Life Science — Audit Trail Management for Regulatory Compliance

Overview

The purpose of this DAG is to ensure the effective management of compliance audit trails for regulatory data and documents within the life sciences industry. It begins with the collection of access logs from various data sources, including laboratory information management systems (LIMS), electronic lab notebooks (ELN), and regulatory document repositories. The ingestion pipeline captures these logs in real-time, facilitating immediate validation of any modifications made to sensitive documents.

The purpose of this DAG is to ensure the effective management of compliance audit trails for regulatory data and documents within the life sciences industry. It begins with the collection of access logs from various data sources, including laboratory information management systems (LIMS), electronic lab notebooks (ELN), and regulatory document repositories. The ingestion pipeline captures these logs in real-time, facilitating immediate validation of any modifications made to sensitive documents. The processing steps involve validating changes against predefined compliance rules, applying security controls to protect sensitive information, and generating detailed audit reports that summarize access and modification activities. Quality controls are integrated throughout the process to ensure data integrity and compliance with industry regulations. The outputs include comprehensive audit reports, incident tracking logs, and compliance dashboards that provide key performance indicators (KPIs) such as the number of incidents and response times. Monitoring these KPIs allows organizations to quickly identify and address compliance issues, ultimately enhancing governance and risk management. The business value of this DAG lies in its ability to streamline compliance processes, reduce the risk of non-compliance penalties, and improve overall data governance in life sciences.

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

Use cases

• Reduces risk of regulatory non-compliance penalties
• Enhances data governance and security protocols
• Improves operational efficiency in audit processes
• Facilitates better decision-making through actionable insights
• Strengthens stakeholder confidence in data integrity