Scanning, a Thing of the Past

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Nowadays the word “scan” is a bad word.   Scanned documents are more difficult to read and often the quality is lower. Further, scanned documents do not allow search or copy and paste text.  During an electronic review, the ability to search and cut and paste text are very useful. Sponsors are reporting more and more rejections if scanned documents are submitted.

What should be done?

Ideally, submission documents should be text-based portable document format (PDF), meaning created directly from an electronic source such as Word. The PDF specifications encourage users to avoid scanning documents or embedding scanned documents. If you must have a scanned document, use an Optical Character Recognition (OCR) tool.  This will ensure the PDF is searchable.

As a very last resort, if you only have paper copy and must scan your document, it should be scanned at a resolution that will ensure the pages are clean and legible both on the computer screen and when printed. A common suggestion and practice is to scan at a resolution of 300 dots per inch (dpi), to provide legibility and to generate an electronic file size that is not too large. A few other considerations are to scan gels, photographs and karyotypes (the visual appearance of chromosomes) directly, rather than from a copy or photograph.  Due to color and the nature of these items, scanning is typically done at 600 dpi and 8-bit gray-scale depth, to achieve satisfactory quality.

Finally, it is recommended to use only fillable forms, not scanned forms. For past readings related to this topic, please see past posts.

Author: Rob Labriola

Rob Labriola has 20 years experience in regulatory operations for the pharmaceutical industry. Mr. Labriola has seen it all and truly understand the frustrations and rewards of moving to eCTD. He has worked on multiple application types (INDs, NDAs, BLAs, CTAs, NDSs, JNDAs and MAAs), and has extensive international experience, having submitted applications to the FDA, Canada, Europe, Switzerland, Australia, Israel, Japan, etc.

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