Guest post from Court Square Group: Compliant PDFs generated for eCTD/eCopy submissions

Having worked with a large number of life sciences organizations, we’re very familiar with the stringent compliance regulations for submitting documents to health authorities like the FDA. Even a simple error – such as a password-protected PDF file or a malfunctioning hyperlink – can cause health authority reviewers to lose valuable time and resources which in turn leads the life sciences company to take corrective action to get the review back on track under the review timelines. This is where we come in. Court Square manages Qualified Cloud environments for submission bundle packages including EDMS and eCTD packages integrated together.  

We work with the Adlib engine as the driver for all PDF conversions in preparation for eCTD, NeeS and eCopy electronic submissions.  We’re pleased to work with Adlib, leveraging our mutual expertise in the Life Sciences space to secure greater ROI and business efficiency for our customers.

Automating important document features

There are a number of important requirements for eCTD/eCopy submissions, which the FDA notes in guidance documents and specifications. While there are many requirements, here are ten which we find organizations often have trouble achieving:

 
1. PDF files must be in the range of file format 1.4 to 1.7
 
2. PDF files must be optimized for fast web view
 
3. All pages must have a minimum ¾” margin on the left side
 
4. All documents longer than 5 pages should have bookmarks; bookmarks should match the table of contents hierarchy up to four levels
 
5. All content references not located on the page of reference must be hyperlinked
 
6. All PDF files containing bookmarks must open to the Bookmark Panel and Page
 
7. All text must be searchable, and scanned documents have accurate Optical Character Recognition (OCR)
 
8. Non-standard fonts must be embedded
 
9. Page orientation should be correct for reading
 
10. The PDF must be an exact representation of the original document, which is usually a Microsoft Word file

While it may seem like a simple task to meet these requirements, when dealing with hundreds of thousands of pages, completing this task manually can lead to many cases of human error. By automating this process, organizations can eliminate any chance of human error, and allow knowledge workers to focus on their specialized jobs, not document formatting. This leads to an increased efficiency in the workplace. Based on these key considerations and difficulties thereof, we address some of these things – but that’s why we partnered with Adlib: in order to benefit from the requisite high-fidelity, enterprise features and automation they provide through Adlib Software.