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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

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.

About the authors

Vijaya Kumar
Vijaya Kumar is working with the Advanced Drug Development (ADD) platforms and CMC & Regulatory Operations team as a domain consultant with Chemistry, Manufacturing and Controls as core expertise.
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Vishal Mhatre
Vishal Mhatre is an associate vice president and a domain consultant working with the Regulatory Services group within TCS' Life Sciences unit. Vishal brings in over 27 years of industry experience, and in-depth expertise in regulatory project management, product strategy development, regulatory operations, and compliance.
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