Transforming Pharma Regulatory Affairs in the Age of AI

To improve process efficiencies, regulatory chemistry manufacturing, controls, and operations teams need to assess the real need for automation.

Specific process automation requirements can be defined by:

• Mapping the entire end-to-end process.
  
• Identifying process steps that can be automated.
  
• Understanding the rationale for automation, maturity of process, business value, and availability of data.
  
  

For effective management of regulatory automation, organizations must consider the following:

• Intelligent operations: Push data-driven models through smart alerts and workflows.

• Technology simplification: Enables programs to make the technology landscape smarter, scalable, and future-ready.

• Data repositories: Improve data quality and accuracy by adopting standard approaches and allied technologies.

• AI and cognitive: Leveraging advanced technologies to convert information from structured and unstructured sources into knowledge and actionable insights.