Life Science — Automated Regulatory Document Generation Pipeline

Overview

The primary purpose of this DAG is to automate the generation of regulatory documents essential for compliance in the life sciences sector. It begins by extracting necessary data from various internal systems, such as clinical trial databases and regulatory compliance systems. This data is then validated for accuracy and compliance with industry standards. The ingestion pipeline employs a series of transformation steps, including data cleansing, formatting, and mapping to predefined document tem

The primary purpose of this DAG is to automate the generation of regulatory documents essential for compliance in the life sciences sector. It begins by extracting necessary data from various internal systems, such as clinical trial databases and regulatory compliance systems. This data is then validated for accuracy and compliance with industry standards. The ingestion pipeline employs a series of transformation steps, including data cleansing, formatting, and mapping to predefined document templates. Once the documents are generated, they undergo rigorous quality control checks to ensure they meet regulatory requirements. The outputs of this process include finalized regulatory documents stored in a secure format, ready for submission to regulatory bodies. Key performance indicators (KPIs) for monitoring this workflow include the time taken for document generation and the compliance rate of the produced documents. By streamlining the documentation process, this DAG significantly reduces the time and effort required to produce compliant documents, enhancing operational efficiency and minimizing the risk of non-compliance. The business value of this automation lies in its ability to ensure timely submission of documents, reduce manual errors, and improve overall compliance in the life sciences industry.

Part of the Data & Model Catalog solution for the Life Science industry.

Use cases

• Reduces time spent on document preparation and submission
• Minimizes risk of non-compliance with regulatory standards
• Enhances accuracy through automated data validation
• Improves operational efficiency in document management
• Facilitates timely responses to regulatory inquiries