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

September 9, 2014

3 minute read

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 PDF.

Meet us at DIA EDM and ERS 2014

Along with Adlib, we will be exhibiting at the upcoming DIA EDM and ERS 2014 conference. Visit our booth #404 (we’ll be right next to Adlib!), where you can see a number of product demos to help Life Sciences organizations improve their document workflows and automate tedious business processes such as generating compliant PDFs for eCTD submissions.  We will show you how to use a series of MS Word templates and SharePoint to enhance your ability to produce the documents necessary for the submission process.   Our qualified hosting environment - called RegDocs365 - utilizes SharePoint sites configured for the DIA EDM reference model and electronic Trial Master File (eTMF), Templates supplied by Sage Submissions and Adlib Enterprise PDF rendering products give you  everything you need to publish and submit your documents.  For more details on this event, visit the event page.

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