﻿<?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="CA Criteria">
    <validation id="1" description="A - GENERAL">
      <validation id="A01" description="Checks the sequence folder structure for any empty folders (folders without any files or subfolders)." severity="Error">
        <validator type="log" dependingOption="ca-51-1">EmptyFolder</validator>
      </validation>
      <validation id="A02" description="Checks the sequence folder structure for any files or folders the user does not have access permission to." severity="Error">
        <validator type="log" dependingOption="ca-51-1">AccessibleFileFolder</validator>
      </validation>
      <validation id="A03a" description="This rule's implementation checks for files that exceed the configured maximum size. Warning for PDF files between 150 MB and 200 MB. Warning for other file types larger than 100 MB (excluding SAS XPT)." severity="Warning">
        <validator type="log" dependingOption="ca-51-1">CA.LimitFileSize</validator>
      </validation>
      <validation id="A03b" description="This rule's implementation checks for files that exceed the configured maximum size&#xA;(Max. size: 200 MB for PDF, 1 GB for SAS XPT)." severity="Error">
        <validator type="log" dependingOption="ca-51-1">File.Size</validator>
        <validator type="log" dependingOption="ca-51-1">SpecialFile.Size</validator>
      </validation>
      <validation id="A05a" description="Checks the sequence folder name. Furthermore the rule will report a finding if the sequence seems to be the initial sequence for the application but its name is not 0000." severity="Error">
        <validator type="log" dependingOption="ca-51-1">InitialSequence.Invalid</validator>
      </validation>
      <validation id="A05b" description="Reports error if the validated sequence is not the highest in the application folder." severity="Error">
        <validator type="log" dependingOption="ca-51-1">CA.HighestSequence.Invalid</validator>
      </validation>
      <validation id="A06a" description="Identifies all ICH and regional index files found in the sequence folder. Incorrect or invalid index files will be reported as errors." severity="Error">
        <validator type="log" dependingOption="ca-51-1">RegionalDtdVersionPreceding</validator>
        <validator type="log" dependingOption="ca-51-1">Attribute.Invalid.InBackbone</validator>
        <validator type="log" dependingOption="ca-51-1">Stf.Category.Invalid</validator>
        <validator type="log" dependingOption="ca-51-1">AttributeMissing</validator>
        <validator type="log" dependingOption="ca-51-1">IchDtdVersionPreceding</validator>
      </validation>
      <validation id="A06b" description="Identifies all STF files found in the sequence folder. Invalid STF files will be reported as errors. STF files with an incorrect name will be also reported as errors" severity="Error">
        <validator type="log" dependingOption="ca-51-1">Stf.NotExist</validator>
        <validator type="log" dependingOption="ca-51-1">Stf.List</validator>
      </validation>
      <validation id="A07" description="Each subsequent transaction provided in the lifecycle of a dossier, must have a sequence number that is consecutively incremented by 1 number (for example 0000, 0001, 0002, 0003, and so on). Skipping numbers is not acceptable for sequence numbers. Validating a transaction with sequence number 0004 will report an error if sequence number 0003 does not exist (even if sequence 0004 does not have any reference to it)." severity="Error">
        <validator type="log" dependingOption="ca-51-1">SequenceNumber.IncreasesIncrementally</validator>
      </validation>
      <validation id="A09" description="Word document will be reported as corrupted or password protected if one or more of the following situations occur:&#xA;Document is corrupt or unreadable;Document has password protection;Document references an attached template located via http or https;Document is empty. Note: This rule applies only to Word version 2007 or later (.docx)." severity="Error">
        <validator type="log" dependingOption="ca-51-1">WordDocCorrupted</validator>
        <validator type="log" dependingOption="ca-51-1">WordDocEmpty</validator>
        <validator type="log" dependingOption="ca-51-1">WordDocPasswordProtected</validator>
        <validator type="log" dependingOption="ca-51-1">AttachedTemplateFromWeb</validator>
      </validation>
      <validation id="A10" description="This rule checks if the eCTD sequence that is being validated already exists in the eCTD dossier." severity="Error">
        <validator type="log" dependingOption="ca-51-1">SameSequenceNumber</validator>
      </validation>
    </validation>
    <validation id="2" description="B - PDF ANALYSIS">
      <validation id="B01" description="A PDF document will be reported as corrupt if one or more of the following situations occur: 1. The document cannot be opened because it is damaged.; 2. The document appears to have 0 pages.;3. The document appears to be an application form, but the form content cannot be read.;4. The document contains additional data (more than 1024 characters) after the last %%EOF (End Of File). An example of situation number (3) could be a document appearing to have 1 page only and the page contains the text phrase &quot;Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.&quot;" severity="Error">
        <validator type="log" dependingOption="ca-51-2">EndOfFile</validator>
        <validator type="log" dependingOption="ca-51-2">CA.CorruptOrUnreadablePdf</validator>
        <validator type="log" dependingOption="ca-51-2">Pdf.Failed</validator>
      </validation>
      <validation id="B02" description="Retrieves all non-relative bookmarks in PDF documents and prints the total count, including the broken ones." severity="Error">
        <validator type="log" dependingOption="ca-51-2">AbsolutePathBookmarkInPdf</validator>
      </validation>
      <validation id="B03a" description="Retrieves all web link bookmarks and e-mail bookmarks in PDF documents and prints the total count." severity="Error">
        <validator type="log" dependingOption="ca-51-2">ExternalBookmark</validator>
      </validation>
      <validation id="B03b" description="Retrieves all external bookmarks other than web links and e-mail links from PDF documents and prints the total count." severity="Error">
        <validator type="log" dependingOption="ca-51-2">PdfExternalDestinationBookmark</validator>
      </validation>
      <validation id="B04" description="Retrieves all inactive bookmarks in PDF documents and prints the total count." severity="Error">
        <validator type="log" dependingOption="ca-51-2">PdfInactiveBookmark</validator>
      </validation>
      <validation id="B06" description="Retrieves all broken inter-application bookmarks in PDF documents and prints the total count." severity="Error">
        <validator type="log" dependingOption="ca-51-2">BookmarkBrokenLinkInPdf</validator>
      </validation>
      <validation id="B08" description="Retrieves all broken intra-application bookmarks in PDF documents and prints the total count." severity="Error">
        <validator type="log" dependingOption="ca-51-2">BookmarkBrokenLinkInPdf</validator>
      </validation>
      <validation id="B10" description="Retrieves all broken intra-sequence bookmarks from PDF documents and prints the total count." severity="Error">
        <validator type="log" dependingOption="ca-51-2">BookmarkBrokenLinkInPdf</validator>
      </validation>
      <validation id="B11" description="Retrieves all unknown bookmarks (links that could not be identified or contain JavaScript code) from PDF documents and prints the total count." severity="Warning">
        <validator type="log" dependingOption="ca-51-2">PdfTotalUnknownAction</validator>
        <validator type="log" dependingOption="ca-51-2">PdfUnknownActionBookmark</validator>
      </validation>
      <validation id="B12" description="Reports the number of bookmarks per document and the total number of bookmarks in the sequence." severity="Information">
        <validator type="log" dependingOption="ca-51-2">PdfTotalWebEmailDestinationHyperLinks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalNonRelativeBookmarks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalInActiveHyperLinks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalWebEmailDestinationBookmarks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalHyperLinksInSubmission</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalNonRelativeHyperLinks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalExternalDestinationBookmarks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalExternalDestinationHyperLinks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalInActiveBookmarks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalBrokenHyperLinks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalHyperLinks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalUnknownActionBookmarks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalBrokenBookmarks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfNumberOfBookmarksPerDocument</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalBookmarksInSubmission</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalUnknownActionHyperLinks</validator>
      </validation>
      <validation id="B13" description="Retrieves all non-relative hyperlinks from PDF documents and prints the total count, including the broken ones." severity="Error">
        <validator type="log" dependingOption="ca-51-2">AbsolutePathInPdf</validator>
      </validation>
      <validation id="B14a" description="Retrieves all web links and e-mail links from PDF documents and prints the total count." severity="Error">
        <validator type="log" dependingOption="ca-51-2">Pdf.UseURLLink</validator>
      </validation>
      <validation id="B14b" description="Retrieves all external hyperlinks other than web links and e-mail links from PDF documents and prints the total count." severity="Error">
        <validator type="log" dependingOption="ca-51-2">PdfExternalDestinationHyperLink</validator>
      </validation>
      <validation id="B15" description="Retrieves all inactive hyperlinks from PDF documents and prints the total count." severity="Error">
        <validator type="log" dependingOption="ca-51-2">PdfInactiveBookmarkHyperlink</validator>
      </validation>
      <validation id="B17" description="Retrieves all broken inter-application hyperlinks from PDF documents and prints the total count." severity="Error">
        <validator type="log" dependingOption="ca-51-2">BrokenLinkInPdf</validator>
      </validation>
      <validation id="B19" description="Retrieves all broken intra-application hyperlinks from PDF documents and prints the total count." severity="Error">
        <validator type="log" dependingOption="ca-51-2">BrokenLinkInPdf</validator>
      </validation>
      <validation id="B21" description="Retrieves all broken intra-sequence hyperlinks from PDF documents and prints the total count." severity="Error">
        <validator type="log" dependingOption="ca-51-2">BrokenLinkInPdf</validator>
      </validation>
      <validation id="B22" description="Retrieves all unknown hyperlinks (links that could not be identified or contain JavaScript code) from PDF documents and prints the total count." severity="Warning">
        <validator type="log" dependingOption="ca-51-2">PdfTotalUnknownAction</validator>
        <validator type="log" dependingOption="ca-51-2">PdfUnknownAction</validator>
      </validation>
      <validation id="B23" description="Reports the number of hyperlinks per document and the total number of hyperlinks in the sequence." severity="Information">
        <validator type="log" dependingOption="ca-51-2">PdfTotalWebEmailDestinationHyperLinks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalNonRelativeBookmarks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalInActiveHyperLinks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalWebEmailDestinationBookmarks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalHyperLinksInSubmission</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalNonRelativeHyperLinks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalExternalDestinationBookmarks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalExternalDestinationHyperLinks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalInActiveBookmarks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalBrokenHyperLinks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalHyperLinks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalUnknownActionBookmarks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalBrokenBookmarks</validator>
        <validator type="log" dependingOption="ca-51-2">PdfNumberOfBookmarksPerDocument</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalBookmarksInSubmission</validator>
        <validator type="log" dependingOption="ca-51-2">PdfTotalUnknownActionHyperLinks</validator>
      </validation>
      <validation id="B24" description="Finds PDF documents with password protection." severity="Error">
        <validator type="log" dependingOption="ca-51-2">PdfOwnerPassword</validator>
        <validator type="log" dependingOption="ca-51-2">PdfSecurity</validator>
      </validation>
      <validation id="B25" description="Checks all PDF document versions against the list of allowed versions." severity="Warning">
        <validator type="log" dependingOption="ca-51-2">Pdf.UnsupportedPdfVersion</validator>
      </validation>
      <validation id="B32" description="Finds all documents with an owner password set, excluding Health Canada application forms regardless of their location in module 1 and literature references in subfolders: 33-lit-ref, 43-litref, 54-lit-ref." severity="Warning">
        <validator type="log" dependingOption="ca-51-2">PdfOwnerPassword</validator>
        <validator type="log" dependingOption="ca-51-2">PdfSecurity</validator>
      </validation>
      <validation id="B33" description="Finds all encrypted documents." severity="Information">
        <validator type="log" dependingOption="ca-51-2">PdfEncryptedDocument</validator>
      </validation>
      <validation id="B35" description="For all bookmarks, the named destination or destination page will be verified.&#xA;Non existing destinations will be reported (i.e. the destination file exists but the page does not)." severity="Error">
        <validator type="log" dependingOption="ca-51-2">BlankLinkInPdfBookmark</validator>
      </validation>
      <validation id="B36" description="Finds all bookmarks with multiple actions assigned." severity="Error">
        <validator type="log" dependingOption="ca-51-2">PdfMultipleActionBookmark</validator>
      </validation>
      <validation id="B37" description="For all hyperlinks, the named destination or destination page will be verified.&#xA;Non existing destinations will be reported (i.e. the destination file exists but the page does not)." severity="Error">
        <validator type="log" dependingOption="ca-51-2">BlankLinkInPdf</validator>
      </validation>
      <validation id="B38" description="Finds all hyperlinks with multiple actions assigned." severity="Error">
        <validator type="log" dependingOption="ca-51-2">PdfMultipleAction</validator>
      </validation>
      <validation id="B40" description="This rule is configured to detect attachments and portfolio documents found in PDF documents." severity="Error">
        <validator type="log" dependingOption="ca-51-2">PdfAttachmentDetected</validator>
      </validation>
      <validation id="B41" description="All bookmarks and hyperlinks should have a magnification setting of &quot;Inherit Zoom&quot;. This rule performs the corresponding checks for bookmarks." severity="Warning">
        <validator type="log" dependingOption="ca-51-2">Bookmark.Pdf.InvalidMagnification</validator>
      </validation>
      <validation id="B42" description="All bookmarks and hyperlinks should have a magnification setting of &quot;Inherit Zoom&quot;. This rule performs the corresponding checks for hyperlinks." severity="Warning">
        <validator type="log" dependingOption="ca-51-2">Pdf.InvalidMagnification</validator>
      </validation>
      <validation id="B43" description="Checks for PDF documents with an incorrect initial view. ICH eCTD Specification: Documents with bookmarks must show the bookmarks pane in their initial view. The Magnification and Page Layout should be set as &quot;default&quot;." severity="Warning">
        <validator type="log" dependingOption="ca-51-2">InvalidPageModeWhenNoBookmark</validator>
        <validator type="log" dependingOption="ca-51-2">Pdf.InvalidInitialView</validator>
        <validator type="log" dependingOption="ca-51-2">Pdf.InvalidInitialView.Bookmark</validator>
      </validation>
      <validation id="B44" description="PDF documents with more than 10 pages must have bookmarks. Excluded from this check are literature references in sections 3.3, 4.3, and 5.4; the life cycle management table; and Health Canada application forms regardless of their location in module 1." severity="Warning">
        <validator type="log" dependingOption="ca-51-2">Pdf.Bookmark</validator>
        <validator type="log" dependingOption="ca-51-2">Consistent.PageAndBookmark</validator>
      </validation>
      <validation id="B45" description="Finds all documents where printing is not allowed." severity="Error">
        <validator type="log" dependingOption="ca-51-2">PdfPrintingNotAllowed</validator>
      </validation>
      <validation id="B46" description="Finds all documents where copying the content is not allowed." severity="Error">
        <validator type="log" dependingOption="ca-51-2">PdfCopyingNotAllowed</validator>
      </validation>
      <validation id="B47" description="This rule checks for PDF files that contain, dynamic content (e.g., audio, video or special effects), or 3D content. Health Canada application forms are excluded from this check regardless of their location in module 1." severity="Error">
        <validator type="log" dependingOption="ca-51-2">Pdf.RestrictedContents</validator>
      </validation>
      <validation id="B48" description="This rule checks for PDF files that contain JavaScript. Health Canada application forms are excluded from this check regardless of their location in module 1." severity="Error">
        <validator type="log" dependingOption="ca-51-2">Pdf.RestrictedContents</validator>
      </validation>
      <validation id="B49" description="Document contains images only and is not text searchable." severity="Warning">
        <validator type="log" dependingOption="ca-51-2">PdfDocContainsNoText</validator>
      </validation>
    </validation>
    <validation id="3" description="C - REFERENCED FILES">
      <validation id="C01" description="Checks for broken links in submission files. Hyperlinks targeting files outside the application will be identified." severity="Error">
        <validator type="log" dependingOption="ca-51-3">References.FilesOutsideApplication</validator>
      </validation>
      <validation id="C02" description="Checks for broken links in submission files. Hyperlinks targeting files outside sequence will be identified." severity="Information">
        <validator type="log" dependingOption="ca-51-3">References.FilesOutsideSequence</validator>
      </validation>
      <validation id="C03" description="This check option refers to the current sequence. It will perform a general verification of the leaf life cycle properties in this sequence only (no deep history scanning). For leaf elements with operation &quot;new&quot;, the eValidator verifies that: modified file must not exist / title is given / href must exist.;For leaf elements with operation &quot;replace&quot;, the eValidator verifies that: modified file must exist / title is given / href must exist.;For leaf elements with operation &quot;append&quot;, the eValidator verifies that: modified file must exist / title is given / href must exist.;For leaf elements with operation &quot;delete&quot;, the eValidator verifies that: modified file must exist / title is not required / href must not exist.; The eValidator verifies that for initial submissions all leaf elements have the operation &quot;new&quot;. The eValidator checks modified files in LCM: leaf in previous sequence must exist. It also verifies that when the attribute &quot;modified-file&quot; has been used for a leaf document then the referenced document exists in the previous submission. It is recognized that this attribute is invalid when used for submission sequence number 0000.The eValidator checks that all files referenced in the backbone exist." severity="Error">
        <validator type="log" dependingOption="ca-51-3">ModifiedFileExist</validator>
        <validator type="log" dependingOption="ca-51-3">BlankHref</validator>
        <validator type="log" dependingOption="ca-51-3">LeafTitle.Required</validator>
        <validator type="log" dependingOption="ca-51-3">HrefPointToFile.NotExist</validator>
        <validator type="log" dependingOption="ca-51-3">ModifiedFileHasInvalidSequence</validator>
        <validator type="log" dependingOption="ca-51-3">Leaf.Failed</validator>
        <validator type="log" dependingOption="ca-51-3">HrefEmpty</validator>
        <validator type="log" dependingOption="ca-51-3">DeletedLeaf.Href.NotBlank</validator>
        <validator type="log" dependingOption="ca-51-3">ModifiedFileNotFound</validator>
        <validator type="log" dependingOption="ca-51-3">OperationNew</validator>
        <validator type="log" dependingOption="ca-51-3">ModifiedFile.Unverifiable</validator>
      </validation>
      <validation id="C04" description="The eValidator regenerates the MD5 checksums for all referenced files and compares the checksums to the values provided in the backbone file." severity="Error">
        <validator type="log" dependingOption="ca-51-3">Checksum.Failed</validator>
      </validation>
      <validation id="C05" description="Checks the syntax of all referenced file names (path length, illegal characters, etc.). The maximum path length is 230 characters." severity="Error">
        <validator type="log" dependingOption="ca-51-3">Path.Invalid</validator>
        <validator type="log" dependingOption="ca-51-3">Path.Case</validator>
        <validator type="log" dependingOption="ca-51-3">CA.LongFileName</validator>
        <validator type="log" dependingOption="ca-51-3">LongFileName</validator>
        <validator type="log" dependingOption="ca-51-3">LongPath</validator>
      </validation>
      <validation id="C06" description="The eValidator checks that only relative references (href and modified file) are used. Also, only forward slashes &quot;/&quot; are allowed (no backslashes). Do the file references in the index files (ICH, Regional, STF) use relative paths? Absolute (i.e. rooted) paths are not allowed." severity="Error">
        <validator type="log" dependingOption="ca-51-3">ModifiedFileRelativePath</validator>
        <validator type="log" dependingOption="ca-51-3">Attribute.InvalidCharacters</validator>
        <validator type="log" dependingOption="ca-51-3">HrefRelativePath</validator>
      </validation>
      <validation id="C07" description="Searches for files not referenced in an index file (ICH, Regional or STF)." severity="Error">
        <validator type="log" dependingOption="ca-51-3">SubmissionFolder.RedundantFiles</validator>
        <validator type="log" dependingOption="ca-51-3">M1Folder.RedundantFiles</validator>
        <validator type="log" dependingOption="ca-51-3">File.Extra</validator>
      </validation>
    </validation>
    <validation id="4" description="D - XML ANALYSIS">
      <validation id="D01" description="Rule compares the checksums of the DTD and schema against the following checksums:&#xA;ich-ectd-3-2.dtd: 1d6f631cc6b6357f0f4fe378e5f79a27;ca-regional-2-2-.xsd: ff564d6e69adebd9a9b4f274e65cf5f1;xml.xsd: 382b0a4f7529d2c5f7b0af0aa713b0a5;xlink.xsd: 52d1a3b8596e4fb61d3ec1cde24be16a;ich-stf-v2-2.dtd: 0972c10a4dadf3df5d2f41b2026a4a5c" severity="Error">
        <validator type="log" dependingOption="ca-51-4">DtdChecksumFailed</validator>
        <validator type="log" dependingOption="ca-51-4">IchChecksumFailed</validator>
        <validator type="log" dependingOption="ca-51-4">StfChecksumFailed</validator>
      </validation>
      <validation id="D02" description="The eValidator checks for &quot;node-extension&quot; elements being used and reports them for informational purposes." severity="Information">
        <validator type="log" dependingOption="ca-51-4">NodeExtension.Exist</validator>
      </validation>
      <validation id="D03" description="MD5 checksums for index files will be calculated and compared against the MD5 checksums provided in the MD5 text files (not case sensitive)." severity="Error">
        <validator type="log" dependingOption="ca-51-4">Index.Checksum.Failed</validator>
      </validation>
      <validation id="D04" description="Performs XML validation for ICH Backbone and Regional backbones. Uses the DTD or Schema given in the sequence number folder (util/dtd)." severity="Error">
        <validator type="log" dependingOption="ca-51-4">Xml</validator>
      </validation>
    </validation>
    <validation id="5" description="F - CA REGIONAL 2.2">
      <validation id="F01" description="Checks if referenced files have exactly one file extension." severity="Error">
        <validator type="log" dependingOption="ca-51-5">InconsistentExtensions</validator>
      </validation>
      <validation id="F03" description="Checks for elements not having any leaf child nodes. This only affects elements with a name that starts with 'm'." severity="Error">
        <validator type="log" dependingOption="ca-51-5">NoneLeafElement</validator>
      </validation>
      <validation id="F04" description="The sequence folder must have a subfolder m1 with a subfolder ca." severity="Error">
        <validator type="log" dependingOption="ca-51-5">CA.M1Region.NotExist</validator>
      </validation>
      <validation id="F05" description="The folder m1\ca must not have any subfolders." severity="Warning">
        <validator type="log" dependingOption="ca-51-5">CA.M1Region.NotExist</validator>
      </validation>
      <validation id="F06" description="For operations other than 'delete', all leafs must have a 'title' child. The title must be present." severity="Error">
        <validator type="log" dependingOption="ca-51-5">NodeExtension.Title.Empty</validator>
        <validator type="log" dependingOption="ca-51-5">Leaf.Title.Empty</validator>
        <validator type="log" dependingOption="ca-51-5">LeafTitle.DeleteLifeCycle</validator>
      </validation>
      <validation id="F07" description="The regional backbone ca-regional.xml file must exist in folder m1\ca." severity="Error">
        <validator type="log" dependingOption="ca-51-5">SchemaVersion</validator>
        <validator type="log" dependingOption="ca-51-5">Backbone.NotExist</validator>
        <validator type="log" dependingOption="ca-51-5">Regional.Backbone.Multiple</validator>
      </validation>
      <validation id="F08" description="The element value for the dossier-identifier must match the name of the parent folder of the sequence folder. And the dossier-identifier must start with the letter e or s." severity="Error">
        <validator type="log" dependingOption="ca-51-5">ApplicationNumberNotMatch</validator>
      </validation>
      <validation id="F09" description="Refer to the CA M1 guidance document for the list of valid values for the sequence-description element." severity="Error">
        <validator type="log" dependingOption="ca-51-5">AU.AUEnvelope.SequenceDescription.Value</validator>
      </validation>
      <validation id="F10" description="Cover letter should have 'new' operation attribute." severity="Warning">
        <validator type="log" dependingOption="ca-51-5">Operation.CoverLetter</validator>
        <validator type="log" dependingOption="ca-51-5">Operation.ApplicationForm</validator>
      </validation>
      <validation id="F11" description="Checks for documents in the regional backbone, which are used as modified-file more than once." severity="Error">
        <validator type="log" dependingOption="ca-51-5">MultipleOperationOnSingleLeaf</validator>
      </validation>
      <validation id="F12" description="Checks for file reuse scenarios (Same values for xlink:href used multiple times in the regional backbone for this sequence)." severity="Information">
        <validator type="log" dependingOption="ca-51-5">Href.Reused</validator>
      </validation>
      <validation id="F14" description="When replacing content, the new content should be different from the previous content. This check does not apply to image files provided in module 1." severity="Error">
        <validator type="log" dependingOption="ca-51-5">File.CompareContent</validator>
      </validation>
      <validation id="F15" description="Valid file extensions include: Documents:.pdf,.doc,.docx,.xls,.xlsx,.wpd,.ppt,.pptx;Images:.png,.gif,.svg,.jpg,.jpeg,.tif,.tiff,.bmp;Audio/Video:.wav,.mp3,.mp4,.wmv,.mov,.mpg,.mpeg;Coding Language:.xml;Data:.dat,.inf,.txt." severity="Error">
        <validator type="log" dependingOption="ca-51-5">FileType.Invalid</validator>
      </validation>
      <validation id="F17" description="Detect invalid life cycle pattern: Delete operations causing branches." severity="Error">
        <validator type="log" dependingOption="ca-51-5">InvalidLifeCycleOperation.Replace</validator>
        <validator type="log" dependingOption="ca-51-5">InvalidLifeCycleOperation.Append</validator>
        <validator type="log" dependingOption="ca-51-5">InvalidLifeCycleOperation.Delete</validator>
      </validation>
      <validation id="F18" description="Detect invalid life cycle pattern: Replace operations causing branches." severity="Error">
        <validator type="log" dependingOption="ca-51-5">InvalidLifeCycleOperation.Replace</validator>
        <validator type="log" dependingOption="ca-51-5">InvalidLifeCycleOperation.Append</validator>
        <validator type="log" dependingOption="ca-51-5">InvalidLifeCycleOperation.Delete</validator>
      </validation>
      <validation id="F19" description="Detect invalid life cycle pattern: Operation on deleted leaf content." severity="Error">
        <validator type="log" dependingOption="ca-51-5">InvalidLifeCycleOperation.MultipleDelete</validator>
      </validation>
      <validation id="F21" description="The value of the sequence-number element must match the sequence folder name." severity="Error">
        <validator type="log" dependingOption="ca-51-5">SequenceNumberNotMatch</validator>
        <validator type="log" dependingOption="ca-51-5">SequenceNumberNumeric</validator>
      </validation>
      <validation id="F22" description="The operation attribute for this leaf element must be “new” when provided for the first time, and “replace”/ “delete” whenever referenced again as part of a subsequent transaction." severity="Error">
        <validator type="log" dependingOption="ca-51-5">CA.LifecycleManagementTable.Operation</validator>
      </validation>
      <validation id="F23" description="Element values product-name and applicant must not be empty." severity="Error">
        <validator type="log" dependingOption="ca-51-5">ProductName.MustExist</validator>
        <validator type="log" dependingOption="ca-51-5">ApplicantMissing</validator>
      </validation>
      <validation id="F24" description="Cover letter should not have more than three pages." severity="Error">
        <validator type="log" dependingOption="ca-51-5">InvalidPageNumber</validator>
      </validation>
      <validation id="F25" description="Node extensions in module 1 backbone (ca-regional.xml) are not allowed, except in 1.2.6 Authorization for Sharing Information heading, 1.2.7 International Information heading, and 1.6.1 Comparative bioavailability Information heading. The validator checks all headings and subheadings in the Canadian regional backbone (ca-regional.xml). It generates an error when there is (are) node extension(s) found in any subheadings other than those mentioned above This rule does not apply to leaves with operation &quot;delete&quot;." severity="Error">
        <validator type="log" dependingOption="ca-51-5">CA.NotAllowExtensionM1</validator>
      </validation>
      <validation id="F26" description="Node extensions are expected in section 1.2.7 International Information heading.&#xA;Note: There is a mixture of node extensions and leaves allowed in the 1.2.7 International Information heading. A warning is generated when there is a (are) leaf (leaves) added under this heading. The warning serves the purpose to notify the user to manually verify the leaves added under this heading. Requirements are outlined below and will result in failure of the transaction if not followed: When provided, the International Status document and the Foreign review attestation must be added as leaves directly under 1.2.7 subheading. Any other foreign agency (such as FDA,. EMA) related documents must be provided using node extensions This rule does not apply to leaves with operation &quot;delete&quot;." severity="Warning">
        <validator type="log" dependingOption="ca-51-5">NodeExtensionsInSectionM127</validator>
      </validation>
      <validation id="F27" description="For node extensions, the title child must be present (value must be present)." severity="Error">
        <validator type="log" dependingOption="ca-51-5">NodeExtension.Title.Empty</validator>
        <validator type="log" dependingOption="ca-51-5">Leaf.Title.Empty</validator>
      </validation>
      <validation id="F28" description="The use of operation “append” is not allowed in module 1." severity="Error">
        <validator type="log" dependingOption="ca-51-5">CA.NotAppendLifecycleM1</validator>
      </validation>
    </validation>
    <validation id="6" description="G - ICH BACKBONE 3.2">
      <validation id="G01" description="Checks if referenced files have exactly one file extension." severity="Error">
        <validator type="log" dependingOption="ca-51-6">InconsistentExtensions</validator>
      </validation>
      <validation id="G02" description="The checksum-type attribute must have the value md5 or MD5." severity="Error">
        <validator type="log" dependingOption="ca-51-6">ChecksumType.Incorrect</validator>
      </validation>
      <validation id="G03" description="Checks if the attribute value is present." severity="Warning">
        <validator type="log" dependingOption="ca-51-6">ICHMetadataAttribute.EmptyValue</validator>
      </validation>
      <validation id="G04" description="Checks if the attribute value is present." severity="Warning">
        <validator type="log" dependingOption="ca-51-6">ICHMetadataAttribute.EmptyValue</validator>
      </validation>
      <validation id="G05" description="Checks if the attribute value is present." severity="Error">
        <validator type="log" dependingOption="ca-51-6">ICHMetadataAttribute.EmptyValue</validator>
      </validation>
      <validation id="G06" description="Checks if the attribute value is present. Applicable only to sections where this attribute is mandatory, otherwise reported as warning." severity="Error">
        <validator type="log" dependingOption="ca-51-6">ICHMetadataAttribute.EmptyValue</validator>
      </validation>
      <validation id="G07" description="Checks if the attribute value is present." severity="Warning">
        <validator type="log" dependingOption="ca-51-6">ICHMetadataAttribute.EmptyValue</validator>
      </validation>
      <validation id="G08" description="Checks if the attribute value is present. Applicable only to sections where this attribute is mandatory, otherwise reported as warning." severity="Error">
        <validator type="log" dependingOption="ca-51-6">ICHMetadataAttribute.EmptyValue</validator>
      </validation>
      <validation id="G09" description="Checks for elements not having any leaf child nodes. This only affects elements with a name that starts with 'm'." severity="Error">
        <validator type="log" dependingOption="ca-51-6">NoneLeafElement</validator>
      </validation>
      <validation id="G10" description="The index.xml file must be present." severity="Error">
        <validator type="log" dependingOption="ca-51-6">SchemaVersion</validator>
        <validator type="log" dependingOption="ca-51-6">Backbone.NotExist</validator>
        <validator type="log" dependingOption="ca-51-6">Regional.Backbone.Multiple</validator>
      </validation>
      <validation id="G11" description="The MD5 checksum file index-md5.txt must be present." severity="Error">
        <validator type="log" dependingOption="ca-51-6">SubmissionChecksum.Failed</validator>
        <validator type="log" dependingOption="ca-51-6">SubmissionChecksumFileName.Failed</validator>
      </validation>
      <validation id="G12" description="The m1 folder must be present." severity="Error">
        <validator type="log" dependingOption="ca-51-6">CA.M1Folder.NotExist</validator>
      </validation>
      <validation id="G13" description="The util folder must be present." severity="Error">
        <validator type="log" dependingOption="ca-51-6">Util.NotExisted</validator>
      </validation>
      <validation id="G14" description="For operations other than 'delete', all leafs must have a 'title' child. The title must be present." severity="Error">
        <validator type="log" dependingOption="ca-51-6">NodeExtension.Title.Empty</validator>
        <validator type="log" dependingOption="ca-51-6">Leaf.Title.Empty</validator>
      </validation>
      <validation id="G15" description="The element m1-administrative-information-and-prescribing information must be present." severity="Error">
        <validator type="log" dependingOption="ca-51-6">ICH.M1Root.NotExist</validator>
      </validation>
      <validation id="G16" description="The m1 folder must not have any other files in addition to the files explicitly allowed." severity="Error">
        <validator type="log" dependingOption="ca-51-6">SubmissionFolder.RedundantFiles</validator>
        <validator type="log" dependingOption="ca-51-6">M1Folder.RedundantFiles</validator>
        <validator type="log" dependingOption="ca-51-6">File.Extra</validator>
      </validation>
      <validation id="G17" description="The root folder (sequence number folder) must not have any other files in addition to the files explicitly allowed." severity="Error">
        <validator type="log" dependingOption="ca-51-6">SubmissionFolder.RedundantFiles</validator>
        <validator type="log" dependingOption="ca-51-6">M1Folder.RedundantFiles</validator>
        <validator type="log" dependingOption="ca-51-6">File.Extra</validator>
      </validation>
      <validation id="G18" description="For node extensions, the title child must be present (value must be present)." severity="Error">
        <validator type="log" dependingOption="ca-51-6">NodeExtension.Title.Empty</validator>
        <validator type="log" dependingOption="ca-51-6">Leaf.Title.Empty</validator>
      </validation>
      <validation id="G19" description="Regional backbone(s) referenced (ca-regional.xml) should have 'new' operation attribute." severity="Warning">
        <validator type="log" dependingOption="ca-51-6">RegionalBackboneReferenced.WrongOperationAttribute</validator>
      </validation>
      <validation id="G20" description="Checks for documents in the ICH backbone, which are used as modified-file more than once." severity="Error">
        <validator type="log" dependingOption="ca-51-6">MultipleOperationOnSingleLeaf</validator>
      </validation>
      <validation id="G21" description="Checks for file reuse scenarios (Same values for xlink:href used multiple times in the regional backbone for this sequence)." severity="Information">
        <validator type="log" dependingOption="ca-51-6">Href.Reused</validator>
      </validation>
      <validation id="G22" description="Valid file extensions include: Documents:.pdf,.doc,.docx,.xls,.xlsx,.wpd,.ppt,.pptx;Images:.png,.gif,.svg,.jpg,.jpeg,.tif,.tiff,.bmp;Audio/Video:.wav,.mp3,.mp4,.wmv,.mov,.mpg,.mpeg;Coding Language:.xml,.xsl,.xsd,.dtd;Data, Modeling and Simulation:.dat,.inf,.txt,.sas,.xpt .wksz,.wksx,.wks (SimCyp workspace files, Pharmaceutical Drugs only) .sdax,.edpdp,.wsp,.epr,.pnf,.psf (Consistency Lot Release Testing Activities, Biologic Drugs only)" severity="Error">
        <validator type="log" dependingOption="ca-51-6">FileType.Invalid</validator>
      </validation>
      <validation id="G23" description="When replacing or appending content, the new content should be different from the previous content." severity="Error">
        <validator type="log" dependingOption="ca-51-6">File.ICHCompareContent</validator>
      </validation>
      <validation id="G24" description="The number of leaves directly under a single node must not exceed 1000. This rule applies only to module 5 when using node extensions and only to leaves with operation attribute &quot;new&quot;." severity="Error">
        <validator type="log" dependingOption="ca-51-6">LeavesSingleNodeLimited</validator>
      </validation>
      <validation id="G25" description="Detect invalid life cycle pattern: Append operations causing branches." severity="Error">
        <validator type="log" dependingOption="ca-51-6">InvalidLifeCycleOperation.Replace</validator>
        <validator type="log" dependingOption="ca-51-6">InvalidLifeCycleOperation.Append</validator>
        <validator type="log" dependingOption="ca-51-6">InvalidLifeCycleOperation.Delete</validator>
      </validation>
      <validation id="G26" description="Detect invalid life cycle pattern: Append operations not appending to most recent STF leaf." severity="Error">
        <validator type="log" dependingOption="ca-51-6">Stf.AppendOperation</validator>
      </validation>
      <validation id="G27" description="Detect invalid life cycle pattern: Delete operations causing branches." severity="Error">
        <validator type="log" dependingOption="ca-51-6">InvalidLifeCycleOperation.Replace</validator>
        <validator type="log" dependingOption="ca-51-6">InvalidLifeCycleOperation.Append</validator>
        <validator type="log" dependingOption="ca-51-6">InvalidLifeCycleOperation.Delete</validator>
      </validation>
      <validation id="G28" description="Detect invalid life cycle pattern: Replace operations causing branches." severity="Error">
        <validator type="log" dependingOption="ca-51-6">InvalidLifeCycleOperation.Replace</validator>
        <validator type="log" dependingOption="ca-51-6">InvalidLifeCycleOperation.Append</validator>
        <validator type="log" dependingOption="ca-51-6">InvalidLifeCycleOperation.Delete</validator>
      </validation>
      <validation id="G29" description="Detect invalid life cycle pattern: Operation on deleted leaf content." severity="Error">
        <validator type="log" dependingOption="ca-51-6">InvalidLifeCycleOperation.MultipleDelete</validator>
      </validation>
      <validation id="G30" description="Detect invalid life cycle pattern: Append on Append." severity="Warning">
        <validator type="log" dependingOption="ca-51-6">InvalidLifeCyclePatternAppendOnAppend</validator>
      </validation>
      <validation id="G31" description="Do not provide strength values in the dosage form attribute in sections 2.3.P, 3.2.P, 3.2.A.1, or 3.2.A.2. Any numeric value found in these attribute values will be reported as an error. If the strength value was already present in a previous sequence, the rule will not report an error for the current sequence." severity="Error">
        <validator type="log" dependingOption="ca-51-6">DosageStrengthExistence</validator>
      </validation>
      <validation id="G32" description="This applies to leaf elements in the ICH sections modules 2-5. When revisions are sent to a regulatory authority, the new leaf element should be submitted in the same location in the backbone as the leaf element being appended, replaced or deleted." severity="Error">
        <validator type="log" dependingOption="ca-51-6">ModifiedFile.NotInSameSection</validator>
      </validation>
      <validation id="G33" description="This check will examine the SAS XPT dataset files (XPORT). Files that are corrupt or compressed will be reported as Error. For details about the technical specifications, please refer to the FDA study data technical conformance guide." severity="Error">
        <validator type="log" dependingOption="ca-51-6">CorruptedOrCompressedSasXptFile</validator>
      </validation>
      <validation id="G34" description="Leaf elements in 3.2.R Regional Information heading must be provided using node extensions. PDF files are not allowed as leaf elements directly under 3.2.R Regional Information heading. Acceptable titles of the node extensions are: 3.2.R.1 Production Documentation;3.2.R.2 Medical Devices;3.2.R.3 Lot Release Documentation;3.2.R.4 Yearly Biologic Product Report;3.2.R.5 Assessment of Similarity;3.2.R.6 On Site Evaluation;3.2.R.7 Other Regional Information;3.2.R.8 Product Lifecycle Management Information;Warning will be reported if the naming of the title is not followed. Notes:&#xA;The requirements above apply only to leaves provided using operation attribute &quot;New&quot;. They don't apply to leaves provided using operation attribute &quot;Replace&quot;. The exact naming convention of the titles of node extensions must be used when the node extension(s) is (are) created for the first time under this heading. If new or replaced leaves are provided when there are already existing node extensions in the 3.2.R Regional information heading, the leaves must be provided under the existing node extensions, even if they don't follow the exact naming convention of the node extension title. Warning generated during the validation can be ignored." severity="Error">
        <validator type="log" dependingOption="ca-51-6">NamingConventionNodeExtensions</validator>
        <validator type="log" dependingOption="ca-51-6">LeafElementsIn32R</validator>
      </validation>
    </validation>
    <validation id="7" description="H - STF 2.2">
      <validation id="H01" description="Verifies that the href target exists and has the correct value." severity="Error">
        <validator type="log" dependingOption="ca-51-7">Stf.LeafId.NotExist</validator>
      </validation>
      <validation id="H02" description="Verifies that the href target exists and matches the title value." severity="Warning">
        <validator type="log" dependingOption="ca-51-7">Stf.DocContent.Title.NotMatch</validator>
      </validation>
      <validation id="H03" description="Reports any used content-block element." severity="Warning">
        <validator type="log" dependingOption="ca-51-7">Stf.ContentBlock.NotAccepted</validator>
      </validation>
      <validation id="H04" description="Verifies that href values do not contain backslashes." severity="Error">
        <validator type="log" dependingOption="ca-51-7">StfHrefHasBackslashes</validator>
      </validation>
      <validation id="H05" description="The value of the study-identifier/category element must not be empty." severity="Warning">
        <validator type="log" dependingOption="ca-51-7">Stf.Categories.Empty</validator>
      </validation>
      <validation id="H06" description="The value of the study-identifier/study-id element must not be empty." severity="Warning">
        <validator type="log" dependingOption="ca-51-7">Stf.StudyId.Empty</validator>
        <validator type="log" dependingOption="ca-51-7">Stf.NotExist</validator>
      </validation>
      <validation id="H07" description="The value of the study-identifier/title element must not be empty." severity="Warning">
        <validator type="log" dependingOption="ca-51-7">Stf.Title.Empty</validator>
      </validation>
      <validation id="H08" description="Checks file tag values and category values against definitions in valid-values.xml file. Accepting values as defined in valid-values.xml v5." severity="Error">
        <validator type="log" dependingOption="ca-51-7">Stf.FileTag.NotSupported</validator>
        <validator type="log" dependingOption="ca-51-7">Stf.Category.NotSupported</validator>
      </validation>
      <validation id="H09" description="STF leaf element must reference other STF leaf upon append.&#xA;Such leaf elements must not reference PDF files as modified files." severity="Error">
        <validator type="log" dependingOption="ca-51-7">Stf.Append.ReferenceOtherStf</validator>
      </validation>
      <validation id="H10" description="Category information must be provided for certain STFs." severity="Warning">
        <validator type="log" dependingOption="ca-51-7">Stf.Category.Missing</validator>
      </validation>
      <validation id="H12" description="Leaf references in STFs must always target content files, not STFs." severity="Warning">
        <validator type="log" dependingOption="ca-51-7">Stf.ReferenceStf</validator>
      </validation>
      <validation id="H13" description="STF files must reference at least one leaf." severity="Warning">
        <validator type="log" dependingOption="ca-51-7">Stf.NotHasReferencedLeaf</validator>
      </validation>
      <validation id="H14" description="The STF study IDs must not change in the application life cycle." severity="Warning">
        <validator type="log" dependingOption="ca-51-7">Stf.StudyId.NotMatch</validator>
      </validation>
      <validation id="H15" description="STFs should only be associated with certain headings under Modules 4 or 5." severity="Warning">
        <validator type="log" dependingOption="ca-51-7">Stf.WrongSection</validator>
      </validation>
      <validation id="H16" description="There should be one and only one file tag for each doc-content." severity="Warning">
        <validator type="log" dependingOption="ca-51-7">Stf.FileTag.NotExist1</validator>
        <validator type="log" dependingOption="ca-51-7">Stf.FileTag.MultiTag1</validator>
        <validator type="log" dependingOption="ca-51-7">Stf.FileTag.MultiTag</validator>
      </validation>
      <validation id="H19" description="If Study Tagging Files are used in the current sequence being validated, the node 5.3.7 must not be used. The Case Report Forms must be referenced from the Study Tagging Files. The previous sequences in the same dossier will not be checked." severity="Error">
        <validator type="log" dependingOption="ca-51-7">CaseReportFormsReference</validator>
      </validation>
      <validation id="H20" description="Leaf elements in module 4 (except those in subsection 4.3), with an operation attribute &quot;new&quot;, can use either node extensions, STFs or may be placed directly under the TOC sections. Leaf elements in subsections 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, and 5.3.7, with an operation attribute &quot;new&quot;, can use only node extensions or STFs. Although both node extensions and STFs are acceptable for study reports, only one or the other approach should be used consistently throughout the lifecycle of a leaf. Also, in a specific sequence all leaf elements should use the same approach. Note: Previous sequences in the same dossier will not be checked, and neither will leaf elements with operation attributes other than &quot;new&quot;." severity="Error">
        <validator type="log" dependingOption="ca-51-7">UsingNodeExtensionAndStfIn53</validator>
        <validator type="log" dependingOption="ca-51-7">StudyReportSameApproach</validator>
        <validator type="log" dependingOption="ca-51-7">UsingNodeExtensionAndStfIn43</validator>
        <validator type="log" dependingOption="ca-51-7">LifecycleApproachConsistently</validator>
      </validation>
    </validation>
    <validation id="8" description="I - Regulatory Enrolment Process (REP only)">
      <validation id="I01" description="An XML file will be reported as corrupt if the file cannot be opened because the file is damaged." severity="Error">
        <validator type="log" dependingOption="ca-51-8">CA.CorruptOrUnreadableXml</validator>
      </validation>
      <validation id="I02" description="Checks the 1.2.1 Application Forms node. Generates error if the RT file is missing from the current eCTD sequence and was provided in the previous eCTD sequence.&#xA;Note: This rule is not based on the presence of the RT file in the current sequence. This rule is based on the existence of the RT XML file or MF XML in the previous eCTD sequence. Error must not be generated if there is no RT xml or MF XML file present in the previous eCTD sequence." severity="Error">
        <validator type="log" dependingOption="ca-51-8">RTFileMissing</validator>
      </validation>
      <validation id="I03" description="Verifies the placement of the RT, PI or MF xml files. Generates error if they are placed in a node other than 1.2.1 Application Forms." severity="Error">
        <validator type="log" dependingOption="ca-51-8">RtPiFileInWrongPlace</validator>
      </validation>
      <validation id="I04" description="Checks the 1.2.1 Application Forms node. Generates error if, in addition to the RT xml file, there is a 3011 form named hc-sc-3011-en.pdf or hc-sc-3011-fr.pdf." severity="Error">
        <validator type="log" dependingOption="ca-51-8">HCSCFileExisted</validator>
      </validation>
      <validation id="I05" description="Checks the 1.2.1 Application Forms node. Generates error if in addition to the RT xml and/or PI xml file there are other xml files Error will also be reported if more than one RT XML file is found in this node." severity="Error">
        <validator type="log" dependingOption="ca-51-8">DuplicateRtFile</validator>
        <validator type="log" dependingOption="ca-51-8">OtherXmlFileExisted</validator>
      </validation>
      <validation id="I06" description="Compares the value in the Dossier ID field in the RT or MF xml file with the top level folder." severity="Error">
        <validator type="log" dependingOption="ca-51-8">DossierIdNotMatch</validator>
      </validation>
      <validation id="I07" description="The operation attribute value in the leaf element must be “new” when provided for the first time, and “replace” when provided in subsequent transaction." severity="Error">
        <validator type="log" dependingOption="ca-51-8">CA.ValidOperationLifecycleForRT</validator>
      </validation>
      <validation id="I08" description="Checks the Dossier ID field in the RT or MF XML file. It must be lower case letter “e” followed by 6 digits." severity="Error">
        <validator type="log" dependingOption="ca-51-8">NamingConventionDossierId</validator>
      </validation>
      <validation id="I09" description="Element values for “product_name” and “company_id” must not be empty." severity="Error">
        <validator type="log" dependingOption="ca-51-8">ProductAndCompanyNotEmpty</validator>
      </validation>
      <validation id="I11" description="Checks the software_version element value of the Regulatory Transaction (RT) and Master File (MF) XML files. For the latest versions of the RT and MF XML files accepted by Health Canada refer to:  REP Summary Table - for Human Use Drugs (pharmaceutical, biologic and radiopharmaceutical), disinfectants, veterinary drugs and medical devices;Filling submissions electronically - for master files" severity="Error">
        <validator type="log" dependingOption="ca-51-8">SchemaVersionNotEmpty</validator>
      </validation>
    </validation>
    <validation id="9" description="XML PM - 1 General">
      <validation id="1.01" description="XML files must be well formed and valid against the schema." severity="Error">
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.XMLSchema</validator>
      </validation>
      <validation id="1.02" description="Referenced image files must be JPEG with the.jpeg extension." severity="Error">
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.ReferencedImageType</validator>
      </validation>
      <validation id="1.03" description="All referenced image files must exist in the same folder as the XML file." severity="Error">
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.ReferencedImageUri</validator>
      </validation>
      <validation id="1.04" description="XML files must be named with the (Globally Unique Identifiers) GUID from the &lt;document&gt; &lt;ID&gt; root attribute." severity="Error">
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.XMLFileName</validator>
      </validation>
      <validation id="1.05" description="Values for &lt;setID&gt; root attribute and &lt;id&gt; root attribute must not be empty, be unique and be a GUID.
          GUIDs must follow the canonical structure, content and formatting rules: displayed in five groups separated by hyphens, in the form 8-4-4-4-12 for a total of 36 characters (32 alphanumeric characters and four hyphens) and permitted characters only include a-f,0-9,-
          Note: Rule does not apply to &lt;representedOrganization&gt; root attribute and &lt;assignedOrganization&gt; root attribute." severity="Error">
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.RootAttribute</validator>
      </validation>
      <validation id="1.06" description="Date values associated with &lt;effectiveTime&gt; must be provided in the format YYYYMMDD." severity="Error">
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.EffectiveTime</validator>
      </validation>
      <validation id="1.07" description="Coded values and display names must be equal to the associated CV." severity="Error">
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.CodeAndDisplayName</validator>
      </validation>
      <validation id="1.08" description="Coded values must include a valid codeSystem attribute or root attribute and must be present only in allowable context as outlined in Appendix 1 - Valid codeSystem attributes or root attribute in allowable contexts." severity="Error">
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.ValidCodeSystemRootAttribute</validator>
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.CodeSystemRootAttributeNotPermitted</validator>
      </validation>
      <validation id="1.09" description="Coded value terms used should have Status = &quot;Active&quot; from the CV system. Other status values will lead to Warnings or Errors. The overall rule severity will be the highest severity of the non-Active values based on the &quot;Controlled vocabulary&quot; table." severity="Error">
        <validator type="log" dependingOption="ca-51-9">StatusCodeSystem4XMLPM</validator>
      </validation>
      <validation id="1.10" description="displayName attributes must be equal to the language-specific CV display name. This does not apply to:&#xA;&lt;representedOrganization&gt; &lt;Id&gt; root attribute 2.16.840.1.113883.2.20.6.31.;&lt;assignedOrganization&gt; &lt;Id&gt; root attribute 2.16.840.1.113883.2.20.6.31." severity="Error">
        <validator type="log" dependingOption="ca-51-9">DisplayName4XMLPM</validator>
      </validation>
      <validation id="1.11" description="&lt;id&gt; extension attributes must not contain spaces." severity="Error">
        <validator type="log" dependingOption="ca-51-9">IdExtensionContainSpace4XMLPM</validator>
      </validation>
      <validation id="1.12" description="&lt;text&gt;, &lt;title&gt;, &lt;caption&gt; and &lt;content&gt; must not be empty between opening and closing tags." severity="Error">
        <validator type="log" dependingOption="ca-51-9">TagEmpty4XMLPM</validator>
      </validation>
      <validation id="1.13" description="&lt;characteristics&gt; must not have a classCode attribute." severity="Error">
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.Characteristics</validator>
      </validation>
      <validation id="1.14" description="Major section headings listed below must not be immediately followed by &lt;text&gt; or &lt;paragraph&gt;: Code = &quot;0TP&quot; (TITLE PAGE);Code = &quot;pi00&quot; (PART I: HEALTH PROFESSIONAL INFORMATION);Code = &quot;pii00&quot; (PART II: SCIENTIFIC INFORMATION);Code = &quot;pim00&quot; (PATIENT MEDICATION INFORMATION)" severity="Error">
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.ContentMajor</validator>
      </validation>
      <validation id="1.15" description="The following elements and attributes must not be used: &lt;performance&gt;;&lt;actDefinition&gt;;&lt;product&gt;;&lt;manufacturedMaterialKind&gt;;&lt;confidentialityCode&gt;" severity="Error">
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.ElementAtribute</validator>
      </validation>
      <validation id="1.16" description="No comments (i.e. &quot;&lt;!-- -- &gt;&quot;) are allowed." severity="Error">
        <validator type="log" dependingOption="ca-51-9">Invalid.PM.Comments</validator>
      </validation>
    </validation>
    <validation id="10" description="XML PM - 2 XML Prolog">
      <validation id="2.01" description="&lt;?xml&gt; version attribute must be equal to &quot;1.0&quot;. The encoding attribute must equal &quot;UTF-8&quot;." severity="Error">
        <validator type="log" dependingOption="ca-51-10">XmlPmVersionMessage</validator>
        <validator type="log" dependingOption="ca-51-10">XmlPmEncodeMessage</validator>
      </validation>
      <validation id="2.02" description="&lt;?xml-stylesheet&gt; href attribute must be equal to &quot;https://health-products.canada.ca/product-monograph/style-sheet/v_#_#/spl_canada.xsl&quot;." severity="Error">
        <validator type="log" dependingOption="ca-51-10">XmlPmFormatHrefMessage</validator>
      </validation>
      <validation id="2.03" description="Only &lt;?xml&gt; and &lt;?xml-stylesheet&gt; XML declarations are allowed." severity="Error">
        <validator type="log" dependingOption="ca-51-10">XmlPmDeclarationMessage</validator>
      </validation>
      <validation id="2.04" description="Values for style sheet version &quot;v_#_#&quot; must be taken from CV codeSystem 2.16.840.1.113883.2.20.6.65 and must be equal to a CV Code. The overall rule severity will be the highest severity of the non-Active values based on the &quot;Style sheet version&quot; table." severity="Error">
        <validator type="log" dependingOption="ca-51-10">XmlPmStyleSheetVersionMessage</validator>
      </validation>
    </validation>
    <validation id="11" description="XML PM - 3 Document">
      <validation id="3.01" description=" &lt;document&gt; xmlns attribute must be equal to &quot;urn:hl7-org:v3&quot;.
        &lt;document&gt; xsi:schemaLocation attribute must be equal to &quot;https://health-products.canada.ca/product-monograph/schema/SPL.xsd&quot;." severity="Error">
        <validator type="log" dependingOption="ca-51-11">Invalid.PM.SchemaLocationNotEqual</validator>
      </validation>
      <validation id="3.02" description="&lt;document&gt; &lt;id&gt; root attribute must not be empty, be unique and be a GUID." severity="Error">
        <validator type="log" dependingOption="ca-51-11">Invalid.PM.DocumentIdentifierIsNotGUID</validator>
      </validation>
      <validation id="3.03" description="Values for &lt;document&gt; &lt;code&gt; must be taken from CV codeSystem 2.16.840.1.113883.2.20.6.10. Specifically:&#xA;The code attribute value must be equal to a CV Code. The displayName attribute must be equal to the language-specific CV display name for that Code." severity="Error">
        <validator type="log" dependingOption="ca-51-11">Invalid.PM.DocumentTypeIncorrect</validator>
      </validation>
      <validation id="3.04" description="Values for &lt;languageCode&gt; must be taken from CV codeSystem 2.16.840.1.113883.2.20.6.29. Specifically: The code attribute value must be equal to a CV Code. The displayName attribute must be equal to the language-specific CV display name for that Code." severity="Error">
        <validator type="log" dependingOption="ca-51-11">Invalid.PM.LanguageIncorrect</validator>
      </validation>
      <validation id="3.05" description="&lt;setId&gt; root attribute must not be empty, be unique and be a GUID." severity="Error">
        <validator type="log" dependingOption="ca-51-11">Invalid.PM.DocumentIdIncorrect</validator>
      </validation>
      <validation id="3.06" description="&lt;versionNumber&gt; value attribute must be an integer greater than zero." severity="Error">
        <validator type="log" dependingOption="ca-51-11">Invalid.PM.DocumentVersionNumberIncorrect</validator>
      </validation>
    </validation>
    <validation id="12" 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="ca-51-12">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="ca-51-12">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="ca-51-12">Index.Checksum.InvalidFormat</validator>
      </validation>
      <validation id="Recommended" description="Ensure that 'Fast Web Access' is enabled for all PDF files in the submission" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">PdfFastWebAccess</validator>
      </validation>
      <validation id="Recommended" description="Ensure that all lowest level heading elements included in the submission (index and regional xml file - section, node extension and/or nested node extensions) must contain one leaf" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">FolderEmpty</validator>
      </validation>
      <validation id="Recommended" description="Ensure that value for ID attribute must start with a letter or underscore character" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">LeafId.Invalid</validator>
      </validation>
      <validation id="Recommended" description="Ensure there is no reference leaf(s) point to a file (outside of the eCTD lifecycle) across application (xlink:href points to a different application)" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">References.AcrossApplication</validator>
      </validation>
      <validation id="Recommended" description="Ensure that the Sequence Number contains four digits (i.e. numbers between 0000 to 9999) in the regional xml file and in the sequence folder" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">SequenceNumberCharacters</validator>
      </validation>
      <validation id="Recommended" description="Ensure that the syntax of the modified-file attribute is in accordance with the ICH 3.2 DTD version" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">ModifiedFile.IncorrectSyntax</validator>
      </validation>
      <validation id="Recommended" description="Ensure that the names of all files and folders in the submission corresponds to the ICH and/or regional agency defined folder structure and file names (i.e. extra subfolders should be reported, 'rp' or 'ap' suffix in file names of the ASMF submission shall be ignored by the validation)" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">M1.NamingConvention.NotMatch</validator>
        <validator type="log" dependingOption="ca-51-12">NamingConvention.Inconsistent</validator>
      </validation>
      <validation id="Recommended" description="Ensure that the reference to the stylesheet in the backbone xml files are directed to the stylesheet provided in the util folder" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">InvalidStyleSheetLocation</validator>
      </validation>
      <validation id="Recommended" description="Ensure that the reference to the DTD or schema in the backbone xml files are directed to the DTD or schema provided in the util folder" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">InvalidSchemaOrDtdLocation</validator>
      </validation>
      <validation id="Recommended" description="Ensure that index MD5 txt file is named correctly (i.e. index-md5.txt)" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">SubmissionChecksumFileName.Failed</validator>
      </validation>
      <validation id="Recommended" description="Ensure that a valid ICH, regional and STF stylesheet exists in the util folder (i.e. checksum of the ICH and regional stylesheets in util folder must match the published checksum of the stylesheet provided by the agency) of the compiled and/or imported submission" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">StyleSheetChecksumFailed</validator>
      </validation>
      <validation id="Recommended" description="Ensure that ICH and regional xml backbone files are named correctly" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">EU_CH_GC_AUBackbone.NotExist</validator>
      </validation>
      <validation id="Recommended" description="Ensure that all required ICH and regional DTD (including .mod files) and/or Schema files referenced in the submission must exists in correct location (i.e. &lt;app-id&gt;\&lt;seq-num&gt;\util\dtd) and these files are named correctly" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">UtilFilesInvalidPath</validator>
      </validation>
      <validation id="Recommended" description="Ensure that ICH and regional stylesheet files exist in correct location (i.e. &lt;app-id&gt;\&lt;seq-num&gt;\util\style) and are named correctly" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">StyleSheetExist</validator>
      </validation>
      <validation id="Recommended" description="Ensure that all hyperlinks and bookmarks between two PDFs must be configured as specified in ISO 32000-1:2008 (link path must not contain back slash, only forward slash is allowed, links must not be made with Java script code)" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">PdfBackslash</validator>
        <validator type="log" dependingOption="ca-51-12">PdfBackslashBookmark</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="ca-51-12">RefOutsideSeqOrApp</validator>
        <validator type="log" dependingOption="ca-51-12">RefOutsideSeqOrAppBookmark</validator>
      </validation>
      <validation id="Recommended" description="Ensure that the ICH DTD version used in the current sequence (sequence being tested) is equal to or lower than the DTD version used in the numerically succeeding sequence of the application" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">IchDtdVersionSucceeding</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="ca-51-12">RegionalDtdVersionSucceeding</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="ca-51-12">PdfAnnotations</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="ca-51-12">RefDocCorrupted</validator>
        <validator type="log" dependingOption="ca-51-12">RefDocCorruptedBookmark</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="ca-51-12">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="ca-51-12">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="ca-51-12">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="ca-51-12">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="ca-51-12">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="ca-51-12">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="ca-51-12">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="ca-51-12">InvalidStfFileName</validator>
      </validation>
      <validation id="Recommended" description="Ensure that files in study sections are referenced by an STF" severity="Warning">
        <validator type="log" dependingOption="ca-51-12">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="ca-51-12">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="ca-51-12">Leaf.Title.LeadsOrEndsWithSpace</validator>
        <validator type="log" dependingOption="ca-51-12">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="ca-51-12">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="ca-51-12">IchDtdVersion</validator>
        <validator type="log" dependingOption="ca-51-12">RegionalDtdVersion</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="ca-51-12">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="ca-51-12">File.Extra.InUtil</validator>
      </validation>
      <validation id="Recommended" description="Report following information about the STFs in the submission (number and total size of non E3 documents). [Non E3 study files] Total size (KB): -- ;Number of 16.3 files: -- (value is determined by keeping count of ICH file tags in STF); Number of US files: -- (value is determined by keeping count of US file tags in STF);Number of JP files: -- (value is determined by keeping count of JP file tags in STF)" severity="Information">
        <validator type="log" dependingOption="ca-51-12">Stf.E3Info</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="ca-51-12">Xml.StyleSheet</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="ca-51-12">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. Note: This is applicable for: Module 4 : section 4.2.3.1, 4.2.3.2, 4.2.3.4; 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="ca-51-12">Stf.FileName.Specific</validator>
      </validation>
    </validation>
  </validations>
</validationreport>