How to Ensure that Documents Comply with OCR Regulations for CBER and CDER Submission

How to Ensure that Documents Comply with OCR Regulations for CBER and CDER Submission

It’s highly advised by the FDA to optimize PDF files before submitting them to the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER). Recommendations from the FDA include ensuring that PDF files are text-searchable, as well as utilizing PDF compression for faster transmission, download, and open speeds. By integrating an OCR and PDF compression software into document processing workflows, pharmaceutical companies can easily abide by FDA guidance and avoid potential compliance issues.

Enable Instant Keyword Search with OCR

Submitting text-searchable PDF files to the CBER or CDER ensures that the centers can efficiently navigate and review the submitted documents. Otherwise, the appropriate people won’t be able to easily access their data. For this reason, the FDA requires submitted PDF documents to be text searchable.

While digitally born PDF files are typically already text-searchable, image documents such as scanned paper, mobile pictures of physical documents, faxes, and others require OCR processing prior to submission. Following Electronic Common Technical Document (eCTD) specifications, the FDA cautions to avoid submitting image-based PDF files whenever possible, as they have poorer resolution and are more difficult to read, making them overall less useful for review. It’s advised to make scanned files text-searchable, so that reviewers can more easily search through the document or copy and paste the text.

Other eCTD recommendations include incorporating a usable table of contents, which scanned documents do not contain. Additionally, it’s unfeasible to add a table of contents to a scanned document without first rendering it text-searchable. By integrating OCR software into document processing workflows, companies can automate the process of converting documents to text-searchable PDF files, eliminating the need for manual labor and simplifying the work needed to meet FDA requirements.

File Compression to Reduce PDF Size

Scanned documents are notoriously large in file size, which can be a headache when trying to submit. Scanning at a low resolution doesn’t guarantee that the document will be legible both onscreen and when printed, and resizing scanned documents can decrease the font to a size below the size recommended by the FDA. Compressing PDF files is the best way to abide by FDA guidance on reducing file size and optimizing the resolution of scanned documents.

While plenty of online PDF compression software solutions exist, many are limited in capability and efficiency. For instance, many have daily compression limits and can only compress one document at a time. If you deal with high volumes of documents, you may want to look into getting a specialized PDF compression software. That being said, not all PDF compression software is made equal – look for features such as batch processing and multi-threading, as they enable rapid, automated, high-volume compression and conversion of non-compliant documents.

The FDA also warns that scanning with grayscale or color greatly increases the size of documents. However, if your documents consist of a lot of images, tables, and charts, scanning documents with black ink is an impractical way of reducing file size. Foxit’s PDF Compressor can typically reduce black and white scans by 5-10x, and color scans by 10-100x. Therefore, organizations do not have to limit themselves to black & white scans only, as they can easily preserve color documents more effectively using a robust PDF compression software.

By incorporating OCR and PDF compression software into their daily document processing workflows, pharmaceutical companies can successfully follow FDA guidance. Contact Us if you have any questions on how you can get your documents to meet compliance standards!

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