﻿<?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 - eCTD XML Identification">
      <validation id="1.1" description="XML Backbones Identification" severity="Error">
        <validator type="log" dependingOption="za-31-1">Backbone.NotExist</validator>
        <validator type="log" dependingOption="za-31-1">Regional.Backbone.Multiple</validator>
        <validator type="log" dependingOption="za-31-1">EU_CH_GC_AUBackbone.NotExist</validator>
        <validator type="log" dependingOption="za-31-1">IchDtdVersionPreceding</validator>
        <validator type="log" dependingOption="za-31-1">RegionalDtdVersionPreceding</validator>
        <validator type="log" dependingOption="za-31-1">IchDtdVersionSucceeding</validator>
        <validator type="log" dependingOption="za-31-1">RegionalDtdVersionSucceeding</validator>
      </validation>
      <validation id="1.2" description="STF Identification" severity="Error">
        <validator type="log" dependingOption="za-31-1">Stf.List</validator>
      </validation>
    </validation>
    <validation id="2" description="2 - Files/Folders">
      <validation id="2.1" description="2.1 Folders">
        <validation id="2.1.1" description="Folder name syntax must be correct" severity="Error">
          <validator type="log" dependingOption="za-31-2-1">LongFileName</validator>
          <validator type="log" dependingOption="za-31-2-1">Path.Invalid</validator>
          <validator type="log" dependingOption="za-31-2-1">Path.Case</validator>
        </validation>
        <validation id="2.1.2" description="Folders must not be empty" severity="Error">
          <validator type="log" dependingOption="za-31-2-1">EmptyFolder</validator>
        </validation>
        <validation id="2.1.3" description="Sequence Root folder does not contain unspecified files" severity="Error">
          <validator type="log" dependingOption="za-31-2-1">File.Extra</validator>
          <validator type="log" dependingOption="za-31-2-1">SubmissionFolder.RedundantFiles</validator>
        </validation>
        <validation id="2.1.4" description="Folder m1 exists and no files are placed there." severity="Error">
          <validator type="log" dependingOption="za-31-2-1">M1Folder.RedundantFiles</validator>
        </validation>
        <validation id="2.1.5" description="Only folders m2, m3, m4, m5 and util exist" severity="Error">
          <validator type="log" dependingOption="za-31-2-1">File.Extra</validator>
          <validator type="log" dependingOption="za-31-2-1">EmptyFolder</validator>
        </validation>
        <validation id="2.1.6" description="Folder util exists and contained files are correct" severity="Error">
          <validator type="log" dependingOption="za-31-2-1">StfChecksumFailed</validator>
          <validator type="log" dependingOption="za-31-2-1">Util.NotExisted</validator>
          <validator type="log" dependingOption="za-31-2-1">UtilFilesInvalidPath</validator>
          <validator type="log" dependingOption="za-31-2-1">IchChecksumFailed</validator>
          <validator type="log" dependingOption="za-31-2-1">DtdChecksumFailed</validator>
          <validator type="log" dependingOption="za-31-2-1">File.Extra.InUtil</validator>
          <validator type="log" dependingOption="za-31-2-1">StyleSheetChecksumFailed</validator>
          <validator type="log" dependingOption="za-31-2-1">Util.Checksum.Failed</validator>
          <validator type="log" dependingOption="za-31-2-1">StyleSheetExist</validator>
          <validator type="log" dependingOption="za-31-2-1">Folder.Extra.InUtil</validator>
        </validation>
        <validation id="2.1.7" description="Sequence folder should be four digits" severity="Error">
          <validator type="log" dependingOption="za-31-2-1">SequenceNumberCharacters</validator>
        </validation>
        <validation id="2.1.8" description="Applications should start with sequence folder 0001" severity="Error">
          <validator type="log" dependingOption="za-31-2-1">InitialSequence.Invalid</validator>
          <validator type="log" dependingOption="za-31-2-1">FirstSequence.Invalid</validator>
        </validation>
      </validation>
      <validation id="2.2" description="2.2 Files">
        <validation id="2.2.1" description="File name syntax must be correct" severity="Error">
          <validator type="log" dependingOption="za-31-2-2">LongPath</validator>
          <validator type="log" dependingOption="za-31-2-2">LongFileName</validator>
          <validator type="log" dependingOption="za-31-2-2">Path.Invalid</validator>
        </validation>
        <validation id="2.2.2" description="Unreferenced files are not allowed" severity="Error">
          <validator type="log" dependingOption="za-31-2-2">File.Extra</validator>
        </validation>
        <validation id="2.2.3" description="File size limits should not be exceeded" severity="Warning">
          <validator type="log" dependingOption="za-31-2-2">File.Size</validator>
        </validation>
        <validation id="2.2.4" description="File types (file extensions) check" severity="Warning">
          <validator type="log" dependingOption="za-31-2-2">InconsistentExtensions</validator>
          <validator type="log" dependingOption="za-31-2-2">FileType.Invalid</validator>
        </validation>
      </validation>
    </validation>
    <validation id="3" description="3 - ICH Backbone">
      <validation id="3.1" description="3.1 The index.xml">
        <validation id="3.1.1" description="File index.xml must exist" severity="Error">
          <validator type="log" dependingOption="za-31-3-1">Backbone.NotExist</validator>
          <validator type="log" dependingOption="za-31-3-1">Regional.Backbone.Multiple</validator>
        </validation>
        <validation id="3.1.2" description="The index.xml file must be valid " severity="Error">
          <validator type="log" dependingOption="za-31-3-1">Xml</validator>
          <validator type="log" dependingOption="za-31-3-1">LeafId.Invalid</validator>
          <validator type="log" dependingOption="za-31-3-1">ModifiedFile.IncorrectSyntax</validator>
        </validation>
      </validation>
      <validation id="3.2" description="3.2 MD5 Checksum">
        <validation id="3.2.1" description="Attribute checksum-type" severity="Error">
          <validator type="log" dependingOption="za-31-3-2">ChecksumType.Incorrect</validator>
        </validation>
        <validation id="3.2.2" description="MD5 Checksum " severity="Error">
          <validator type="log" dependingOption="za-31-3-2">Checksum.Failed</validator>
        </validation>
        <validation id="3.2.3" description="MD5 for Index file" severity="Error">
          <validator type="log" dependingOption="za-31-3-2">Index.Checksum.Failed</validator>
          <validator type="log" dependingOption="za-31-3-2">SubmissionChecksumFileName.Failed</validator>
          <validator type="log" dependingOption="za-31-3-2">SubmissionChecksum.Failed</validator>
        </validation>
      </validation>
      <validation id="3.3" description="3.3 References">
        <validation id="3.3.1" 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-31-3-3">InvalidSchemaOrDtdLocation</validator>
        </validation>
        <validation id="3.3.2" description="The files referenced by the cross reference (xlink:href) must exist " severity="Error">
          <validator type="log" dependingOption="za-31-3-3">HrefPointToFile.NotExist</validator>
        </validation>
        <validation id="3.3.3" description="Only relative references are being used" severity="Error">
          <validator type="log" dependingOption="za-31-3-3">ModifiedFileRelativePath</validator>
          <validator type="log" dependingOption="za-31-3-3">HrefRelativePath</validator>
          <validator type="log" dependingOption="za-31-3-3">Attribute.InvalidCharacters</validator>
        </validation>
        <validation id="3.3.4" description="References to targets outside Application" severity="Information">
          <validator type="log" dependingOption="za-31-3-3">References.FilesOutsideApplication</validator>
        </validation>
        <validation id="3.3.5" description="References to targets outside Sequence" severity="Information">
          <validator type="log" dependingOption="za-31-3-3">References.FilesOutsideSequence</validator>
        </validation>
      </validation>
      <validation id="3.4" description="3.4 Heading Elements, Leaves and Node Extensions">
        <validation id="3.4.1" description="m1-administrative element must exist" severity="Error">
          <validator type="log" dependingOption="za-31-3-4">ICH.M1Root.NotExist</validator>
        </validation>
        <validation id="3.4.2" description="Element must have leaf" severity="Error">
          <validator type="log" dependingOption="za-31-3-4">FolderEmpty</validator>
        </validation>
        <validation id="3.4.3" description="Required Attribute value checks" severity="Error">
          <validator type="log" dependingOption="za-31-3-4">ICHMetadataAttribute.EmptyValue</validator>
        </validation>
        <validation id="3.4.4" description="Optional Attribute value checks" severity="Warning">
          <validator type="log" dependingOption="za-31-3-4">ICHMetadataAttribute.EmptyValue.Optional</validator>
        </validation>
        <validation id="3.4.5" description="Leaf title must not be empty" severity="Error">
          <validator type="log" dependingOption="za-31-3-4">Leaf.Title.Empty</validator>
        </validation>
        <validation id="3.4.6" description="Node Extensions are appropriately placed" severity="Warning">
          <validator type="log" dependingOption="za-31-3-4">NodeExtensionAppropriatelyPlaced</validator>
        </validation>
        <validation id="3.4.7" description="Node Extension title must not be empty" severity="Error">
          <validator type="log" dependingOption="za-31-3-4">NodeExtension.Title.Empty</validator>
        </validation>
        <validation id="3.4.8" description="Node Extension exists for all Clinical Studies" severity="Warning">
          <validator type="log" dependingOption="za-31-3-4">NodeExtensionsInModule53</validator>
        </validation>
        <validation id="3.4.9" description="Node Extension naming convention for content provided in 5.3.6" severity="Warning">
          <validator type="log" dependingOption="za-31-3-4">NodeExtensionsInModule536</validator>
        </validation>
        <validation id="3.4.10" description="Node Extension elements in 3.2.R" severity="Warning">
          <validator type="log" dependingOption="za-31-3-4">LeafElementsIn32R</validator>
        </validation>
        <validation id="3.4.11" description="Node Extension naming convention for content provided in 3.2.R" severity="Warning">
          <validator type="log" dependingOption="za-31-3-4">NamingConventionNodeExtensions</validator>
        </validation>
        <validation id="3.4.12" description="CEP/CPQ Naming Convention" severity="Warning">
          <validator type="log" dependingOption="za-31-3-4">LeafTitleInModule32R3</validator>
        </validation>
      </validation>
      <validation id="3.5" description="3.5 Life Cycle Management">
        <validation id="3.5.1" description="Multiple operations on the same document in the same Sequence are not allowed" severity="Error">
          <validator type="log" dependingOption="za-31-3-5">MultipleOperationOnSingleLeaf</validator>
        </validation>
        <validation id="3.5.2" description="Leaf operation attribute" severity="Error">
          <validator type="log" dependingOption="za-31-3-5">ModifiedFile.Unverifiable</validator>
          <validator type="log" dependingOption="za-31-3-5">DeletedLeaf.Href.NotBlank</validator>
          <validator type="log" dependingOption="za-31-3-5">BlankHref</validator>
          <validator type="log" dependingOption="za-31-3-5">OperationNew</validator>
          <validator type="log" dependingOption="za-31-3-5">ModifiedFileExist</validator>
        </validation>
        <validation id="3.5.3" description="Modified file existence" severity="Error">
          <validator type="log" dependingOption="za-31-3-5">ModifiedFileNotFound</validator>
        </validation>
        <validation id="3.5.4" description="Do not relocate Content" severity="Error">
          <validator type="log" dependingOption="za-31-3-5">ModifiedFile.NotInSameSection</validator>
          <validator type="log" dependingOption="za-31-3-5">ModifiedFile.NotInSameNodeExtension</validator>
          <validator type="log" dependingOption="za-31-3-5">ModifiedFile.NotInSameNodeExtensionOrSection</validator>
        </validation>
        <validation id="3.5.5" description="Use of Append " severity="Error">
          <validator type="log" dependingOption="za-31-3-5">AppendOutsideSTF</validator>
        </validation>
        <validation id="3.5.6" description="Detect invalid lifecycle pattern: Append operations causing branches" severity="Error">
          <validator type="log" dependingOption="za-31-3-5">InvalidLifeCycleOperation.Append</validator>
          <validator type="log" dependingOption="za-31-3-5">InvalidLifeCycleOperation.Delete</validator>
          <validator type="log" dependingOption="za-31-3-5">InvalidLifeCycleOperation.Replace</validator>
        </validation>
        <validation id="3.5.7" description="Detect invalid lifecycle pattern: Delete operations causing branches" severity="Error">
          <validator type="log" dependingOption="za-31-3-5">InvalidLifeCycleOperation.Append</validator>
          <validator type="log" dependingOption="za-31-3-5">InvalidLifeCycleOperation.Delete</validator>
          <validator type="log" dependingOption="za-31-3-5">InvalidLifeCycleOperation.Replace</validator>
        </validation>
        <validation id="3.5.8" description="Detect invalid lifecycle pattern: Replace operations causing branches" severity="Error">
          <validator type="log" dependingOption="za-31-3-5">InvalidLifeCycleOperation.Append</validator>
          <validator type="log" dependingOption="za-31-3-5">InvalidLifeCycleOperation.Delete</validator>
          <validator type="log" dependingOption="za-31-3-5">InvalidLifeCycleOperation.Replace</validator>
        </validation>
        <validation id="3.5.9" description="Detect invalid lifecycle pattern: Operation on deleted leaf content" severity="Error">
          <validator type="log" dependingOption="za-31-3-5">InvalidLifeCycleOperation.MultipleDelete</validator>
        </validation>
        <validation id="3.5.10" description="Detect invalid lifecycle pattern: Append operations not appending to most recent STF leaf" severity="Error">
          <validator type="log" dependingOption="za-31-3-5">Stf.AppendOperation</validator>
        </validation>
        <validation id="3.5.11" description="Replace should not provide content identical to the previous file" severity="Warning">
          <validator type="log" dependingOption="za-31-3-5">File.CompareContent</validator>
        </validation>
        <validation id="3.5.12" description="ICH File reuse" severity="Information">
          <validator type="log" dependingOption="za-31-3-5">Href.Reused</validator>
        </validation>
      </validation>
      <validation id="3.6" description="3.6 File Existence">
        <validation id="3.6.1" description="Missing Content in section 3.2.S" severity="Information">
          <validator type="log" dependingOption="za-31-3-6">SectionsMissingContentIn32S</validator>
        </validation>
        <validation id="3.6.2" description="Missing Content in section 3.2.P" severity="Information">
          <validator type="log" dependingOption="za-31-3-6">SectionsMissingContentIn32P</validator>
        </validation>
      </validation>
    </validation>
    <validation id="4" description="4 - South African Regional">
      <validation id="4.1" description="4.1 The regional.xml">
        <validation id="4.1.1" description="Module 1 (regional xml file) exists" severity="Error">
          <validator type="log" dependingOption="za-31-4-1">Backbone.NotExist</validator>
          <validator type="log" dependingOption="za-31-4-1">Regional.Backbone.Multiple</validator>
        </validation>
        <validation id="4.1.2" description="The regional backbone file must be valid." severity="Error">
          <validator type="log" dependingOption="za-31-4-1">Xml</validator>
          <validator type="log" dependingOption="za-31-4-1">LeafId.Invalid</validator>
        </validation>
      </validation>
      <validation id="4.2" description="4.2 MD5 Checksum">
        <validation id="4.2.1" description="MD5 Checksum" severity="Error">
          <validator type="log" dependingOption="za-31-4-2">Checksum.Failed</validator>
          <validator type="log" dependingOption="za-31-4-2">SubmissionChecksumFileName.Failed</validator>
        </validation>
        <validation id="4.2.2" description="Attribute checksum-type" severity="Error">
          <validator type="log" dependingOption="za-31-4-2">ChecksumType.Incorrect</validator>
        </validation>
        <validation id="4.2.3" description="HTML Rendition of Regional Backbone" severity="Information">
          <validator type="log" dependingOption="za-31-4-2">ChecksumInRegionlHtml</validator>
        </validation>
      </validation>
      <validation id="4.3" description="4.3 References">
        <validation id="4.3.1" description="The reference to the Schema in za-regional.xml is directed to the Schema provided in the util folder." severity="Error">
          <validator type="log" dependingOption="za-31-4-3">InvalidSchemaOrDtdLocation</validator>
        </validation>
        <validation id="4.3.2" description="The files referenced by the cross reference must exist" severity="Error">
          <validator type="log" dependingOption="za-31-4-3">HrefPointToFile.NotExist</validator>
        </validation>
        <validation id="4.3.3" description="Only relative references are being used" severity="Error">
          <validator type="log" dependingOption="za-31-4-3">ModifiedFileRelativePath</validator>
          <validator type="log" dependingOption="za-31-4-3">HrefRelativePath</validator>
          <validator type="log" dependingOption="za-31-4-3">Attribute.InvalidCharacters</validator>
        </validation>
        <validation id="4.3.4" description="References to targets outside Application" severity="Information">
          <validator type="log" dependingOption="za-31-4-3">References.FilesOutsideApplication</validator>
        </validation>
        <validation id="4.3.5" description="References to targets outside Sequence" severity="Information">
          <validator type="log" dependingOption="za-31-4-3">References.FilesOutsideSequence</validator>
        </validation>
      </validation>
      <validation id="4.4" description="4.4 Heading Elements, Leaves and Node Extensions">
        <validation id="4.4.1" description="Element must have leaf" severity="Error">
          <validator type="log" dependingOption="za-31-4-4">FolderEmpty</validator>
        </validation>
        <validation id="4.4.2" description="Leaf title must not be empty" severity="Error">
          <validator type="log" dependingOption="za-31-4-4">Leaf.Title.Empty</validator>
        </validation>
        <validation id="4.4.3" description="Node Extensions are appropriately placed" severity="Warning">
          <validator type="log" dependingOption="za-31-4-4">NotAllowExtensionM1</validator>
        </validation>
        <validation id="4.4.4" description="Node Extension title must not be empty" severity="Error">
          <validator type="log" dependingOption="za-31-4-4">NodeExtension.Title.Empty</validator>
        </validation>
      </validation>
      <validation id="4.5" description="4.5 Life Cycle Management">
        <validation id="4.5.1" description="Multiple operations on same document in same Sequence are not allowed" severity="Error">
          <validator type="log" dependingOption="za-31-4-5">MultipleOperationOnSingleLeaf</validator>
        </validation>
        <validation id="4.5.2" description="Leaf operations" severity="Error">
          <validator type="log" dependingOption="za-31-4-5">ModifiedFile.Unverifiable</validator>
          <validator type="log" dependingOption="za-31-4-5">DeletedLeaf.Href.NotBlank</validator>
          <validator type="log" dependingOption="za-31-4-5">BlankHref</validator>
          <validator type="log" dependingOption="za-31-4-5">OperationNew</validator>
          <validator type="log" dependingOption="za-31-4-5">ModifiedFileExist</validator>
        </validation>
        <validation id="4.5.3" description="Modified file existence" severity="Error">
          <validator type="log" dependingOption="za-31-4-5">ModifiedFileNotFound</validator>
        </validation>
        <validation id="4.5.4" description="Do not relocate Content" severity="Error">
          <validator type="log" dependingOption="za-31-4-5">ModifiedFile.NotInSameSection</validator>
          <validator type="log" dependingOption="za-31-4-5">ModifiedFile.NotInSameNodeExtension</validator>
          <validator type="log" dependingOption="za-31-4-5">ModifiedFile.NotInSameNodeExtensionOrSection</validator>
        </validation>
        <validation id="4.5.5" description="Use of Append " severity="Error">
          <validator type="log" dependingOption="za-31-4-5">AppendOutsideSTF</validator>
        </validation>
        <validation id="4.5.6" description="Detect invalid lifecycle pattern: Append operations causing branches" severity="Error">
          <validator type="log" dependingOption="za-31-4-5">InvalidLifeCycleOperation.Append</validator>
          <validator type="log" dependingOption="za-31-4-5">InvalidLifeCycleOperation.Delete</validator>
          <validator type="log" dependingOption="za-31-4-5">InvalidLifeCycleOperation.Replace</validator>
        </validation>
        <validation id="4.5.7" description="Detect invalid lifecycle pattern: Delete operations causing branches" severity="Error">
          <validator type="log" dependingOption="za-31-4-5">InvalidLifeCycleOperation.Append</validator>
          <validator type="log" dependingOption="za-31-4-5">InvalidLifeCycleOperation.Delete</validator>
          <validator type="log" dependingOption="za-31-4-5">InvalidLifeCycleOperation.Replace</validator>
        </validation>
        <validation id="4.5.8" description="Detect invalid lifecycle pattern: Replace operations causing branches" severity="Error">
          <validator type="log" dependingOption="za-31-4-5">InvalidLifeCycleOperation.Append</validator>
          <validator type="log" dependingOption="za-31-4-5">InvalidLifeCycleOperation.Delete</validator>
          <validator type="log" dependingOption="za-31-4-5">InvalidLifeCycleOperation.Replace</validator>
        </validation>
        <validation id="4.5.9" description="Detect invalid lifecycle pattern: Operation on deleted leaf content" severity="Error">
          <validator type="log" dependingOption="za-31-4-5">InvalidLifeCycleOperation.MultipleDelete</validator>
        </validation>
        <validation id="4.5.10" description="Replace should not provide content identical to the previous file" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">File.CompareContent</validator>
        </validation>
        <validation id="4.5.11" description="Regional File Reuse" severity="Information">
          <validator type="log" dependingOption="za-31-4-5">Href.Reused</validator>
        </validation>
        <validation id="4.5.12" description="Letter of Application operation attribute" severity="Error">
          <validator type="log" dependingOption="za-31-4-5">Operation.InvalidNewOperation</validator>
          <validator type="log" dependingOption="za-31-4-5">Operation.ApplicationForm</validator>
          <validator type="log" dependingOption="za-31-4-5">Operation.CoverLetter</validator>
        </validation>
        <validation id="4.5.13" description="Note to Evaluator operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.InvalidNewOperation.NoteToEval</validator>
        </validation>
        <validation id="4.5.14" description="Correspondence from SAHPRA operation Attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.InvalidNewOperation.Correspondence</validator>
        </validation>
        <validation id="4.5.15" description="Response to SAHPRA Request operation Attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.InvalidNewOperation.Response</validator>
        </validation>
        <validation id="4.5.16" description="Application Form operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.InvalidNewOperation</validator>
          <validator type="log" dependingOption="za-31-4-5">Operation.ApplicationForm</validator>
        </validation>
        <validation id="4.5.17" description="Proof of Payment operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.InvalidNewOperation.ProofAndOthers</validator>
        </validation>
        <validation id="4.5.18" description="Electronic Copy Declaration operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.InvalidNewOperation.ProofAndOthers</validator>
        </validation>
        <validation id="4.5.19" description="Validation Templates (Checklists) operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.InvalidNewOperation.ValTemp</validator>
        </validation>
        <validation id="4.5.20" description="Tabular Schedule of Amendments operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.InvalidNewOperation.ProofAndOthers</validator>
        </validation>
        <validation id="4.5.21" description="Professional Information (PI) operation attribute (including all subnodes)" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.22" description="Reference Product - Local operation attribute (including all subnodes)" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.23" description="Patient Information Leaflet operation attribute (including all subnodes)" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.24" description="Labels operation attribute (including all subnodes)" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.25" description="Foreign Prescribing and Patient Information operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.26" description="Artwork and Pictures of Samples operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.27" description="Batch Manufacturing Record of the Sample operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.28" description="CoA of the Sample operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.29" description="Date of Last Inspection of each Site operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.30" description="Latest GMP Certificate or a Copy of the Appropriate Licence operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.31" description="Confirmation of Contract operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace.RiskManag</validator>
        </validation>
        <validation id="4.5.32" description="SAPC Registration operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.33" description="Inspection Flow Diagram operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.34" description="Organogram operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.35" description="Risk Management Plan operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
        <validation id="4.5.36" description="Tabulated List of Foreign Regulatory Status operation attribute" severity="Warning">
          <validator type="log" dependingOption="za-31-4-5">Operation.SubLeafInvalidReplace</validator>
        </validation>
      </validation>
      <validation id="4.6" description="4.6 File Existence">
        <validation id="4.6.1" description="1.0.1 Letter of Application must exist" severity="Error">
          <validator type="log" dependingOption="za-31-4-6">InvalidLetterOfApplication</validator>
        </validation>
        <validation id="4.6.2" description="1.0.4 Response to Input Request must exist if the Sequence Type is 'Response'" severity="Error">
          <validator type="log" dependingOption="za-31-4-6">ResponseDocForResponseType</validator>
        </validation>
        <validation id="4.6.3" description="1.2.1 Application Form must exist" severity="Error">
          <validator type="log" dependingOption="za-31-4-6">ApplicationForm.NotExist</validator>
        </validation>
        <validation id="4.6.4" description="1.2.2.4 Electronic Copy Declaration must exist" severity="Error">
          <validator type="log" dependingOption="za-31-4-6">ElectronicCopyDeclaration.NotExist</validator>
        </validation>
        <validation id="4.6.5" description="1.2.5 Validation Template must exist" severity="Error">
          <validator type="log" dependingOption="za-31-4-6">ValidationTemplate.NotExist</validator>
        </validation>
        <validation id="4.6.6" description="1.5.2.1 Tabulated Schedule of Amendments must exist" severity="Warning">
          <validator type="log" dependingOption="za-31-4-6">AmendmentDocument.NotExist</validator>
        </validation>
        <validation id="4.6.7" description="Provide New Source Files" severity="Warning">
          <validator type="log" dependingOption="za-31-4-6">PdfSourceOperationMismatchError.New</validator>
        </validation>
        <validation id="4.6.8" description="Provide Replaced Source Files" severity="Warning">
          <validator type="log" dependingOption="za-31-4-6">PdfSourceOperationMismatchError.Replace</validator>
        </validation>
        <validation id="4.6.9" description="Delete File where Source Files are required" severity="Warning">
          <validator type="log" dependingOption="za-31-4-6">PdfSourceOperationMismatchError.Delete</validator>
        </validation>
        <validation id="4.6.10" description="Provide at most ONE document per sequence per the SAHPRA M1 Granularity Annex " severity="Warning">
          <validator type="log" dependingOption="za-31-4-6">MultipleFilesInSectionError</validator>
        </validation>
      </validation>
      <validation id="4.7" description="4.7 - Envelope">
        <validation id="4.7.1a" description="Envelope: application" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.Application</validator>
        </validation>
        <validation id="4.7.1b" description="Envelope: application (Attribute Code Validity)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.ApplicationCodeVersion</validator>
        </validation>
        <validation id="4.7.2a" description="Envelope: application-id" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.AppId</validator>
        </validation>
        <validation id="4.7.2b" description="Envelope: application-id is the same as the Application folder" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.AppIdFolder</validator>
        </validation>
        <validation id="4.7.3" description="Envelope: application-number" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.AppNumber</validator>
        </validation>
        <validation id="4.7.4" description="Envelope: proprietary-name" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.ProName</validator>
        </validation>
        <validation id="4.7.5" description="Envelope: dosage-form" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.DosageForm</validator>
        </validation>
        <validation id="4.7.6" description="Envelope: inn" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.Inn</validator>
        </validation>
        <validation id="4.7.7a" description="Envelope: apimf-number" severity="Information">
          <validator type="log" dependingOption="za-31-4-7">Envelope.ApimfNumberSection</validator>
        </validation>
        <validation id="4.7.8a" description="Envelope: pmf-number" severity="Warning">
          <validator type="log" dependingOption="za-31-4-7">Envelope.PmfNumber</validator>
        </validation>
        <validation id="4.7.8b" description="Envelope: pmf-number provided when PMF content included" severity="Warning">
          <validator type="log" dependingOption="za-31-4-7">Envelope.PmfNumberSection</validator>
        </validation>
        <validation id="4.7.9a" description="Envelope: vamf-number" severity="Warning">
          <validator type="log" dependingOption="za-31-4-7">Envelope.VamfNumberSectionA</validator>
        </validation>
        <validation id="4.7.9b" description="Envelope: vamf-number provided when VAMF content included" severity="Warning">
          <validator type="log" dependingOption="za-31-4-7">Envelope.VamfNumberSectionB</validator>
        </validation>
        <validation id="4.7.10" description="Envelope: smf-number" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.SmfNumber</validator>
        </validation>
        <validation id="4.7.11a" description="Envelope: submission" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.Submission</validator>
        </validation>
        <validation id="4.7.11b" description="Envelope: submission (Attribute Code Validity)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.SubmissionCodeVersion</validator>
        </validation>
        <validation id="4.7.11c" description="Envelope: submission (Multiple Submissions in eCTD)" severity="Information">
          <validator type="log" dependingOption="za-31-4-7">Envelope.MultipleSubmissionInfo</validator>
        </validation>
        <validation id="4.7.11d" description="Envelope: submission (Submission Combination Validity)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.SubmissionCombine</validator>
        </validation>
        <validation id="4.7.11e" description="Envelope: submission (Application Withdrawal not allowed as only sequence of an Application)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.SubmissionWithDraw</validator>
        </validation>
        <validation id="4.7.12a" description="Envelope: evaluation-path" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.EvaluationPath.Invalid</validator>
        </validation>
        <validation id="4.7.12b" description="Envelope: evaluation-path (Attribute Code Validity)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.EvaluationPath.InvalidCode</validator>
        </validation>
        <validation id="4.7.12c" description="Envelope: evaluation-pathway (Multiple Submissions)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.EvaluationPath.NotTheSame</validator>
        </validation>
        <validation id="4.7.13a" description="Envelope: submission-lead" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.SubmissionLead.Invalid</validator>
        </validation>
        <validation id="4.7.13b" description="Envelope: submission-lead (Attribute Code Validity)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.SubmissionLead.InvalidCode</validator>
        </validation>
        <validation id="4.7.14" description="Envelope: submission-number" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.SubmissionNumber.Invalid</validator>
        </validation>
        <validation id="4.7.15a" description="Envelope: sequence" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.Sequence.Invalid</validator>
        </validation>
        <validation id="4.7.15b" description="Envelope: sequence (Attribute Code Validity)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.SequenceType.InvalidCode</validator>
        </validation>
        <validation id="4.7.16" description="Envelope: sequence-description" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.SequenceDes.Invalid</validator>
        </validation>
        <validation id="4.7.17a" description="Envelope: sequence-date" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.SequenceDate.Invalid</validator>
        </validation>
        <validation id="4.7.17b" description="Envelope: sequence-date (Not outdated)" severity="Warning">
          <validator type="log" dependingOption="za-31-4-7">Envelope.SequenceDate.OverLimit</validator>
        </validation>
        <validation id="4.7.18a" description="Envelope: sequence-number" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">UniqueSequenceNumber</validator>
          <validator type="log" dependingOption="za-31-4-7">SameSequenceNumber</validator>
        </validation>
        <validation id="4.7.18b" description="Envelope: sequence-number (Must match Sequence Folder name)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">SequenceNumberNotMatch</validator>
        </validation>
        <validation id="4.7.19a" description="Envelope: related-sequence-number" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">UniqueRelatedSequenceNumber</validator>
        </validation>
        <validation id="4.7.19b" description="Envelope: related-sequence-number (Number value)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">RelatedSequenceNumber.Lower</validator>
        </validation>
        <validation id="4.7.19c" description="Envelope: related-sequence-number (Sequence Type 'Initial' references itself)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">RelatedSequenceReferItSelf</validator>
        </validation>
        <validation id="4.7.20a" description="Envelope: multiple-applications" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.MultipleApp.Invalid</validator>
        </validation>
        <validation id="4.7.20b" description="Envelope: multiple-applications (Attribute Values)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.MultipleApp.Distinct</validator>
        </validation>
        <validation id="4.7.21a" description="Envelope: contact" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.Contact.Invalid</validator>
        </validation>
        <validation id="4.7.21b" description="Envelope: contact (Attribute Code Validity)" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.Contact.InvalidCode</validator>
        </validation>
        <validation id="4.7.22" description="Envelope: contact-name" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.ContactName.Invalid</validator>
        </validation>
        <validation id="4.7.23" description="Envelope: contact-email" severity="Error">
          <validator type="log" dependingOption="za-31-4-7">Envelope.ContactEmail.Invalid</validator>
        </validation>
      </validation>
      <validation id="4.8" description="4.8 - Content">
        <validation id="4.8.1" description="Required documents and prohibited documents" severity="Error">
          <validator type="log" dependingOption="za-31-4-8">RequiredFile.NotExist</validator>
          <validator type="log" dependingOption="za-31-4-8">ExcludedFile.Exist</validator>
        </validation>
        <validation id="4.8.2" description="Expected documents and documents that should not be provided" severity="Warning">
          <validator type="log" dependingOption="za-31-4-8">ExpectedFile.NotExist</validator>
          <validator type="log" dependingOption="za-31-4-8">ExcludedFile.Exist.Warning</validator>
        </validation>
        <validation id="4.8.3" description="Possible Documents" severity="Information">
          <validator type="log" dependingOption="za-31-4-8">PossibleFile.NotExist</validator>
        </validation>
        <validation id="4.8.4" description="Content Checklist" severity="Information">
          <validator type="log" dependingOption="za-31-4-8">ContentChecklist</validator>
        </validation>
      </validation>
    </validation>
    <validation id="5" description="5 - STF">
      <validation id="5.1" description="5.1 References">
        <validation id="5.1.1" description="Check index reference " severity="Error">
          <validator type="log" dependingOption="za-31-5-1">Stf.LeafId.NotExist</validator>
        </validation>
        <validation id="5.1.2" description="Check index reference (title match)" severity="Warning">
          <validator type="log" dependingOption="za-31-5-1">Stf.DocContent.Title.NotMatch</validator>
        </validation>
        <validation id="5.1.3" description="No backslash in xlink:href reference" severity="Error">
          <validator type="log" dependingOption="za-31-5-1">StfHrefHasBackslashes</validator>
        </validation>
        <validation id="5.1.4" description="STF leaf elements must reference other STF leaf upon append" severity="Error">
          <validator type="log" dependingOption="za-31-5-1">Stf.Append.ReferenceOtherStf</validator>
        </validation>
        <validation id="5.1.5" description="STF cannot reference another STF" severity="Warning">
          <validator type="log" dependingOption="za-31-5-1">Stf.ReferenceStf</validator>
        </validation>
        <validation id="5.1.6" description="STF files must reference at least one leaf" severity="Warning">
          <validator type="log" dependingOption="za-31-5-1">Stf.NotHasReferencedLeaf</validator>
        </validation>
        <validation id="5.1.7" description="Cumulative STF files are not allowed" severity="Error">
          <validator type="log" dependingOption="za-31-5-1">Stf.Cumulative</validator>
        </validation>
      </validation>
      <validation id="5.2" description="5.2 Heading Elements, Leaves and Node Extensions">
        <validation id="5.2.1" description="Content Blocks are not accepted" severity="Warning">
          <validator type="log" dependingOption="za-31-5-2">Stf.ContentBlock.NotAccepted</validator>
        </validation>
        <validation id="5.2.2" description="Study Identifier category must not be empty" severity="Warning">
          <validator type="log" dependingOption="za-31-5-2">Stf.Categories.Empty</validator>
        </validation>
        <validation id="5.2.3" description="Study Identifier study-id must not be empty" severity="Warning">
          <validator type="log" dependingOption="za-31-5-2">Stf.StudyId.Empty</validator>
        </validation>
        <validation id="5.2.4" description="Study Identifier title must not be empty" severity="Warning">
          <validator type="log" dependingOption="za-31-5-2">Stf.Title.Empty</validator>
        </validation>
        <validation id="5.2.5" description="Categories and file tags" severity="Warning">
          <validator type="log" dependingOption="za-31-5-2">Stf.Category.NotSupported</validator>
          <validator type="log" dependingOption="za-31-5-2">Stf.FileTag.NotSupported</validator>
          <validator type="log" dependingOption="za-31-5-2">Stf.Property.NotSupported</validator>
        </validation>
        <validation id="5.2.6" description="Category information must be provided for certain STFs" severity="Warning">
          <validator type="log" dependingOption="za-31-5-2">Stf.Category.Missing</validator>
        </validation>
        <validation id="5.2.7" description="Invalid STF TOC location" severity="Warning">
          <validator type="log" dependingOption="za-31-5-2">Stf.WrongSection</validator>
        </validation>
        <validation id="5.2.8" description="STF doc-content file tag count" severity="Warning">
          <validator type="log" dependingOption="za-31-5-2">Stf.FileTag.NotExist1</validator>
        </validation>
      </validation>
      <validation id="5.3" description="5.3 Life Cycle Management">
        <validation id="5.3.1" description="Study ID for STF must remain constant" severity="Warning">
          <validator type="log" dependingOption="za-31-5-3">Stf.StudyId.NotMatch</validator>
        </validation>
      </validation>
      <validation id="5.4" description="5.4 STF Information">
        <validation id="5.4.1" description="Informational output about the number and total size of non E3 documents." severity="Information">
          <validator type="log" dependingOption="za-31-5-4">Stf.E3Info</validator>
        </validation>
      </validation>
    </validation>
    <validation id="6" description="6 - PDF Analysis">
      <validation id="6.1" description="6.1 PDF Readability">
        <validation id="6.1.1" description="PDF documents must be readable" severity="Error">
          <validator type="log" dependingOption="za-31-6-1">Pdf.Failed</validator>
        </validation>
      </validation>
      <validation id="6.2" description="6.2 Bookmarks">
        <validation id="6.2.1" description="Bookmarks must be relative" severity="Warning">
          <validator type="log" dependingOption="za-31-6-2">AbsolutePathBookmarkInPdf</validator>
        </validation>
        <validation id="6.2.2" description="Bookmarks with web or email destinations" severity="Warning">
          <validator type="log" dependingOption="za-31-6-2">ExternalBookmark</validator>
        </validation>
        <validation id="6.2.3" description="Bookmarks with destinations outside repository root folder are not allowed" severity="Warning">
          <validator type="log" dependingOption="za-31-6-2">PdfExternalDestinationBookmark</validator>
        </validation>
        <validation id="6.2.4" description="Bookmarks must not have multiple actions" severity="Warning">
          <validator type="log" dependingOption="za-31-6-2">PdfMultipleActionBookmark</validator>
        </validation>
        <validation id="6.2.5" description="Bookmarks must not be inactive" severity="Warning">
          <validator type="log" dependingOption="za-31-6-2">PdfInactiveBookmark</validator>
        </validation>
        <validation id="6.2.6" description="Bookmarks must not be broken" severity="Warning">
          <validator type="log" dependingOption="za-31-6-2">BookmarkBrokenLinkInPdf</validator>
        </validation>
        <validation id="6.2.7" description="Bookmarks must be 'Inherit Zoom'" severity="Warning">
          <validator type="log" dependingOption="za-31-6-2">Bookmark.Pdf.InvalidMagnification</validator>
        </validation>
        <validation id="6.2.8" description="Bookmarks should exist in all larger documents" severity="Warning">
          <validator type="log" dependingOption="za-31-6-2">Pdf.Bookmark</validator>
        </validation>
        <validation id="6.2.9" description="Bookmarks meet ISO 32000-1:2008 requirements" severity="Warning">
          <validator type="log" dependingOption="za-31-6-2">PdfBackslashBookmark</validator>
        </validation>
      </validation>
    </validation>
    <validation id="6.3" description="6.3 Hyperlinks">
      <validation id="6.3.1" description="Hyperlinks must be relative" severity="Warning">
        <validator type="log" dependingOption="za-31-6-3">AbsolutePathInPdf</validator>
      </validation>
      <validation id="6.3.2" description="Hyperlinks with destinations outside repository root folder are not allowed" severity="Warning">
        <validator type="log" dependingOption="za-31-6-3">PdfExternalDestinationHyperLink</validator>
      </validation>
      <validation id="6.3.3" description="Hyperlinks must not have multiple actions" severity="Warning">
        <validator type="log" dependingOption="za-31-6-3">PdfMultipleAction</validator>
      </validation>
      <validation id="6.3.4" description="Hyperlinks must not be inactive" severity="Warning">
        <validator type="log" dependingOption="za-31-6-3">PdfInactiveBookmarkHyperlink</validator>
      </validation>
      <validation id="6.3.5" description="Hyperlinks must not be broken" severity="Warning">
        <validator type="log" dependingOption="za-31-6-3">BrokenLinkInPdf</validator>
      </validation>
      <validation id="6.3.6" description="Hyperlinks must 'Inherit Zoom'" severity="Warning">
        <validator type="log" dependingOption="za-31-6-3">Pdf.InvalidMagnification</validator>
      </validation>
      <validation id="6.3.7" description="Hyperlinks must exist in the Validation Templates" severity="Warning">
        <validator type="log" dependingOption="za-31-6-3">SectionInValidationTemplate</validator>
      </validation>
      <validation id="6.3.8" description="Hyperlinks must exist in Patient Information Leaflet to the Professional Information" severity="Warning">
        <validator type="log" dependingOption="za-31-6-3">CrossReferencePatientInformationLeaflet</validator>
      </validation>
      <validation id="6.3.9" description="Hyperlinks must exist in the Professional Information" severity="Warning">
        <validator type="log" dependingOption="za-31-6-3">ActualCrossReferencePackageInsert</validator>
      </validation>
      <validation id="6.3.10" description="Hyperlinks must exist in the Tabulated Schedule of Amendments" severity="Warning">
        <validator type="log" dependingOption="za-31-6-3">LinkToRelevantDocument</validator>
      </validation>
      <validation id="6.3.11" description="Hyperlinks meet ISO 32000-1:2008 requirements" severity="Warning">
        <validator type="log" dependingOption="za-31-6-3">PdfBackslash</validator>
      </validation>
      <validation id="6.3.12" description="Hyperlinks with web or email destinations" severity="Information">
        <validator type="log" dependingOption="za-31-6-3">Pdf.UseURLLink</validator>
      </validation>
    </validation>
    <validation id="6.4" description="6.4 PDF Properties">
      <validation id="6.4.1" description="PDF documents should not have any security settings " severity="Error">
        <validator type="log" dependingOption="za-31-6-4">PdfSecurity</validator>
      </validation>
      <validation id="6.4.2" description="PDF documents must not be password protected" severity="Error">
        <validator type="log" dependingOption="za-31-6-4">PdfSecurity</validator>
      </validation>
      <validation id="6.4.3" description="PDF version must be correct" severity="Warning">
        <validator type="log" dependingOption="za-31-6-4">Pdf.UnsupportedPdfVersion</validator>
      </validation>
      <validation id="6.4.4" description="PDF documents with attachments are not allowed" severity="Warning">
        <validator type="log" dependingOption="za-31-6-4">PdfAttachmentDetected</validator>
      </validation>
      <validation id="6.4.5" description="PDF initial view must be correct" severity="Warning">
        <validator type="log" dependingOption="za-31-6-4">Pdf.InvalidInitialView.Bookmark</validator>
        <validator type="log" dependingOption="za-31-6-4">InvalidPageModeWhenNoBookmark</validator>
        <validator type="log" dependingOption="za-31-6-4">Pdf.InvalidInitialView</validator>
      </validation>
      <validation id="6.4.6" description="PDF should have 'Fast Web Access' active" severity="Warning">
        <validator type="log" dependingOption="za-31-6-4">PdfFastWebAccess</validator>
      </validation>
      <validation id="6.4.7" description="PDF documents with annotations" severity="Warning">
        <validator type="log" dependingOption="za-31-6-4">PdfAnnotations</validator>
      </validation>
    </validation>
    <validation id="7" 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-31-7">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-31-7">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-31-7">Index.Checksum.InvalidFormat</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-31-7">SpecialFile.Size</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-31-7">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-31-7">RefOutsideSeqOrApp</validator>
        <validator type="log" dependingOption="za-31-7">RefOutsideSeqOrAppBookmark</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-31-7">PdfUnknownAction</validator>
        <validator type="log" dependingOption="za-31-7">PdfUnknownActionBookmark</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-31-7">PdfTotalNonRelativeBookmarks</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalWebEmailDestinationBookmarks</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalExternalDestinationBookmarks</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalUnknownActionBookmarks</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalInActiveBookmarks</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalBrokenBookmarks</validator>
        <validator type="log" dependingOption="za-31-7">PdfNumberOfBookmarksPerDocument</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalBookmarksInSubmission</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalNonRelativeHyperLinks</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalWebEmailDestinationHyperLinks</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalExternalDestinationHyperLinks</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalUnknownActionHyperLinks</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalInActiveHyperLinks</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalBrokenHyperLinks</validator>
        <validator type="log" dependingOption="za-31-7">PdfTotalHyperLinks</validator>
        <validator type="log" dependingOption="za-31-7">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="za-31-7">RefDocCorrupted</validator>
        <validator type="log" dependingOption="za-31-7">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="za-31-7">BlankLinkInPdf</validator>
        <validator type="log" dependingOption="za-31-7">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-31-7">Stf.PropertyBeforeFiletag</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-31-7">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-31-7">Stf.ReferencedMultiple</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-31-7">Stf.NotExist</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-31-7">Stf.Title.NotMatch</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-31-7">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-31-7">InvalidStfFileName</validator>
      </validation>
      <validation id="Recommended" description="Ensure that files in study sections are referenced by an STF" severity="Warning">
        <validator type="log" dependingOption="za-31-7">Stf.NotReferencedInSTF</validator>
      </validation>
      <validation id="Recommended" description="Ensure that valid STF DTD version (e.g. dtd-version = &#34;2.2&#34;) is referenced in the STF XML file" severity="Warning">
        <validator type="log" dependingOption="za-31-7">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-31-7">Leaf.Title.LeadsOrEndsWithSpace</validator>
        <validator type="log" dependingOption="za-31-7">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-31-7">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-31-7">IchDtdVersion</validator>
        <validator type="log" dependingOption="za-31-7">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-31-7">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-31-7">SpaceInAttribute</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-31-7">InvalidLeafOperation</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-31-7">InvalidLifeCyclePatternAppendOnAppend</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="za-31-7">NoneLeafElement</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-31-7">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-31-7">RegionalBackboneReferenced.WrongOperationAttribute</validator>
      </validation>
      <validation id="Recommended" description="Ensure that 'm1' folder must exist in the submission." severity="Warning">
        <validator type="log" dependingOption="za-31-7">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-31-7">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-31-7">SequenceNumber.IncreasesIncrementally</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. This is applicable for Module 4 and Module 5." severity="Warning">
        <validator type="log" dependingOption="za-31-7">Stf.FileName.Specific</validator>
      </validation>
    </validation>
  </validations>
</validationreport>