o OCR software converts files into text-searchable documents, aiding pharmaceutical companies in abiding by FDA guidance.

Ensuring Documents Comply With OCR Regulations for CBER and CDER Submission

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Optimizing PDF files before submitting them to the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER) is highly advised by the FDA. Recommendations from the FDA include ensuring your PDF files are text-searchable and utilizing PDF compression for faster transmission, download and open speeds. By integrating OCR software and a PDF compressor software into document processing workflows, pharmaceutical companies abide by FDA guidance.

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. By integrating OCR software into document processing workflows, companies can automate the process of converting documents to text-searchable PDF files.

While digitally born PDF files are already typically text-searchable, image documents such as scanned paper, mobile pictures of physical documents, faxes, and others require OCR to be submitted. This benefits pharmaceutical companies since the FDA advises against submitting PDFs of scanned paper documents without the ability to perform keyword search. Resizing scanned documents can decrease the font to a size below the size recommended by the FDA, and a simple scanned document does not contain a usable table of contents, either, which is also recommended by the FDA. Adding a table of contents to a scanned document is unfeasible unless the document is first rendered text-searchable with OCR software.

File Compression to Reduce PDF Size

Compressing PDF files abide by FDA guidance on reducing file size and optimizing the resolution of scanned documents. However, while plenty of online PDF compression software solutions exist, many are limited in capability and efficiency.

Unlike online PDF compression tools with daily compression limits and that can only compress one document at a time, CVISION’s PDF Compressor utilizes batch processing, multi-threading, and other options to 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, but 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. CVISION’s PDF Compressor typically reduces PDF size by a factor of 5-10x for black and white scans and by a factor of 10-100x for color scans. Therefore, organizations do not have to limit themselves to black scans only and can preserve color documents more effectively with more robust PDF compression software.

Pharmaceutical companies can successfully comply with FDA guidance by incorporating OCR and PDF compression software into their daily document processing workflows. If your organization needs reliable, high-volume conversion of documents to an FDA-compliant format, get started with your free trial of PDF Compressor today!

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