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Medical Writing QC Automation

Accelerate Accuracy and Compliance in Medical Writing with Smart QC Automation

Medical writing teams face relentless pressure to deliver high-quality regulatory and scientific documents – faster and with zero errors. From clinical summaries to SOPs and training manuals, even the slightest formatting inconsistency or QC oversight can lead to rework, delayed submissions, or compliance failures.

DDi’s QC Automation platform for medical writing brings structure, speed, and precision to your authoring and review workflows – using intelligent automation that eliminates manual bottlenecks and minimizes human error.

Why QC Automation Matters in Medical and Non-Clinical Writing

In both clinical and non-clinical document development, formatting is more than visual polish – it’s a compliance and quality imperative. Medical writers spend significant time on repetitive formatting and QC tasks, such as aligning tables, checking references, verifying headers, and ensuring style guide adherence.

These tasks, although non-creative, are critical. When handled manually, they result in:

  • High error rates due to fatigue and inconsistency
  • Delays from repetitive document revisions
  • Regulatory risks from missed formatting/QC standards

That’s where automation steps in – not to replace writers, but to supercharge their productivity and ensure quality at scale.

Ready to Modernize Your Medical Writing QC Workflow?

Let your writers focus on science and content – leave the repetitive formatting and QC to us. With DDi, you’ll reduce cycle times, improve quality, and never miss a compliance detail again.

What DDi’s QC Automation Platform Delivers

Automated Formatting Compliance

Our automation engine enforces predefined style templates, adjusts headings, aligns tables, and ensures consistent application of margins, fonts, and spacing – all without manual intervention.

Real-Time Quality Checks

AI-assisted QC continuously scans documents for:

  • Inconsistent headers
  • Improper nested bullets or lists
  • Broken cross-references
  • Mismatched figure/table numbers
  • Missed regulatory placeholders

Rule-Based Validation Engine

Build custom validation rules based on regulatory requirements, client-specific styles, or therapeutic area preferences. Automate the review of citation formatting, glossary usage, page numbering, TOC structure, and more.

Multi-Document Batch Processing

Automate formatting and QC across hundreds of documents – ideal for large CTD submissions or standardized SOP repositories.

How Automation Transforms the QC Process

Based on best practices from the field of non-clinical writing automation, key benefits include:

Significant Time Savings

What normally takes hours - like rechecking table placements, updating revision histories, or correcting style inconsistencies - can be executed in minutes.

Increased Accuracy

Automation applies QC rules consistently and without fatigue, reducing human errors and improving document reliability.

Compliance Assurance

Meet global health authority standards (e.g., FDA, EMA, PMDA) by enforcing formatting norms and structural integrity. Avoid audit findings and submission rejections due to formatting discrepancies.

Scalable Across Teams

Whether you're authoring SOPs, training manuals, or regulatory narratives, our QC automation can be tailored to match your internal templates, language requirements, and content structure.

Built for Regulatory & Quality Demands

Our platform aligns with industry compliance expectations including:

  • 21 CFR Part 11
  • Corporate SOP documentation standards
  • Regulatory writing submission guidelines (eCTD, ICH)

We also support integration with platforms like smartDOC, PerfectIt, and MS Word macro systems to enhance document consistency across geographies and teams.

Ready to Modernize Your Medical Writing QC Workflow?

Let your writers focus on science and content - leave the repetitive formatting and QC to us. With DDi, you'll reduce cycle times, improve quality, and never miss a compliance detail again.

Talk to us today about how to implement automated QC into your document lifecycle

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