The overall quality of deliverables authored from eCTD templates is vastly improved compared to submission documents written from scratch. Advantages of originating submission documents using eCTD templates include:
- Documents follow the eCTD granularity requirement
- Format-as-you-go helpers such as customized toolbars allow for easy creation of styled headings
- Table of contents (TOCs)
- In-text cross-reference citations that automatically update with the correct destination as the document develops
In a recent article posted to the eCTD Summit titled “Hyperlinking: Making the Most of Navigation in eCTD Submissions,” I mentioned these advantages as well as PDF publishing conventions commonly implemented by regulatory operations publishing groups.
One reader pointed out that the use of eCTD templates and adherence to publishing conventions did not completely eliminate the need to perform time-consuming, manual publishing tasks once a document is rendered to PDF. The issue was presented as follows:
“When you use Word templates with styles and make use of the MS Word ‘cross-referencing’ option, tables, figures, sections, etc. within a given page all are automatically [linked] to their target destinations. However, when you have the same table cross referenced on the same page four (4) times, after rendition to PDF, you must manually break those three (3) extra links and convert the text from blue to black. Do you have this issue or is your EDMS customized to take care of this automatically?”
In short, the answer is yes. We do have this issue and are forced to manually remove unnecessary links and turn text black. We have to perform the same tasks manually when the cross reference and destination fall on the same page. GlobalSubmit’s regulatory operations team is in constant collaboration with our software developers to brainstorm innovative EDMS and publishing enhancements that will automate more tasks users currently perform manually. Future releases of GlobalSubmit products will allow users to automatically fix these issues when they occur within a PDF document.
We sincerely appreciate receiving feedback on our services and products, and are always seeking ideas that will result in performance improvement. I’d like to thank the reader who submitted this real life publishing issue, and I encourage those of you who routinely work with electronic regulatory submissions to do the same. Hopefully we can continue to find innovative solutions that streamline electronic submissions and facilitate ease of review throughout the regulatory and compliance process.