From PDFs to Components – How to Start with Structured Content

Every small change creates chaos when your source of truth lives in digital documents. One update to Intended Use can trigger dozens of edits across SOPs, risk tables, and IFUs. The result is duplication, errors, and unpredictable review cycles. This is why half of submissions still get rejected.

In this episode, we’ll show you how to break free from the PDF trap and take your first steps into structured content. You don’t need to overhaul everything at once. By starting small, you can prove value quickly and build the foundation for AI-ready, audit-ready submissions. 

Key Takeaways 

• How to run a content audit to quantify duplication and risk. 
• Simple ways to pilot your first component (e.g., Intended Use or Risk Summaries). 
• Practical methods to break down legacy SOPs, IFUs, and policies into reusable chunks. 
• Live examples of issues and what to do when you find them 
  • Resubmission of approved documents 
  • Referencing standards in the submissions 
  • Guidance on consistency in terminology 
• The 4 Rs of Audit preparedness - Resilience, Reliance, Rationalization, Realignment 
• A roadmap for scaling your discoveries into an enterprise-wide structured submission system. 

By the end of this episode, you’ll start building your playbook for modernizing your technical files, reducing duplication, and creating a clear path toward moving from unstructured documents to structured, componentized files that regulators, reviewers, and AI can trust. 

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