Life Science — Automated Regulatory Document Generation Pipeline

Overview

The Automated Regulatory Document Generation Pipeline is designed to streamline the creation of essential regulatory documents in the life sciences sector, specifically eTMF (electronic Trial Master File) and eCTD (electronic Common Technical Document). The primary purpose of this DAG is to convert structured data inputs into compliant documents, thereby enhancing operational efficiency and regulatory adherence. The ingestion pipeline begins with the collection of data from various sources, incl

The Automated Regulatory Document Generation Pipeline is designed to streamline the creation of essential regulatory documents in the life sciences sector, specifically eTMF (electronic Trial Master File) and eCTD (electronic Common Technical Document). The primary purpose of this DAG is to convert structured data inputs into compliant documents, thereby enhancing operational efficiency and regulatory adherence. The ingestion pipeline begins with the collection of data from various sources, including clinical trial databases, regulatory submissions, and document management systems. Once the data is ingested, it undergoes a series of processing steps that include data validation, formatting, and compliance checks. These steps ensure that all generated documents meet regulatory standards and maintain traceability to their original data sources. Quality controls are integrated throughout the process, allowing for real-time monitoring of key performance indicators (KPIs) such as document generation time and compliance rates. In the event of a failure during document generation, a recovery process is triggered to address issues promptly, ensuring minimal disruption to workflow. The final outputs of this DAG are the generated eTMF and eCTD documents, which are then stored in a centralized document management system for easy access and retrieval. By automating the document generation process, this DAG not only reduces manual effort but also enhances the accuracy and compliance of regulatory submissions, providing significant business value to life sciences organizations.

Part of the Scientific ML & Discovery solution for the Life Science industry.

Use cases

• Increased operational efficiency in document management
• Enhanced regulatory compliance and reduced risk of errors
• Faster document generation leading to quicker submissions
• Improved traceability of data sources for audits
• Streamlined workflows reduce manual intervention and costs