We released a new version of eCTD Support tools “PharmaDoc eCTDSupporters 7.1”

New Functionalities

  • Simplified Chinese characters are now supported. Simplified Chinese can be selected for display and output languages.
  • Adobe Acrobat 64-bit version is now supported.

Improvements

  • The check rules for the Bookmark/Link Destination Check Tool have been extended according to the eCTDv4.0 leaf file specification.
    Launch actions that refer to files of a specified type are now allowed.
  • Check rules set in the Destination Check Tool can also be used in the Destination Edit Tool.
  • The language setting can now be explicitly set to a language different from the Acrobat display language setting.

PharmaDoc eCTDSupporters is currently used by 34 pharmaceutical companies and CROs (signed as an annual license agreement).

Please refer to the page of PharmaDoc eCTDSupporters for details.

We released a new version of Leaf files quality checking tool “PharmaDoc LeafChecker 6.1”

New Functionalities

  • Simplified Chinese characters are now supported. Simplified Chinese can be selected for display and output languages.
  • Adobe Acrobat 64-bit version is now supported.

Improvements

  • Added pop-up warning message when Acrobat’s protected mode is turned on.
  • In our recommended eCTDv4.0 rule sets, we have added underscores to the allowed characters in folder names.
  • In response to the removal of forms from the eCTD Validation Tool’s [PDF Annotation Check], the [Forms] check item has been unchecked from our recommended check pattern.
  • Fixed a problem in which the setting not to point out corrupted objects (CorruptedObject_Check=false) was not enabled.
  • Fixed a problem in which the symbol in the result column of the summary report would be “-” if the link string was a single character and an excluded character.
  • The standard bundle of PharmaDoc Quicker has been removed.

Please refer to the page of PharmaDoc LeafChecker for details.

We have released a new version of rendition server “PharmaDoc Generator 5.3”

New Features

  • eCTD v4.0 has been supported.
    JPEG2000 can be specified as the compression method for image data in rendition PDF files.
  • Office2021 has been supported.
  • Web management application functions have been enhanced.
    Log files can be viewed from the administration screen.
    Configuration files can be edited from the administration screen.

Improvement

  • Fixed the bug that prevented the creation of heading bookmarks for paragraphs containing style breaks has been addressed.

Please refer to the page of PharmaDoc Generator for details.

We have released a new version of create final redacted version tools "PharmaDoc Redact 4.0"

New Feature

  • The “Convert Annotation to Mark” function allows you to convert a Highlight annotation to a Redaction annotation. You can also specify the replacement string and reason.

Improvements

  • The folder selection dialog has been redesigned for ease of use.
  • The reason can now be specified by date on the Batch Marking dialog.
  • The pull-down menus for the replacement string and reason for the Redaction Style can now be edited.
  • Preferences > Justification Table for Redaction Proposal Version > The initial value of the top and bottom edge of the Trimming Range has been changed from 7mm to 2mm.
  • Fixed a problem that prevented AnnotationX from uploading the redaction annotations added by Redact.
  • Asterisks at the end of replacement strings are now replaced with “*” (six lines) characters.
  • Since it is not possible to create a Final Redacted Version from Redaction Proposal PDF, the message “It is not possible to create the Redaction Proposal Version or the Final Redacted Version from the Redaction Proposal PDF” is displayed.
  • Windows 11, Microsoft Word/Excel 2021 are supported.

Please refer to the page of PharmaDoc Redact for details.

We released a new version of Leaf files quality checking tool "PharmaDoc LeafChecker 6.0"

New Functionalities

  • eCTDv4.0 Support
    – An [ICC profile] check item that points out if an image does not have an embedded ICC profile has been implemented.
    – Rule set for eCTDv4.0 and eCTDv3.2.2 are available.
    – Launch link action to CDISC files (.xpt) is not detected.
    – Annotated Case Report Form (Annotated CRF) are not detected even if annotations are added.
  • Added items
    – Bookmark Destination Coordinates, Link Destination Coordinates: Detects the destination if it is outside of the right end bottom page.
    – Image: Detects an image.

Improvements

    • Windows 11 and Microsoft Excel 2021 are now supported.
    • The folder selection dialog has been redesigned for ease of use.
    • Folders can now be checked without including subfolders when checking by folder specification.
    • In the LeafChecker dialog, it is now possible to select whether or not to annotate each item. You can specify items that require annotations.
    • The maximum number of annotations per page can be set for each item.
    • Results can be output to the same folder as the check target.
    • The existence or non-existence of remarks can be indicated at the end of the check. A button to open a summary report has been added.
    • The result folder can be specified and checked again under the same conditions.

Please refer to the page of PharmaDoc LeafChecker for details.

We released a new version of rendition server “PharmaDoc Generator 5.2”

New Feature

  • Documentum 21.4 has been supported.
  • The owner can be changed to the publish requester when registering a PDF file for the Publish option(CARA Linkage Option).
    This feature enables the publish requester to easily search and view published documents from CARA’s web screen.

Improvements

  • Fixed the bug that CARA Linkage Service error caused when a long string was specified for the version label of a document.

Please refer to the page of PharmaDoc Generator for details.

We released a new version of rendition server “PharmaDoc Generator 5.1”

New Feature

  • CARA 5.6 is supported.

Improvements

  • External characters can be used in the Windows service version.
  • Added the process to perform direct print processing when background printing does not start when performing PostScript printing.
  • Added the process to restart the OS when the DB status error is detected.
  • Updated log4net to ver2.0.13.
  • Fixed the bug that the log file monitoring function does not work normally.
  • Fixed the rendition error after applying Office updates.

Please refer to the page of PharmaDoc Generator for details.

We released a new version of the shared review system “PharmaDoc AnnotationX 3.0” and “PharmaDoc Reviewer 5.5”

New Functionalities

  • Connected to CARA, a document management system.
  • Added administrative functions such as downloading PharmaDoc AnnotationX logs and system monitoring.

Improvements

  • Windows 11 and Excel 2021 are supported.
  • Documentum 21.4 is supported.
  • The system requirements are changed.

Please refer to the page of PharmaDoc AnnotationX and PharmaDoc Reviewe for details.

We released a new version of eCTD Support tools “PharmaDoc eCTDSupporters 7.0”

Improvements

  • The Bookmark Edit Tool has been completely redesigned, with enhanced editing functions such as sorting and automatic hierarchy setting.
    In addition, it has a batch creation function from PDF text or table of contents pages.
  • Added the following functions to the eCTD Batch Setting Tool: “Change Destination to Page Top”, “Replace PDF Properties”, “Delete Off-Page Objects”, “Delete Hidden Text”, “Delete Named-Destination” and “Delete PDF Tag Information”.
  • The UI of the preview screen of the destination tool has been changed to improve readability and operability.
  • An assistant dialog is provided to help you visually set the margins.
  • Added full support for shortcut key operations.
  • The location of the user configuration file has been changed to improve the convenience of remote login.
  • A button to initialize user settings has been added to make it easier to take action when a trouble occurs.
  • High-resolution display is now supported.
  • Windows 11 is now supported.

PharmaDoc eCTDSupporters is currently used by 34 pharmaceutical companies and CROs (signed as an annual license agreement).

Please refer to the page of PharmaDoc eCTDSupporters for details.

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