Why does AI in Regulatory Content Preparation Matter?
As artificial intelligence technology continues to evolve, its use cases in regulatory content preparation are becoming more and more common.
Global regulatory submissions demand high volumes of precise documentation, often in multiple languages and formats. The traditional methods of translation and redaction in regulatory content preparation typically involve significant manual effort.
In translation, human translators must not only understand the technical language but also ensure accuracy and quality of regulatory terminology across different languages. Similarly, manual redaction, which is essential for ensuring sensitive information remains confidential, can be prone to human error, leading to potential compliance risks.
These processes are also labor-intensive, requiring a considerable investment of time and resources.
How Does DocShifter’s Automation Come in Play?
DocShifter integrates AI for translation and redaction as optional steps within its broader content automation workflows.
Imagine that you have a clinical study report in Microsoft Word, and you want to create a PDF out of it for inclusion in a dossier. You can take a DocShifter workflow to create multiple translation versions of the same document as part of the whole automation.
The software is designed to be flexible and adaptable, allowing it to integrate seamlessly with various content management systems (CMS) and document repositories such as Veeva, Documentum (DCMT), SharePoint (SP), Ennov, CARA, LORENZ, and others.
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AI-Powered Translation with DocShifter
DocShifter uses AI models to automate the translation of documents within an existing workflow. When content is processed (e.g., a Word or PDF document), AI translation can be triggered as part of the overall content lifecycle.
You have full control over when a translation is triggered, just like any other automated steps we can perform (conversion, validation, etc.)
See how it can be part of your content lifecycle:
AI-Powered Redaction with DocShifter
DocShifter also includes AI-powered redaction capabilities, which are crucial for protecting sensitive information within any documents’ type: clinical, quality, regulatory, etc.
This is important for documents that need to be shared publicly or submitted to health authorities, where certain information must be hidden for compliance purposes.
Future of AI in Regulatory Content Preparation
The role of AI in regulatory content preparation is expected to continue evolving. While translation and redaction are the most prominent applications today, AI’s potential extends beyond these tasks.
Future developments may include enhanced tools for document validation, compliance checks, and automated generation of submission-ready content.
AI could also help identify trends and insights from historical regulatory data, enabling teams to make more informed decisions in future submissions.
