Streamlining Change Control Processes in Regulatory Affairs: Best Practices and Case Studies

Sri Sai Subramanyam Challa; Abhip Dilip Chawda; Abhishek Pandurang Benke; Mitul Tilala

doi:10.55544/ijrah.4.4.12

Authors

Sri Sai Subramanyam Challa Independent Researcher, USA.
Abhip Dilip Chawda Independent Researcher, USA.
Abhishek Pandurang Benke Independent Researcher, USA.
Mitul Tilala Independent Researcher, USA.

DOI:

https://doi.org/10.55544/ijrah.4.4.12

Keywords:

change control, regulatory affairs, process optimization, quality management, compliance, case studies

Abstract

Change control is a critical component of regulatory affairs in various industries, particularly in pharmaceuticals, medical devices, and biotechnology. This research paper explores the challenges associated with traditional change control processes and presents best practices for streamlining these processes to improve efficiency, compliance, and overall product quality. Through a comprehensive literature review and analysis of case studies from leading organizations, we identify key strategies for optimizing change control workflows, leveraging technology, and fostering a culture of continuous improvement. The paper also examines the impact of streamlined change control processes on regulatory compliance, product lifecycle management, and organizational performance. Our findings suggest that implementing these best practices can lead to significant reductions in change implementation time, improved regulatory compliance, and enhanced product quality and safety.

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