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PPP™ for FDA Dockets

Precise Page Positioning™ used for preparing Food and Drug Administration Dockets for electronic submission

The FDA requires specific formatting of regulatory submission in electronic format. Precise Page Positioning™ is used by pharmaceutical companies for preparing scanned images for FDA submission.

  • What is the requirement?
    Submitted FDA documents must comply with the specified criteria described in the publication of Guidance for Industry Providing Regulatory Submissions in Electronic Format -- General Considerations. FDA guide also details formatting requirements of scanned pages. One FDA criteria is that scanned pages must have a 1" margin all around, and should be submitted in PDF format.
     
  • What is the problem?
    Source documents for FDA submission originate from various places in research labs or organizations. Some of the source material is properly formatted and is captured in electronic format (MS Word, WordPerfect, etc.) that is easily adjusted to the required parameters. However, there are a large number of materials that are difficult, impossible or impractical to obtain in electronic format. In this case the document preparation department scans the images using a document scanner. Once scanned, the images require secondary image processing in order to make them suitable for regulatory compliance. Quality control and margin adjustment operations are among the FDA standard requirements.
     
  • The solution is Precise Page Positioning™ with RESIZE capability.
    After scanning, a general-purpose cleanup and quality control operation is performed with PPP™. The application is used for: deskewing, despeckling, edge cleanup, and image content detection Once cleaned and corrected, the images are processed by a secondary operation. In this step the user sets up an output canvas with a margin criteria in PPP™ - in this case 1" margin is used all around. The pages are then automatically processed and the detected image content is resized to fit within the set margins.
     
  • Cost justification
    PPP™ replaces a costly and inefficient manual process. In the existing workflow, operators use copy machines with reduction capability to produce proper margins (1") on a standard page. The reduced page is scanned and converted to PDF. PPP™ eliminates the manual labor, improves image quality and performs PDF conversion, thus providing a highly automated workflow with substantial labor cost savings.