Life Science — Automated Regulatory Document Generation Pipeline

Overview

The Automated Regulatory Document Generation Pipeline is designed to facilitate the creation of essential regulatory documents such as electronic Trial Master Files (eTMF) and electronic Common Technical Documents (eCTD). This DAG is triggered by updates in research data and new regulatory requirements, ensuring that the documentation process remains current and compliant. The primary data sources include internal databases housing research data and existing research documents, which are crucial

The Automated Regulatory Document Generation Pipeline is designed to facilitate the creation of essential regulatory documents such as electronic Trial Master Files (eTMF) and electronic Common Technical Documents (eCTD). This DAG is triggered by updates in research data and new regulatory requirements, ensuring that the documentation process remains current and compliant. The primary data sources include internal databases housing research data and existing research documents, which are crucial for accurate document generation. The ingestion pipeline begins with data extraction from these sources, followed by a validation step to ensure the integrity and accuracy of the information. This validation process is critical, as it guarantees that only high-quality data is utilized in document generation. Once validated, the system generates the required documents, incorporating traceability features to maintain compliance with regulatory standards. Quality control measures are embedded throughout the process to ensure that all generated documents meet the necessary compliance criteria. The final outputs of this pipeline are stored in a document management system that allows for regular audits and easy retrieval. Key performance indicators (KPIs) for monitoring include document generation time, compliance rate, and the number of successful audits. This automation not only reduces the time and effort required for document generation but also enhances compliance accuracy, ultimately providing significant business value by mitigating risks associated with regulatory non-compliance.

Part of the Supply/Demand Forecast solution for the Life Science industry.

Use cases

• Increased efficiency in document generation processes
• Enhanced accuracy and compliance with regulatory requirements
• Reduced risk of non-compliance penalties
• Streamlined audits and document retrieval for stakeholders
• Improved collaboration between research and compliance teams