@Article{M-10293,
AUTHOR = {Kawarkhe, Shyam},
TITLE = {MODERNIZING PHARMACEUTICAL VALIDATION: INTEGRATING CSA, AI, AND LIFECYCLE MANAGEMENT PRINCIPLES},
JOURNAL = {Scientific Research Journal of Medical and Health Science},
VOLUME = {3},
YEAR = {2025},
NUMBER = {1},
ARTICLE-NUMBER = {M-10293},
URL = {https://isrdo.org/journal/SRJMH/currentissue/modernizing-pharmaceutical-validation-integrating-csa-ai-and-lifecycle-management-principles},
ISSN = {2584-1521},
ABSTRACT = {This research paper explores the critical role of validation in the
pharmaceutical and life sciences industries, emphasising its importance in
ensuring product quality, patient safety, and regulatory compliance. It
outlines the various types of validation, including process, equipment,
cleaning, computer system, and analytical method validation, detailing their
objectives and documentation requirements. The study highlights regulatory
guidelines from global authorities such as the FDA, EMA, and WHO, underscoring
the necessity of thorough validation practices at every stage of drug
manufacturing and healthcare product development.The paper discusses Computer System Validation (CSV) and its growing
significance in the digital age, with a focus on data integrity, security, and
compliance with 21 CFR Part 11. It also examines risk management strategies and
Good Documentation Practices (GDP) as essential components for maintaining
robust validation frameworks.



Real-world industry case studies are referenced to illustrate the
practical applications and benefits of validation processes, demonstrating how
systematic validation reduces operational risks, improves product reliability,
and enhances regulatory preparedness. The paper concludes by emphasizing the
future importance of continuous process verification and the integration of
advanced technologies such as Artificial Intelligence (AI) and automation into
validation practices, to meet evolving regulatory expectations and industry
challenges.},
DOI = {}
}