Integrating Cybersecurity in QMS: Safeguarding Compliance and Quality in Pharma and Biotech

Gottipati, Vamsi Krishna and Pujari, Sudha Rani (2025) Integrating Cybersecurity in QMS: Safeguarding Compliance and Quality in Pharma and Biotech. World Journal of Advanced Engineering Technology and Sciences, 15 (3). pp. 2455-2465. ISSN 2582-8266

The pharmaceutical and biotechnology industries are experiencing a paradigm shift as digital transformation intersects with stringent regulatory environments. With increasing reliance on automation, data systems, and connected infrastructures, the threat of cyberattacks has become a critical risk to quality management systems (QMS). This review article explores how cybersecurity can be integrated into QMS frameworks to safeguard regulatory compliance, ensure data integrity, and maintain product quality. A comprehensive analysis of regulatory requirements, industrial practices, experimental case studies, and theoretical models is presented. The article also identifies current challenges in implementation, evaluates technological tools such as AI and blockchain, and proposes future research directions. The findings highlight that cybersecurity, when embedded as a foundational layer in QMS, not only protects systems from threats but also enhances operational resilience and audit readiness. The paper concludes by emphasizing the necessity of cross-functional collaboration, updated regulatory frameworks, and adaptive technologies in building a cyber-resilient QMS for the future.