Data Engineering for GxP Compliance

Authors

Ravi Kiran Koppichetti

Abstract

Data engineering plays a pivotal role in ensuring compliance with Good Practice (GxP) regulations, which are critical for maintaining the quality, safety, and efficacy of products in regulated industries such as pharmaceuticals, biotechnology, and healthcare. This paper explores the challenges, best practices, and technologies involved in designing and implementing GxP-compliant data engineering solutions. Key topics include data integrity, audit trails, data security, traceability, and validation, as well as the use of modern data platforms to meet regulatory requirements. Through a detailed case study, the paper illustrates the steps organizations can take to overcome challenges and achieve compliance. By adopting robust data engineering practices, organizations can ensure the integrity, security, and traceability of their data while meeting evolving regulatory expectations. This paper serves as a comprehensive guide for organizations seeking to navigate the complexities of data engineering in GxP environments.

Keywords

Data Engineering for GxP Compliance. Ravi Kiran Koppichetti. 2024. IJIRCT, Volume 10, Issue 5. Pages 1-10. https://www.ijirct.org/viewPaper.php?paperId=2503023