Life Science — Regulatory Document Management Automation
PopularThis DAG automates the management of regulatory documents and associated deliverables, ensuring compliance and traceability. It integrates extraction and validation processes to streamline documentation workflows in the life sciences sector.
Overview
The Regulatory Document Management Automation DAG is designed to optimize the handling of regulatory documents within the life sciences industry, focusing on governance and compliance. Its primary purpose is to automate the extraction, validation, classification, and archiving of regulatory documents according to specific standards. The data sources include regulatory submissions, internal standard operating procedures (SOPs), and compliance checklists. The ingestion pipeline begins with the col
The Regulatory Document Management Automation DAG is designed to optimize the handling of regulatory documents within the life sciences industry, focusing on governance and compliance. Its primary purpose is to automate the extraction, validation, classification, and archiving of regulatory documents according to specific standards. The data sources include regulatory submissions, internal standard operating procedures (SOPs), and compliance checklists. The ingestion pipeline begins with the collection of these documents, followed by a series of processing steps that involve automated validation against predefined criteria, version control implementation, and access management to ensure traceability. Quality controls are embedded throughout the process, ensuring that all documents meet compliance requirements before being archived. The outputs of this DAG include updated SOPs, compliance reports, and documents stored in document management systems. Monitoring is facilitated through key performance indicators (KPIs) such as processing time and document compliance rates, which provide insights into workflow efficiency and adherence to regulatory standards. The business value of this automation lies in reducing manual labor, minimizing compliance risks, and enhancing the overall efficiency of regulatory documentation management.
Part of the Governance & Compliance solution for the Life Science industry.
Use cases
- Reduces manual effort in document management processes
- Enhances compliance with regulatory standards and requirements
- Improves traceability and accountability of documentation
- Speeds up the review and approval process for regulatory submissions
- Facilitates better resource allocation and operational efficiency
Technical Specifications
Inputs
- • Regulatory submissions from clinical trials
- • Internal standard operating procedures (SOPs)
- • Compliance checklists and guidelines
- • Audit trails from previous documentation
- • User access logs for document security
Outputs
- • Updated standard operating procedures (SOPs)
- • Compliance reports for regulatory authorities
- • Archived regulatory documents in document management systems
- • Version-controlled document repositories
- • Audit-ready documentation packages
Processing Steps
- 1. Collect regulatory documents from various sources
- 2. Validate documents against compliance criteria
- 3. Implement version control for document tracking
- 4. Manage access rights for document security
- 5. Generate compliance reports and update SOPs
- 6. Archive documents in the document management system
Additional Information
DAG ID
WK-1474
Last Updated
2025-06-04
Downloads
75