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Using the Muhimbi PDF Converter to generate FDA / eCTD valid documents

Posted at: 11:53 on 27 July 2015 by Muhimbi

FDAOur popular PDF Converter for SharePoint and PDF Converter Services (for Java, C#, PHP, Ruby), as well as the PDF Converter for SharePoint Online / Office 365 is used in almost any imaginable industry. Local and federal government, financial industry, retail, engineering, space exploration etc. Some of these industries have pretty strict requirements when it comes to submitting or archiving documents.

One of the industries that specify such requirements is the U.S. Food and Drug Administration (FDA). In their specifications for Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications they list the following requirements. 

  • PDF versions 1.4 through 1.7, PDF/A-1 and PDF/A-2: We support all these versions, and more, and can even convert existing PDF files to PDF 1.1 – 1.7 as well as PDF/A1b & A2b for long term archiving.
  • Do not activate security settings or password protection: Although we support a range of PDF Security, Restriction and encryption facilities. The FDA’s recommendation is to not apply any security to the generated documents.
  • Fully embed all non-standard fonts:  Embedding or stripping of embedded fonts is fully supported by our software. Even better, just use PDF/A output which automatically takes care of most requirements.
  • Avoid image-based PDF files whenever possible: Image based content can be hard to read on screen and – even worse – is not searchable. As a result people cannot copy its contents or find it using whatever search engine they happen to use. When dealing with image based content such as scans and faxes, use our Optical Character Recognition (OCR) abilities to automatically recognise all text and include it in the PDF file.
  • Optimize the PDF for fast web view: Many PDF files are accessed via the internet. To prevent long downloads, PDF files can be Linearized / Optimised for fast web view. This reduces the loading time of the initial pages considerably.
  • Table of contents (TOC): The ability to merge multiple files is probably the second most used feature provided by our software. However, the result of a merge operation may result in a document that is hundreds of pages long, which can make navigation a bit difficult. Our software automatically adds PDF bookmarks to ease navigation, but even better can automatically generate a full featured Table Of Contents.
  • Initial View Settings: Making sure that the PDF is displayed in the most optimal manner when the document is opened removes the effort from the end user and reduces the need for training. Naturally we fully support this
  • Page Numbering: Especially in large documents, page numbering is extremely important. Most documents already contain page numbers, but when merging multiple documents together these page numbers do not reflect the reality. Use our extensive watermarking facilities to automatically calculate and display page numbers

If you have any questions then please leave a comment below or contact our friendly support desk, we love to talk to our customers.

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