Configuring PDF and ZIP Package Export

You can configure how Market Registration exports packages. The default values conform to the FDA format. You can define properties for exporting to a PDF file or to a ZIP file.

  1. Create or open the text file for customized properties. For more information, see Editing Properties Using MQL.
  2. To define the types of files that will be exported, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object:

      Regulatory.PackageExport.StatisticalFileTypes=sas,xport,xml,sgml,xls,xlsx,mol
      Regulatory.PackageExport.MediaVideoFileTypes=avi,wmv
      Regulatory.PackageExport.MediaImageFileTypes=gif,tif,jpg,jpeg

    2. Enter or edit the comma-separated list of file formats to define the statistical, video, and image file types that will be exported to a package.
  3. To define how the PDF files will be exported, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object:

      Regulatory.PackageExport.FolderPrefix=VOL
      Regulatory.PackageExport.StatisticalFolderName=STATISTICAL DATA
      Regulatory.PackageExport.MediaFilesFolderName=MISC FILES
      Regulatory.PackageExport.MediaVideoFilesFolderName=Video Files
      Regulatory.PackageExport.MediaImageFilesFolderName=Image Files

    2. Set the names for the folders depending on your business requirements.
  4. To define the name of the PDF output file when a user publishes a submission dossier as a single file, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object:

      Regulatory.Submission.eCopySinglePDFName=Submission Dossier

    2. Set the name of the PDF file depending on your business requirements.
  5. To define how the ZIP files will be exported, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object:

      Regulatory.PackageExport.StatisticalZipFileName=Statistical Data
      Regulatory.PackageExport.MediaVideoFilesZipFileName=Video Files
      Regulatory.PackageExport.MediaImageFilesZipFileName=Image Files
      Regulatory.PackageExport.ZipFileName=ExportedObjectFiles

    2. Set the names of the ZIP files depending on your business requirements.
  6. When finished updating the text file with all properties you want to modify, including the ones shown here, use the text file to modify the Regulatory.properties page object. For more information, see Editing Properties Using MQL.
  7. To configure properties for generating PDFs, open the PDFRendering.xml file located in .../Apps/MarketRegistration/V6R2021x/Modules/ENOPDFRendering/AppInstall/Programs, then follow these steps:
    1. Add or edit these lines:

      <ApplicationSettings>
      <RenderPDF>true</RenderPDF>
      <AdlibJobManagementServiceMachineName>server_name</AdlibJobManagementServiceMachineName>
      <AdlibPdfVersion>adlib_version</AdlibPdfVersion>
      <MachineId>machine_id</MachineId>
      <AdlibServiceLocation>selfHosted_location</AdlibServiceLocation>
      <InputDirectory>input_dir</InputDirectory>
      <OutputDirectory>output_dir</OutputDirectory>
      <GenerateJobTicket>true</GenerateJobTicket>
      <RepositoryId>00000000-0000-0000-0000-000000000000</RepositoryId>
      <TransformationWorkspaceId>PDF_transformation_engine</TransformationWorkspaceId>
      <ComponentVersion>1.0.0</ComponentVersion>
      <RemoteInputDirectory>remote_input_dir</RemoteInputDirectory>
      <RemoteOutputDirectory>remote_output_dir</RemoteOutputDirectory>
      <ConsoleUsername>sysadmin</ConsoleUsername> 
      <ConsolePassword>sysadmin_password</ConsolePassword>
      <TOCPageLocation>Start\End\Empty</TOCPageLocation>
      <ApproversPageLocation>Start\End\Empty</ApproversPageLocation>
      <QRCodeLocation>Start\End\Empty</QRCodeLocation>
      <RenditionMode>individual</RenditionMode>
      <ActivationMode>automatic</ActivationMode>
      <ControlledPrintRenditionMode>individual</ControlledPrintRenditionMode>
      <RenditionTemplate>
            <Enabled>true\false</Enabled>
        <DefaultRenditionTemplate>
              <Name>Internal Tech Doc Template</Name>
              <Rev>0<Rev>
        <DefaultRenditionTemplate>
      </RenditionTemplate>
      <Type name="type_QualitySystemDocument" mode="DCL" ServiceType="WebService">
           <Service>Generic</Service>
      </Type>
      </ApplicationSettings>
      
      where:
      • <RenderPDF> </RenderPDF> specifies whether to render PDFs or not: true to render PDF files or false to not render PDF files. The default value is false.
      • server_name is the name of the Adlib host server. It can be the hostname or the IP address.
      • adlib_version is the version of Adlib installed on the server. For example, <AdlibPdfVersion>5.4</AdlibPdfVersion>.
        Note: Do not use a version with a second decimal point, such as <AdlibPdfVersion>5.4.1</AdlibPdfVersion>, because it will cause an error.
      • machine_id is the MachineId of the server where the Adlib PDF Enterprise software is installed. This information is stored in the initsettings.xml file that contains the Adlib-specific system information. This file is typically located at C:\Program Files\Adlib\Generic Connector\initsettings.xml. The machine_id is stored as the value of Adlib.Configuration.MachineId.
      • machine_id is the MachineId of the server where the Adlib PDF Enterprise software is installed. If you do not set this value, it is defined as all zeroes, which means the system will generate this value and it can change time the web service is restarted. We recommend that you generate a globally unique identifier (GUID) to use as the machine ID to ensure that a new machine ID is not generated each time the server is restarted.
      • selfHosted_location is URL where the Adlib service is self-hosted, for example: http://${ADLIB_JOB_MANAGEMENT_SERVICE_MACHINE}:51051/Adlib/JobManagementService/JobManagementService.svc. If you installed the IIS web server for Adlib, you do not need to change this value.
      • input_dir is the share drive directory location referenced by the 3DSpace server where the input files will be checked out to, for example: /Adlib/FolderConnector/AAIInput. Specify the path from root for Linux servers.
      • output_dir is the share drive directory location referenced by the 3DSpace server where the input files will be checked in from, for example: /Adlib/FolderConnector/AAIOutput. Specify the path from root for Linux servers.
      • <GenerateJobTicket> </GenerateJobTicket> specifies if a job ticket is generated.
      • <RepositoryId> </RepositoryId> is the repository ID.
      • PDF_transformation_engine is GUID of the Adlib server. The PDF_transformation_engine is stored as the value of TransformationWorkspaceId on the Adlib server.
      • <ComponentVersion> </ComponentVersion> specifies the component version.
      • remote_input_dir is the share drive directory location referenced by the Adlib Windows server for where to find the input files to be processed into PDF. This can be either a UNC path or a Windows path if a drive letter has been allocated to the share drive. For example, P:\FolderConnector\AAIInput
      • remote_output_dir is the share drive directory location referenced by the Adlib Windows server for where to place the output files to be processed into PDF. This can be either a UNC path or a Windows path if a drive letter has been allocated to the share drive. For example, P:\FolderConnector\AAIOutput
      • sysadmin is the username used to log in to the Adlib Management Console.
      • sysadmin_password is the password for the username used to log in to the Adlib Management Console.
      • <TOCPageLocation> </TOCPageLocation> is the location of the Table of Contents in the rendered PDF file: Start is at the beginning of the PDF file, End is at the end of the PDF file, or blank means that it is not included anywhere in the PDF file. Select only one option and remove the other two.
      • <ApproversPageLocation> </ApproversPageLocation> s the location of the Approvers table in the rendered PDF file: Start is at the beginning of the PDF file, End is at the end of the PDF file, or blank means that it is not included anywhere in the PDF file. Select only one option and remove the other two.
      • <QRCodeLocation> </QRCodeLocation> is the location of the QR code in the rendered PDF file: Start is at the beginning of the PDF file, End is at the end of the PDF file, or blank means that it is not included anywhere in the PDF file. Select only one option and remove the other two.
        Note: For more information on configuring the placement of the Approvers page, the Table of Contents, and the QR code in the rendered PDF file, see About Specifying Page Elements in a Rendered PDF File.
      • <RenditionMode> </RenditionMode> specifies if the PDF is consolidated into a single PDF or PDF is generated individually.
      • <ActivationMode> </ActivationMode> specifies if the PDF is generated manually or automatically.
      • <ControlledPrintRenditionMode> </ControlledPrintRenditionMode> specifies if the controlled print PDF is generated in a consolidated form or individually.
      • <RenditionTemplate> </RenditionTemplate> specifies if cover pages are enabled. If this setting is true, then cover pages are enabled with or with out enabling file categories. Once this entry is true, the Rendition Document Template tab is available for the Leader or Administrator. Then the PDF format cover page template files can be checked in for each rendition document template that is created. When file categories are enabled and the file categories are listed, the administrator can choose a category for each rendition document template. If an active rendition document template does not exist, the default rendition template is used. If file categories are disabled, but rendition template is enabled, the default rendition template is used whose Name and Revision are specified in the PDFRendering.xml. The first page after the Table of Contents is the cover page in the generated PDF file.
        Important: Restart the server after modifying the XML file.
      Note: You can find the TransformationWorkspaceId, and other important Adlib information, in the initsettings.xml file generated after the Adlib Generic Connector has connected to the Adlib server.

    2. Import the specified values into 3DSpace by running the following MQL command:

      mod page PDFRendering file …/Apps/MarektRegistration/R2020x/Modules/ENOPDFRendering/
      AppInstall/Programs/PDFRendering.xml;

    3. To verify that you have imported the file correctly, run the following MQL command:

      print page PDFRendering select content;