- PharmaDoc LeafChecker checks whether created leaf files are compliant with eCTD standards.
- The created leaf files will be checked for any problems that may arise when submitting them to the Pharmaceuticals and Medical Devices Agency (PMDA) on electronic Submission Gateway.
- <Main items that are checked when submitting to PMDA on electronic Submission Gateway>
- Whether there are JPEG 2000 compressed images
- Whether there are bookmarks that exceed a certain size
- The tool will identify the exact file and pages where deficiencies are located.
- The tool allows you to check all leaf files in a folder, just by designating a folder.
- Customers can create a configuration of checked items in different leaf files based on their needs.
Thus, they can check the quality of leaf files, just by designating the names of checked items, even without understanding the details of the checked items.
PharmaDoc LeafChecker is currently used at 28 pharmaceutical companies and CROs (under annual basic support contracts).
Check items for Leaf File
- Check result reports can now be exported to an Excel file. In the past, it was necessary to copy and paste the file path to open the Check Result Folder, Notification PDF, Notification Text, and Check Target PDF File, but now these can be opened with a click of an Excel cell. The traditional csv format can also be selected for export.
- At the time of export to an Excel file, the characters in the cells of check item which notification is added change to red to make a distinction.
- Web Link check item has been added. It detects web link locations such as http:// and https://.
- Preferences dialog has been added. The Date Format can now be in English, and the Length Unit can be selected from mm and inch. Export file names can also be changed. The file name for check target PDF and notification PDF used to be the same. This caused confusion as to which was the notification PDF when both files were opened. When you check m2.7.3.pdf, it now has “_check” at the end of their names, e.g., m2.7.3_check.pdf.
|PharmaDoc LeafChecker 5.1||– Windows 7, Windows 8, Windows 8.1, Windows 10|
|– Adobe Acrobat X, XI, DC 2015, 2017, DC Continuous|
|– Microsoft Excel 2010, 2013, 2016|
|– Microsoft .NET Framework 4.0, 4.5, 4.5.1, 4.5.2, 4.6, 4.6.1, 4.6.2, 4.7, 4.7.1|
|– Microsoft Visual C++ 2010 SP1 Redistributable Package (x86)|
PharmaDoc LeafChecker is available with an English or Japanese UI.
* PharmaDoc is a registered trademark of Planet Pharma Solutions, Inc. in Japan.
* LeafChecker is a registered trademark of Planet Pharma Solutions, Inc. in Japan.
* Acrobat® is a registered trademark of Adobe Systems Incorporated in the United States and /or other countries.