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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.

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Vijaya Kumar

Assistant general manager and senior domain consultant, Life sciences, TCS

Vishal Mhatre

Associate vice president and a senior domain consultant, Life sciences, TCS