Copyright 2011 LORENZ Life Sciences Group (3.1 SP1 HF2)
LORENZ eValidator™ - Application Validation Report
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Application Namea-1
Application Path d:\20110901 test case human checker\site\a-1\0000\
Sequence Number0000
Available preceding Sequencesn/a
Used ProfileEurope - EU, all countries [eCTD v3.1, NeeS v2.1] /NeeS
Profile StatusProtected. Signature ok.
User prv  [Basic license with restricted feature set.]
Validation Start (UTC)31/08/2011 09:08:34
Runtime (hh:mm:ss)00:00:03
Total Files177
Total Folders183
Total Size (MB)1.41
Total PDF Documents177
Total Pages (PDF)181
Errors found
0
Warnings found
187


General


Application Folder Requirements
OK
Validation Criteria Reference: 2.BP1
This rule's implementation verifies that the application folder exists (i.e. that sequence is not a direct child folder of the drive root)

Empty Folders
OK
Validation Criteria Reference: 2.7
This rule's implementation checks for empty folders in the application hierarchy.

File Size
OK
Validation Criteria Reference: 2.BP2
This rule's implementation checks for files that exceed the configured maximum size.

Sequence Folder Requirements
OK
Validation Criteria Reference: 2.3
Sequence number must be numeric (4 digits).






PDF Analysis


Bookmarks - Absolute (Rooted), broken
OK
Validation Criteria Reference: 3.BP8
Finds all broken non-relative bookmarks in PDF documents and prints the total count.

  • No broken rooted bookmarks found.

    Bookmarks - Absolute (Rooted)
    OK
    		Validation Criteria Reference: 3.BP8
    Finds all non-relative bookmarks in PDF documents and prints the total count.

    • No rooted bookmarks found.

      Bookmarks - Destination Zoom
      OK
      		Validation Criteria Reference: 3.BP4
      Finds all bookmarks in PDF documents, which do not have Inherit Zoom set.

      • No bookmarks with invalid destination zoom found.

        Bookmarks - Intra Sequence, broken
        OK
        		Validation Criteria Reference: 3.BP3
        Finds all broken intra-sequence bookmarks in PDF documents and prints the total count.

        • No broken intra-sequence bookmarks found.

          Hyperlinks - Absolute (Rooted), broken
          OK
          		Validation Criteria Reference: 3.BP7
          Finds all broken non-relative hyperlinks in PDF documents and prints the total count.

          • No broken rooted hyperlinks found.

            Hyperlinks - Absolute (Rooted)
            OK
            		Validation Criteria Reference: 3.BP7
            Finds all non-relative hyperlinks in PDF documents and prints the total count.

            • No rooted hyperlinks found.

              Hyperlinks - Destination Zoom
              Warning
              		Validation Criteria Reference: 3.BP4
              Finds all hyperlinks in PDF documents, which do not have Inherit Zoom set.

              Links found:
              • 181

                Hyperlinks - Intra Sequence, broken
                OK
                		Validation Criteria Reference: 3.BP2
                Finds all broken intra-sequence hyperlinks in PDF documents and prints the total count.

                • No broken intra-sequence hyperlinks found.

                  NeeS TOC documents: Broken links
                  OK
                  		Validation Criteria Reference: 1.5, 1.6
                  Checks all links (both hyperlinks and bookmarks) in NeeS TOC documents. Any broken link therein will be reported by this check.

                  • No broken links found in these documents.

                    NeeS TOC documents: Rooted (absolute) links
                    OK
                    		Validation Criteria Reference: 3.4
                    Checks all links (both hyperlinks and bookmarks) in NeeS TOC documents. Any rooted (absolute) link therein will be reported by this check.

                    • No rooted (absolute) links found in these documents.

                      PDF Documents, corrupted
                      OK
                      		Validation Criteria Reference: 3.2
                      Checks for PDF documents which cannot be opened. Also checks for PDF document with a page count of 0.

                      • No corrupted documents found.

                        PDF Fast Web View Optimization
                        Warning
                        		Validation Criteria Reference: 3.BP5
                        Checks for any PDF documents that are not optimized for fast web view (not linearized).

                        PDF documents without fast web view optimization (not linearized)
                        • 6

                          PDF initial view
                          OK
                          		Validation Criteria Reference: 3.BP6
                          Checks for PDF documents which do not show the bookmarks pane (applies to documents with bookmarks). Checks also for document magnification and page layout being default.

                          • No documents with incorrect initial view found.

                            PDF Protection: Accessibility
                            OK
                            		Validation Criteria Reference: 3.3
                            Checks for PDF documents, which do not allow copying content for screen reader access (for users with disabilities). Also PDF documents that are encrypted will be reported here (regardless of any actual protection set).

                            • No such documents found.

                              PDF Protection: Commenting
                              OK
                              		Validation Criteria Reference: 3.3
                              Checks for PDF documents, which do not allow adding comments.

                              • No such documents found.

                                PDF Protection: Content changes
                                OK
                                		Validation Criteria Reference: 3.3
                                Checks for PDF documents, which do not allow changes to the content.

                                • No such documents found.

                                  PDF Protection: Copy or extract content
                                  OK
                                  		Validation Criteria Reference: 3.3
                                  Checks for PDF documents, which do not allow copying or extracting content.

                                  • No such documents found.

                                    PDF Protection: Printing
                                    OK
                                    		Validation Criteria Reference: 3.3
                                    Checks for PDF documents, which do not allow printing.

                                    • No such documents found.

                                      PDF Protection: Signing, form field filling
                                      OK
                                      		Validation Criteria Reference: 3.3
                                      Checks for PDF documents, which do not allow signing or filling form fields.

                                      • No such documents found.

                                        PDF Protection: User password
                                        OK
                                        		Validation Criteria Reference: 3.2
                                        Checks for PDF documents, which require a password upon opening.

                                        • No such documents found

                                          PDF version checking (not recommended versions)
                                          OK
                                          		Validation Criteria Reference: 3.BP1
                                          Checks for PDF document versions newer than 1.4. These versions are not recommended.

                                          • All PDF document versions ok.

                                            PDF Version checking
                                            OK
                                            		Validation Criteria Reference: 3.1
                                            Checks for PDF document versions lower (older) than the ones listed in the corresponding category setting. PDF version 1.4 is the standard. PDF 1.3 or older are not accepted.

                                            • All PDF document versions ok.






                                              Referenced Files


                                              Naming Syntax
                                              OK
                                              		Validation Criteria Reference: 2.4, 2.5, 2.6, 2.8, 2.9
                                              Checks the syntax all referenced file names (path length, illegal characters, etc.).

                                              Unreferenced Files
                                              OK
                                              		Validation Criteria Reference: 1.5, 1.6, 1.7
                                              Searches for files not referenced in an index file (ICH, Regional or STF). For non eCTD applications, this will list all files that are not reachable through a bookmark or hyperlink in any of the TOC files.






                                              EU Regional - 1.4


                                              Adherence to Naming Conventions
                                              OK
                                              		Validation Criteria Reference: 2.10, 2.11
                                              Checks if the naming conventions for eu 1.4 are followed.

                                              ctd-toc.pdf exists
                                              OK
                                              		Validation Criteria Reference: 1.1, 1.2, 1.3

                                              Invalid file extension used (EU crit. 2.1)
                                              OK
                                              		Validation Criteria Reference: 2.1, 2.2
                                              Only the following file types are allowed: pdf, jpeg, png, svg, gif, sas, xml

                                              Module TOCs
                                              OK
                                              		Validation Criteria Reference: 1.4
                                              If Module TOC files are present, each and every module folder (/m1, /m2, etc.) contains the correctly named Module TOC file






                                              ICH Backbone - 3.2


                                              Adherence to Naming Conventions (folders)
                                              OK
                                              		Validation Criteria Reference: 2.10
                                              Checks if the folder naming conventions for this backbone/regional are followed.

                                              Adherence to Naming Conventions (m4, m5)
                                              OK
                                              		Validation Criteria Reference: 2.BP3
                                              Checks if the file naming conventions for this backbone/regional are followed.

                                              Adherence to Naming Conventions (root, m2, m3)
                                              OK
                                              		Validation Criteria Reference: 2.11
                                              Checks if the file naming conventions for this backbone/regional are followed.

                                              M2 23-qos Granularity
                                              OK
                                              		Validation Criteria Reference: 2.11
                                              In folder 23-qos either a single file qos[-var].pdf can be provided or a selection of introduction-var.pdf, drug-substance-var.pdf, drug-product-var.pdf, appendices-var.pdf, regional-information-var.pdf .