Innovation to Simplify Complex Regulatory Processes

A track record of innovation has vaulted Synchrogenix's GlobalSubmit PUBLISH solution to the top tier of the electronic common technical document (eCTD) publishing market. Foremost among the enhancements we've made to the status quo is a big picture process improvement that greatly reduces the number of steps a regulatory professional must perform to arrive at a validated, high-quality output.

Live Validation functionality is the innovation driving single instance output processing. Being able to identify and correct errors in real time, and then publish only the changes, is a tangible advantage as regulatory departments race to meet deadlines and deliver treatments to patients. The ability to auto process regulatory compliant PDF documents is another major innovation in PUBLISH. 

More Efficient PDF Document Publishing and QC

PDF publishing tasks, such as adding external and internal hyperlinks, and performing QC of bookmarks and hyperlinks, account for 80% of the time spent on eCTD compilation. Synchrogenix's GlobalSubmit CROSSCHECK and LINK tools, both found within the PUBLISH system, are designed to facilitate these actions, which are absolutely necessary if sponsors want to create high-quality, compliant submissions in a more efficient manner.   

CROSSCHECK

Independent tests show that CROSSCHECK is 8X faster and 3X more accurate when compared to traditional, manual methods of hyperlink and bookmark QC. CROSSCHECK displays a link source and destination side-by-side for quick, easy review. This innovation expedites an activity that accounts for 40% of working time when building an eCTD submission. 

LINK

LINK streamlines user workflow by cutting out at least four publishing tasks per document. Without exiting the PUBLISH interface to access a third party tool, users can set PDF document properties, create bookmarks and hyperlinks, and apply headers and pagination. Document updates can then be processed in bulk at industry leading speeds. 

 

Auto Process Regulatory Compliant PDFs

Synchrogenix's GlobalSubmit PUBLISH eliminates tens of thousands of routine, annual publishing tasks while ensuring 100% regulatory compliant PDF documents through auto processing. When the option to automatically process PDF documents according to regulatory compliant settings is turned on, the system only produces compliant PDFs. Time savings are realized as manual, pre-publishing tasks previously performed by the user are now executed by the system. 

Regulatory compliant PDF properties include: 

  • Set Navigation to Bookmarks Panel and Page
  • Embed All Fonts
  • Inherit Zoom for Bookmarks and Hyperlinks
  • Flatten Annotations (excludes hyperlinks) 
  • Set Fast Web Access

 

Benefits

Performance

Intuitive functionality, user-friendly interface plus fast processing. Multi GB submissions "publish out" in a matter of minutes. The system only processes deltas or changes. 

Compliant with Internal QC Standards

All edits occur within audit trails; trails are not broken by accessing the copy folder. 

Industry Leading Validation Engine

Interpretation of technical errors, and presentation of submission content is identical to the FDA. 

Study Tagging Files

Automatically created based on information supplied about the study and its documents. 

Effectively Manage Hyperlinks

Move PDF documents from one section to another without breaking external hyperlinks. 

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