Life Science — Regulatory Document Generation for Clinical Data

Overview

The primary 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) from clinical data and analysis results. By leveraging predefined document templates, this workflow streamlines the documentation process, ensuring that all generated documents are compliant with regulatory standards. The architecture comprises multiple data sources, including clinical trial data, laboratory results, a

The primary 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) from clinical data and analysis results. By leveraging predefined document templates, this workflow streamlines the documentation process, ensuring that all generated documents are compliant with regulatory standards. The architecture comprises multiple data sources, including clinical trial data, laboratory results, and regulatory guidelines, which are ingested into the system for processing. The ingestion pipeline begins with the collection of clinical trial data from various sources, followed by data validation to ensure accuracy and completeness. Next, the data is transformed according to the specified document templates, where processing logic applies necessary formatting and compliance checks. Quality controls are integrated at each stage to maintain data integrity and adherence to regulatory requirements. Once the documents are generated, they are stored in a document management system, facilitating easy access and retrieval for regulatory audits and compliance checks. Key performance indicators (KPIs) for monitoring this process include the accuracy of generated documents, time taken for document generation, and compliance rates with regulatory standards. The business value of this DAG lies in its ability to significantly reduce the time and resources required for document generation, thereby accelerating the regulatory submission process and enhancing overall operational efficiency in the life sciences sector.

Part of the Predictive Maintenance solution for the Life Science industry.

Use cases

• Reduces time spent on manual document preparation
• Enhances compliance with regulatory standards
• Improves accuracy of generated documentation
• Facilitates faster regulatory submissions
• Streamlines access to critical documents for audits