Ensuring FDA Submission PDF Compliance with Adobe Acrobat, Mapsoft Bookmarker, and Mapsoft TOCBuilder

Creating FDA-compliant PDFs for submissions involves adhering to specific guidelines to ensure that documents are readable, searchable, and navigable. Using Adobe Acrobat in conjunction with Mapsoft Bookmarker and Mapsoft TOCBuilder can streamline this process. Here’s a detailed guide on how to use these tools together effectively.

Understanding FDA PDF Requirements

The FDA specifies several key requirements for PDF submissions as outlined in their Portable Document Format (PDF) Specifications:

  1. Text Searchability: PDFs must be text-searchable.
  2. Navigation: Include a hypertext-linked Table of Contents (TOC) and bookmarks.
  3. Font Embedding: All non-standard fonts must be embedded.
  4. Security: PDFs must not have security settings or password protection.
  5. Initial View Settings: Set the initial view to open with the bookmarks panel and page.

Using Adobe Acrobat

Adobe Acrobat provides essential features for preparing and verifying your PDF’s compliance with FDA requirements:

  1. Ensuring Text Searchability:
    • Use Acrobat’s OCR feature to convert scanned documents into text-searchable files. Perform text searches within the document to ensure all text is searchable.
  2. Embedding Fonts:
    • Check and embed any non-standard fonts to ensure the document displays correctly on any device. Navigate to File > Properties > Fonts to see the list of fonts and embed them if necessary.
  3. Setting Initial View Settings:
    • Set the initial view to open with the bookmarks panel and page. Go to File > Properties > Initial View and adjust the settings accordingly.
  4. Disabling Security Settings:
    • Ensure no security settings or password protection are enabled. Verify this under File > Properties > Security.

Using Mapsoft Bookmarker

If your document does not already have bookmarks, Mapsoft Bookmarker is the tool to use next. This tool automates the creation and management of bookmarks, which are essential for a well-structured TOC.

  1. Creating Bookmarks:
    • Open your PDF in Adobe Acrobat and use the Mapsoft Bookmarker tool to generate bookmarks based on the document’s headings.
    • Organize these bookmarks hierarchically to reflect the document’s structure, ensuring easy navigation for reviewers.
  2. Organizing Bookmarks:
    • Arrange bookmarks in a logical hierarchy, with main sections and subsections properly nested. This organization is crucial for creating a clear and navigable TOC.

Using Mapsoft TOCBuilder

Once your document has the necessary bookmarks, Mapsoft TOCBuilder helps create a structured TOC for your PDF documents.

  1. Creating a TOC:
    • Open your PDF in Adobe Acrobat and navigate to the Mapsoft submenu under Plug-Ins.
    • Select TOCBuilder, which opens a configuration window where you can define the structure of your TOC.
  2. Defining Levels:
    • Specify multiple levels for your TOC to reflect the hierarchy of your document’s bookmarks. Configure each level’s font, size, color, and indentation to ensure clarity and a professional appearance (Mapsoft) (Mapsoft).
  3. Hypertext Links:
    • TOCBuilder automatically links TOC entries to the corresponding pages in the PDF, allowing for seamless navigation. This feature ensures that reviewers can quickly locate relevant sections within lengthy documents (Mapsoft).

Combining the Tools for FDA Compliance

By integrating the functionalities of Adobe Acrobat, Mapsoft Bookmarker, and Mapsoft TOCBuilder, you can efficiently create FDA-compliant PDF submissions:

  1. Prepare and Verify with Adobe Acrobat:
    • Ensure text searchability, embed necessary fonts, set initial view settings, and confirm the absence of security restrictions.
  2. Add and Organize Bookmarks with Mapsoft Bookmarker:
    • Use Bookmarker to create and organize bookmarks that define the structure of your document.
  3. Create and Structure the TOC with Mapsoft TOCBuilder:
    • Use TOCBuilder to generate a hyperlinked TOC that mirrors your document’s bookmark hierarchy.

Conclusion

Ensuring your PDF submissions are FDA-compliant can be straightforward with the right tools. Adobe Acrobat, Mapsoft Bookmarker, and Mapsoft TOCBuilder together offer a robust solution for creating, organizing, and finalizing your PDFs to meet FDA standards. By leveraging these tools, you can streamline the submission process and enhance the readability and navigability of your documents, ultimately facilitating a smoother review process.

For more detailed information on these tools, you can visit the Mapsoft TOCBuilder page and the Mapsoft Bookmarker page. You can also refer to the FDA’s PDF Specifications for comprehensive guidelines.