12">StyleSheetExist</validator>
			</validation>
			<validation id="12.2" description="The ZA M1 leaf MOD file is placed in the correct folder." severity="Error">
				<validator type="log" dependingOption="za-20-12">StyleSheetExist</validator>
			</validation>
			<validation id="12.3" description="The checksum for the za-leaf.mod file used must match the published checksum for the za-leaf.mod file associated with the DTD used for the sequence." severity="Error">
				<validator type="log" dependingOption="za-20-12">StyleSheetChecksumFailed</validator>
			</validation>
		</validation>
		<validation id="13" description="13 - Node Extension">
			<validation id="13.1" description="For every node-extension the &quot;title&quot; attribute is not empty." severity="Error">
				<validator type="log" dependingOption="za-20-13">NodeExtension.Title.Empty</validator>
				<validator type="log" dependingOption="za-20-13">Leaf.Title.Empty</validator>
			</validation>
		</validation>
		<validation id="14" description="14 - Files/Folders">
			<validation id="14.1" description="The files provided in the folders for Module 1 are in acceptable formats." severity="Error">
				<validator type="log" dependingOption="za-20-14">FileType.Invalid</validator>
			</validation>
			<validation id="14.2" description="The files provided in the folders for Module 2-5 are in acceptable formats." severity="Error">
				<validator type="log" dependingOption="za-20-14">FileType.Invalid</validator>
			</validation>
			<validation id="14.3" description="Total folder/file path does not exceed 180 characters." severity="Error">
				<validator type="log" dependingOption="za-20-14">LongPath</validator>
			</validation>
			<validation id="14.4" description="File names do not exceed 64 characters." severity="Error">
				<validator type="log" dependingOption="za-20-14">CA.LongFileName</validator>
				<validator type="log" dependingOption="za-20-14">LongFileName</validator>
				<validator type="log" dependingOption="za-20-14">LongFileName</validator>
			</validation>
			<validation id="14.5" description="Folder names must not exceed 64 characters." severity="Error">
				<validator type="log" dependingOption="za-20-14">CA.LongFileName</validator>
				<validator type="log" dependingOption="za-20-14">LongFileName</validator>
			</validation>
			<validation id="14.6" description="All characters used in referenced file names are valid (according to the name requirements of the ICH eCTD Specification)." severity="Error">
				<validator type="log" dependingOption="za-20-14">Path.Invalid</validator>
				<validator type="log" dependingOption="za-20-14">Path.Case</validator>
			</validation>
			<validation id="14.7" description="All characters used in folder names are valid (according to the name requirements of the ICH eCTD Specification)." severity="Error">
				<validator type="log" dependingOption="za-20-14">Path.Invalid</validator>
				<validator type="log" dependingOption="za-20-14">Path.Case</validator>
			</validation>
			<validation id="14.8" description="There are no empty folders" severity="Error">
				<validator type="log" dependingOption="za-20-14">EmptyFolder</validator>
			</validation>
			<validation id="14.9" description="There are no unreferenced files in M1, M2, M3, M4 and M5 folders (including sub-folders but excluding 'util' subfolders)." severity="Error">
				<validator type="log" dependingOption="za-20-14">File.Extra</validator>
				<validator type="log" dependingOption="za-20-14">SubmissionFolder.RedundantFiles</validator>
				<validator type="log" dependingOption="za-20-14">M1Folder.RedundantFiles</validator>
			</validation>
			<validation id="14.10" description="The only files in the root folder are the index.xml and index-md5.txt." severity="Error">
				<validator type="log" dependingOption="za-20-14">File.Extra</validator>
				<validator type="log" dependingOption="za-20-14">SubmissionFolder.RedundantFiles</validator>
				<validator type="log" dependingOption="za-20-14">M1Folder.RedundantFiles</validator>
			</validation>
			<validation id="14.BP1" description="Individual files do not exceed 200 MB in size." severity="Warning">
				<validator type="log" dependingOption="za-20-14">File.Size</validator>
			</validation>
			<validation id="14.BP2" description="The recommended folder structure and folder names from the ICH and ZA specifications are used." severity="Warning">
				<validator type="log" dependingOption="za-20-14">M1.NamingConvention.NotMatch</validator>
				<validator type="log" dependingOption="za-20-14">NamingConvention.Inconsistent</validator>
			</validation>
			<validation id="14.BP3" description="The recommended file names from the ICH and ZA specifications are used for all files." severity="Warning">
				<validator type="log" dependingOption="za-20-14">M1.NamingConvention.NotMatch</validator>
				<validator type="log" dependingOption="za-20-14">NamingConvention.Inconsistent</validator>
			</validation>
			<validation id="14.BP4" description="All files should have one and only one file extension. The file extension should be used to indicate the format of the file." severity="Warning">
				<validator type="log" dependingOption="za-20-14">InconsistentExtensions</validator>
			</validation>
			<validation id="14.BP5" description="If documents are placed in section 3.2.R (including subfolders), the structure must follow the structure given in the ZA M1 specification." severity="Warning">
				<validator type="log" dependingOption="za-20-14">32RDocument.Structure</validator>
			</validation>
		</validation>
		<validation id="15" description="15 - ID Attributes">
			<validation id="15.BP1" description="The ID attribute value starts with a letter or underscore character." severity="Warning">
				<validator type="log" dependingOption="za-20-15">LeafId.Invalid</validator>
			</validation>
		</validation>
		<validation id="16" description="16 - Leaf">
			<validation id="16.BP1" description="Checks for elements not having any leaf child nodes - all the lowest level heading elements included in the submission contain at least one leaf." severity="Warning">
				<validator type="log" dependingOption="za-20-16">FolderEmpty</validator>
				<validator type="log" dependingOption="za-20-16">ValidationFailed</validator>
			</validation>
		</validation>
		<validation id="17" description="17 - Leaf Attributes">
			<validation id="17.1" description="The regenerated checksum for every referenced file is the same as each associated checksum provided in the backbone file (e.g. za- regional.xml)." severity="Error">
				<validator type="log" dependingOption="za-20-17">Checksum.Failed</validator>
			</validation>
			<validation id="17.2" description="For every leaf the &quot;title&quot; attribute is not empty." severity="Error">
				<validator type="log" dependingOption="za-20-17">Leaf.TitleAttribute.Empty</validator>
			</validation>
			<validation id="17.3" 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="za-20-17">ModifiedFile.Unverifiable</validator>
			</validation>
			<validation id="17.4" description="All leaves with an operation attribute value of new must have no value for modified-file." severity="Error">
				<validator type="log" dependingOption="za-20-17">ModifiedFileExist</validator>
			</validation>
			<validation id="17.5" description="The syntax of the modified file entry is in accordance with ICH 3.0 or 3.2: If the operation is append, replace or delete, then the modified file attribute must use the correct syntax (i.e. modified- file=&quot;../0001/index.xml#a1234567&quot;)" severity="Error">
				<validator type="log" dependingOption="za-20-17">ModifiedFile.IncorrectSyntax</validator>
			</validation>
			<validation id="17.BP1" description="No modified file references an invalid document: If the operation is append, replace or delete, then the modified file attribute should point to a valid document." severity="Warning">
				<validator type="log" dependingOption="za-20-17">ModifiedFileNotFound</validator>
			</validation>
		</validation>
		<validation id="18" description="18 - Xlink:Href">
			<validation id="18.1" description="xlink:href conforms to the eCTD standard (using the relative path to the file and file name)" severity="Error">
				<validator type="log" dependingOption="za-20-18">ModifiedFileRelativePath</validator>
				<validator type="log" dependingOption="za-20-18">HrefRelativePath</validator>
				<validator type="log" dependingOption="za-20-18">Attribute.InvalidCharacters</validator>
			</validation>
			<validation id="18.2" description="If the operation is new, append or replace, then xlink:href should point to a document" severity="Error">
				<validator type="log" dependingOption="za-20-18">BlankHref</validator>
			</validation>
			<validation id="18.3" description="If the operation is delete, then xlink:href should not exist." severity="Error">
				<validator type="log" dependingOption="za-20-18">DeletedLeaf.Href.NotBlank</validator>
			</validation>
			<validation id="18.4" description="No references in index files (xlink:href) should target files outside the eCTD life cycle." severity="Error">
				<validator type="log" dependingOption="za-20-18">References.AcrossApplication</validator>
			</validation>
		</validation>
		<validation id="19" description="19 - Modified File">
			<validation id="19.1" description="For all leaves except leaves within node extensions within the same CTD section with an operation attribute value of replace, delete or append, the modified file must be present in the same CTD section of the dossier." severity="Error">
				<validator type="log" dependingOption="za-20-19">ModifiedFile.NotInSameSection</validator>
			</validation>
			<validation id="19.BP1" description="For all leaves within node extensions within the same CTD section with an operation attribute value of replace, delete or append, the modified file should be present in the same node extension." severity="Warning">
				<validator type="log" dependingOption="za-20-19">ModifiedFile.NotInSameNodeExtension</validator>
			</validation>
		</validation>
		<validation id="20" description="20 - PDF Files">
			<validation id="20.1" description="No PDF has been created and saved as version 1.3 or earlier" severity="Error">
				<validator type="log" dependingOption="za-20-20">Pdf.UnsupportedPdfVersion</validator>
			</validation>
			<validation id="20.2" description="There is no security setting or password protection to open any individual file." severity="Error">
				<validator type="log" dependingOption="za-20-20">PdfSecurity</validator>
			</validation>
			<validation id="20.3" description="There are no further security settings applied to any individual file." severity="Error">
				<validator type="log" dependingOption="za-20-20">PdfSecurity</validator>
			</validation>
			<validation id="20.4" description="The submission does not contain corrupted files." severity="Error">
				<validator type="log" dependingOption="za-20-20">RefDocCorrupted</validator>
				<validator type="log" dependingOption="za-20-20">RefDocCorruptedBookmark</validator>
			</validation>
			<validation id="20.BP1" description="PDF Format is PDF 1.4, 1.5 , 1.6, or 1.7" severity="Error">
				<validator type="log" dependingOption="za-20-20">Pdf.UnsupportedPdfVersion</validator>
			</validation>
			<validation id="20.BP2" description="Hyperlinks and bookmarks within documents, or between documents within the same sequence, have a valid target." severity="Warning">
				<validator type="log" dependingOption="za-20-20">BrokenLinkInPdf</validator>
				<validator type="log" dependingOption="za-20-20">BookmarkBrokenLinkInPdf</validator>
			</validation>
			<validation id="20.BP3" description="Hyperlinks and bookmarks to destinations in a different sequence in the same eCTD have a valid target." severity="Warning">
				<validator type="log" dependingOption="za-20-20">BrokenLinkInPdf</validator>
				<validator type="log" dependingOption="za-20-20">BookmarkBrokenLinkInPdf</validator>
			</validation>
			<validation id="20.BP4" description="All hyperlinks and bookmarks are set to 'inherit zoom'." severity="Warning">
				<validator type="log" dependingOption="za-20-20">Pdf.InvalidMagnification</validator>
				<validator type="log" dependingOption="za-20-20">Bookmark.Pdf.InvalidMagnification</validator>
			</validation>
			<validation id="20.BP5" description="PDFs must have &quot;Fast Web View&quot; active." severity="Warning">
				<validator type="log" dependingOption="za-20-20">PdfFastWebAccess</validator>
			</validation>
			<validation id="20.BP6" description="PDF Document Properties for the Initial View are set for 'Page Layout = Default' and 'Magnification = Default'" severity="Warning">
				<validator type="log" dependingOption="za-20-20">Pdf.InvalidInitialView</validator>
			</validation>
			<validation id="20.BP7" description="All PDF links and Hyperlinks are relative (are not absolute or rooted)." severity="Warning">
				<validator type="log" dependingOption="za-20-20">AbsolutePathInPdf</validator>
				<validator type="log" dependingOption="za-20-20">AbsolutePathBookmarkInPdf</validator>
			</validation>
			<validation id="20.BP8" description="Bookmarks pane should be visible if bookmarks are included with a PDF document." severity="Warning">
				<validator type="log" dependingOption="za-20-20">Pdf.InvalidInitialView.Bookmark</validator>
			</validation>
			<validation id="20.BP9" description="The bookmarks panel should not be visible if there are no bookmarks included within a PDF document." severity="Warning">
				<validator type="log" dependingOption="za-20-20">InvalidPageModeWhenNoBookmark</validator>
			</validation>
			<validation id="20.BP10" description="All hyperlinks and bookmarks between two PDFs must be configured as specified in ISO 32000-1:2008" severity="Warning">
				<validator type="log" dependingOption="za-20-20">PdfBackslash</validator>
				<validator type="log" dependingOption="za-20-20">PdfBackslashBookmark</validator>
			</validation>
		</validation>
		<validation id="21" description="21 - Envelope Attributes">
			<validation id="21.BP1" description="If the submission type is a Response to a pre-registration recommendation or post-registration, then the related sequence attribute is a four digit number." severity="Warning">
				<validator type="log" dependingOption="za-20-21">SubmissionType.RelatedSequenceNumber.Fourdigit</validator>
			</validation>
			<validation id="21.BP2" description="If the submission type is not a Response to a pre-registration recommendation or post-registration, then the related sequence attribute must be &quot;none&quot;." severity="Warning">
				<validator type="log" dependingOption="za-20-21">SubmissionType.NoneRelatedSequenceNumber</validator>
			</validation>
		</validation>
		<validation id="22" 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="za-20-22">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="za-20-22">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="za-20-22">Index.Checksum.InvalidFormat</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the checksum of the DTD for STFs provided in the util folder must match the checksum value provided by the agency" severity="Warning">
				<validator type="log" dependingOption="za-20-22">StfChecksumFailed</validator>
			</validation>
			<validation id="Recommended" description="Allow users to configure file size limit for special file types (i.e. xpt). For all other file types (where configuration is not specified), default max file size value in the 'Check for File Size' field shall be used for validation" severity="Warning">
				<validator type="log" dependingOption="za-20-22">SpecialFile.Size</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the xlink:href attribute of the leaf points to a document (current sequence, previous sequence if allowed by the region, across application if allowed by the region) and it is exists in the referenced location" severity="Warning">
				<validator type="log" dependingOption="za-20-22">HrefPointToFile.NotExist</validator>
			</validation>
			<validation id="Recommended" description="Ensure that there are no corrupted/unreadable files in the submission (meaning PDF files can be opened by ISO 32000-1 compliant software.  Content is not invalid or the page count is not 0 or the encryption is not too strong)" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Pdf.Failed</validator>
			</validation>
			<validation id="Recommended" description="Ensure that ICH and regional xml backbone files are named correctly" severity="Warning">
				<validator type="log" dependingOption="za-20-22">EU_CH_GC_AUBackbone.NotExist</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="za-20-22">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="za-20-22">RefOutsideSeqOrApp</validator>
				<validator type="log" dependingOption="za-20-22">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="za-20-22">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="za-20-22">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="za-20-22">PdfMultipleAction</validator>
				<validator type="log" dependingOption="za-20-22">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="za-20-22">PdfInactiveBookmarkHyperlink</validator>
				<validator type="log" dependingOption="za-20-22">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="za-20-22">PdfUnknownAction</validator>
				<validator type="log" dependingOption="za-20-22">PdfUnknownActionBookmark</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="za-20-22">PdfExternalDestinationHyperLink</validator>
				<validator type="log" dependingOption="za-20-22">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="za-20-22">Pdf.UseURLLink</validator>
				<validator type="log" dependingOption="za-20-22">ExternalBookmark</validator>
			</validation>
			<validation id="Recommended" description="Print the count of all of the hyperlinks and the bookmarks with following criteria:&#xA;- Non-Relative Hyperlinks&#xA;- Non-Relative Bookmarks&#xA;- Web link and email hyperlinks&#xA;- Web links and email bookmarks&#xA;- External Hyperlinks (excluding web links and emails)&#xA;- External Bookmarks (excluding web links and emails)&#xA;- Unknown Action Hyperlinks&#xA;- Unknown Action Bookmarks&#xA;- Inactive Hyperlinks&#xA;- Inactive Bookmarks&#xA;- Broken Hyperlinks (separate count for inter-application, intra-application and intra-sequence)&#xA;- Broken Bookmarks (separate count for inter-application, intra-application and intra-sequence)&#xA;- Number of bookmarks per document&#xA;- Total number of bookmarks in the submission&#xA;- Number of hyperlinks per document&#xA;- Total number of hyperlinks in the submission" severity="Information">
				<validator type="log" dependingOption="za-20-22">PdfTotalNonRelativeBookmarks</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalWebEmailDestinationBookmarks</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalExternalDestinationBookmarks</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalUnknownActionBookmarks</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalInActiveBookmarks</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalBrokenBookmarks</validator>
				<validator type="log" dependingOption="za-20-22">PdfNumberOfBookmarksPerDocument</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalBookmarksInSubmission</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalNonRelativeHyperLinks</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalWebEmailDestinationHyperLinks</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalExternalDestinationHyperLinks</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalUnknownActionHyperLinks</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalInActiveHyperLinks</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalBrokenHyperLinks</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalHyperLinks</validator>
				<validator type="log" dependingOption="za-20-22">PdfTotalHyperLinksInSubmission</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="za-20-22">BlankLinkInPdf</validator>
				<validator type="log" dependingOption="za-20-22">BlankLinkInPdfBookmark</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'property' element (if present) is listed before its sibling 'file-tag' element in all of the stf files of the submission" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.PropertyBeforeFiletag</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'property' element is present in all of the stf files in the submission created with STF DTD v2.0 only" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.MissingProperty</validator>
			</validation>
			<validation id="Recommended" description="Ensure that child element 'title' is not provided in the doc-content of the STF files in the submission" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.TitleNotProvided</validator>
			</validation>
			<validation id="Recommended" description="Ensure that an STF xml file is referenced in a submission only once" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.ReferencedMultiple</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'title' element (within 'study-identifier') is present and value for title is provided in the STF xml file" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.Title.Empty</validator>
			</validation>
			<validation id="Recommended" description="Ensure that STF files are not missing in the submission (i.e. xlink:href contains ‘stf-xxxxxxxx.xml’ but system is not able to locate the file)" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.NotExist</validator>
			</validation>
			<validation id="Recommended" description="Ensure that STFs (files named as ‘stf-xxxxxxxxx.xml’) in the submission contain study-id information (element and the value is not empty) and reference leafs" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.StudyId.Empty</validator>
			</validation>
			<validation id="Recommended" description="Ensure that STF title (within study-identifier element) in the stf xml file matches with the leaf title for the stf in the index.xml file" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.Title.NotMatch</validator>
			</validation>
			<validation id="Recommended" description="Ensure that one and only one doc-content file-tag is specified for each file referenced in the STFs." severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.FileTag.NotExist1</validator>
			</validation>
			<validation id="Recommended" description="Ensure that STF is only referenced in the sections of M4 and M5 allowed as per the STF specification" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.WrongSection</validator>
			</validation>
			<validation id="Recommended" description="Ensure that STF’s in the submission are named correctly based on the naming convention i.e. ‘STF-&lt;study-id&gt;.xml’" severity="Warning">
				<validator type="log" dependingOption="za-20-22">InvalidStfFileName</validator>
			</validation>
			<validation id="Recommended" description="Ensure that STFs in the submission have valid file extension (file extension is not missing and it is .xml)" severity="Warning">
				<validator type="log" dependingOption="za-20-22">InvalidStfFileName</validator>
			</validation>
			<validation id="Recommended" description="Ensure that lifecycle stf must have the same study-id as the original stf (referenced by the modified-file)" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.StudyId.NotMatch</validator>
			</validation>
			<validation id="Recommended" description="Ensure that files referenced by an STF exist in the submission/application (referenced by index.xml)" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.LeafId.NotExist</validator>
			</validation>
			<validation id="Recommended" description="Ensure that STF file must reference at least one leaf element" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.NotHasReferencedLeaf</validator>
			</validation>
			<validation id="Recommended" description="Ensure that an STF file does not reference another STF file" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.ReferenceStf</validator>
			</validation>
			<validation id="Recommended" description="Ensure that files in study sections are referenced by an STF" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.NotReferencedInSTF</validator>
			</validation>
			<validation id="Recommended" description="Ensure that valid STF DTD version (e.g. dtd-version = &quot;2.2&quot;) is referenced in the STF XML file" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.UnsupportedSchemaVersion</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="za-20-22">Leaf.Title.LeadsOrEndsWithSpace</validator>
				<validator type="log" dependingOption="za-20-22">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="za-20-22">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="za-20-22">IchDtdVersion</validator>
				<validator type="log" dependingOption="za-20-22">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="za-20-22">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="za-20-22">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="za-20-22">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" severity="Warning">
				<validator type="log" dependingOption="za-20-22">InvalidLeafOperation</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'category' information must be provided for STFs in following sections: &#xA;• 4.2.3.1 Single dose toxicity section contains 'species' and 'route-of-admin'.&#xA;• 4.2.3.2 Repeat dose toxicity section contains 'species', 'route-of-admin', and&#xA;'duration' (if applicable).&#xA;• 4.2.3.4.1 Long term [carcinogenicity] studies contain 'species'.&#xA;• 5.3.5.1 Study reports of controlled clinical studies pertinent to the claimed&#xA;indication contain 'type-of-control’." severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.Category.Missing</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'modified-file' of lifecycle stf must point to a stf (e.g. not a pdf document)" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.Append.ReferenceOtherStf</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'file-tag' values and 'category' values are valid as per the 'valid-values.xml' file referenced by the submission" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.Category.NotSupported</validator>
				<validator type="log" dependingOption="za-20-22">Stf.FileTag.NotSupported</validator>
				<validator type="log" dependingOption="za-20-22">Stf.Property.NotSupported</validator>
			</validation>
			<validation id="Recommended" description="Ensure that value for study-identifier/category element must not be empty" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.Categories.Empty</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'xlink:href' attribute of a leaf referenced in an STF must exists and must not contain backslashes" severity="Warning">
				<validator type="log" dependingOption="za-20-22">StfHrefHasBackslashes</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the titles from the doc-content elements (if present) must match the corresponding leaf title values in the ICH backbone" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.DocContent.Title.NotMatch</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="za-20-22">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="za-20-22">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="za-20-22">InvalidLifeCycleOperation.Append</validator>
				<validator type="log" dependingOption="za-20-22">InvalidLifeCycleOperation.Delete</validator>
				<validator type="log" dependingOption="za-20-22">InvalidLifeCycleOperation.Replace</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="za-20-22">Href.Reused</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all element in the submission backbone xml files must have leaf child nodes" severity="Information">
				<validator type="log" dependingOption="za-20-22">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="Information">
				<validator type="log" dependingOption="za-20-22">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="za-20-22">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="za-20-22">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="za-20-22">MultipleOperationOnSingleLeaf</validator>
			</validation>
			<validation id="Recommended" description="Ensure that most recent stf (stf that was lifecycled last instead of previous or original stf) is lifecycled" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.AppendOperation</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="za-20-22">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="za-20-22">InitialSequence.Invalid</validator>
			</validation>
			<validation id="Recommended" description="Identify and report all invalid STF files. STF files with an incorrect name will be also reported" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.List</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="za-20-22">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="za-20-22">RegionalBackboneReferenced.WrongOperationAttribute</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'm1' folder must exist in the submission" severity="Warning">
				<validator type="log" dependingOption="za-20-22">M1Folder.NotExist</validator>
			</validation>
			<validation id="Recommended" description="Ensure that there is a stylesheet declaration in backbone xml files (index, regional and STF)" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Xml.StyleSheet</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="za-20-22">SequenceNumber.IncreasesIncrementally</validator>
			</validation>
			<validation id="Recommended" description="Ensure that TS.xpt is present in STF for module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4 and in module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.TrialSummary.Present</validator>
			</validation>
			<validation id="Recommended" description="Ensure that only one dataset of each type (filename configured) referenced in an STF is marked as 'new' operation&#xA;Note: This is applicable for :&#xA;Module 4 : section 4.2.3.1, 4.2.3.2, 4.2.3.4&#xA;Module 5:  section 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Stf.FileName.Specific</validator>
			</validation>
			<validation id="Recommended" description="Ensure PDF documents with more than 10 pages must have bookmarks" severity="Warning">
				<validator type="log" dependingOption="za-20-22">Pdf.Bookmark</validator>
			</validation>
		</validation>
	</validations>
</validationreport>