Abstract

PROCESS AUTOMATION IN PHARMA QUALITY ASSURANCE

J. B. Bachhav*, G. B. Sonawane, P. A. Gunjal, S. N. Aher

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Abstract

The role of automation in process industries has grown significantly in recent years. In the pharmaceutical sector, automation in quality assurance plays a crucial role in modern software development by enhancing efficiency, accuracy, and scalability. QA automation involves using automated tools and scripts to perform tests on software applications, covering various types of testing such as functional, regression, performance, and security testing across multiple platforms and environments. It reduces human errors through consistent execution, speeds up testing to align with rapid development cycles, and integrates seamlessly with CI/CD pipelines for continuous testing. Advanced systems leveraging AI and machine learning enable predictive analysis, although they require a substantial initial investment in tools and infrastructure, as well as skilled personnel to design and manage automated tests. When implemented effectively, QA automation shortens development time, lowers costs through early defect detection and reduced fix expenses, and improves overall quality. This evolution reflects the shift from traditional manual QA methods to the Industry 4.0 era, where technologies like robotics, AI, ML, and IoT set new benchmarks for precision, efficiency, and scalability.

Keywords: quality assurance, process automation, regulatory implications, AI, Process analytical technology (PAT).