Life Science — Regulatory Document Generation Workflow

Overview

The purpose of this DAG is to automate the generation of regulatory documents such as electronic Trial Master Files (eTMF) and electronic Common Technical Documents (eCTD) within the life sciences sector. The workflow begins by extracting relevant data from various sources, including clinical trial databases and regulatory compliance systems. The ingestion pipeline processes this data to create well-structured documents formatted according to regulatory standards. Key processing steps involve fo

The purpose of this DAG is to automate the generation of regulatory documents such as electronic Trial Master Files (eTMF) and electronic Common Technical Documents (eCTD) within the life sciences sector. The workflow begins by extracting relevant data from various sources, including clinical trial databases and regulatory compliance systems. The ingestion pipeline processes this data to create well-structured documents formatted according to regulatory standards. Key processing steps involve formatting the extracted data, integrating citations for traceability, and applying quality controls to ensure compliance with industry regulations. The output formats include DOCX and PDF, which are widely accepted for regulatory submissions. Monitoring key performance indicators (KPIs) such as document generation time and compliance rates allows for ongoing assessment of the workflow's efficiency. The business value of this DAG lies in its ability to reduce manual effort, minimize errors, and accelerate the document generation process, ultimately supporting faster regulatory approvals and enhancing operational efficiency.

Part of the Governance & Compliance solution for the Life Science industry.

Use cases

• Increases efficiency in regulatory document preparation
• Reduces risk of human error in document generation
• Enhances compliance with regulatory requirements
• Accelerates the submission process for approvals
• Improves traceability and audit readiness of documents