CYBERSECURITY IN VALIDATION: PROTECTING SYSTEMS IN A DIGITALLY-CONNECTED WORLD
Keywords:
Pharmaceutical Validation, Cybersecurity Integration, Regulatory Compliance, Risk Assessment, Digital Transformation MetricsAbstract
This article explores the critical intersection of cybersecurity and system validation in the pharmaceutical industry, focusing on the evolving challenges and solutions in protecting digitally connected pharmaceutical systems. It examines the transformation of validation processes to incorporate cybersecurity measures, addressing regulatory compliance requirements, risk assessment protocols, and security control implementations. The discussion encompasses the integration of security considerations throughout the validation lifecycle, continuous monitoring strategies, and emerging technologies. Special attention is given to the implementation of advanced security frameworks, predictive maintenance approaches, and future considerations in maintaining secure pharmaceutical operations. The article provides insights into best practices for securing pharmaceutical systems while ensuring compliance with regulatory requirements and maintaining operational efficiency
References
Sanket J. Soni, "Digital transformation and industry 4.0 in pharma manufacturing: the role of iot, ai, and big data," Journal of Integral Sciences 2024. Available: https://www.researchgate.net/publication/385700323_Digital_transformation_and_industry_40_in_pharma_manufacturing_the_role_of_iot_ai_and_big_data
Pravin Ullagaddi, "A Framework for Cloud Validation in Pharma," Journal of Computer and Communications, 2024. Available:https://www.scirp.org/journal/paperinformation?paperid=136101
Joanna Edwards, "Strengthening Cybersecurity in the Pharmaceutical Industry," Pharma IQ Regulatory Analysis, 2024. Available: https://www.pharma-iq.com/regulatorylegal/interviews/strengthening-cybersecurity-in-the-pharmaceutical-industry
Black Duck Editorial Team, "Complex but helpful: Negotiating FDA guidance to build a cybersecurity program," Black Duck Security Journal, 2019. Available: https://www.blackduck.com/blog/fda-cybersecurity-guidance.html
Rawidh Alsaidalani, et al., "Quality Risk Management in Pharmaceutical Manufacturing Operations: Case Study for Sterile Product Filling and Final Product Handling Stage" MDPI Sustainability, 2022. Available: https://www.mdpi.com/2071-1050/14/15/9618
Joseph Boakai, "Data integrity considerations in pharma and life sciences," European Pharmaceutical Review, 2024. Available: https://www.europeanpharmaceuticalreview.com/article/219686/data-integrity-considerations-in-pharma-and-life-sciences/
Asheesh Singh, et al,. "Computer system validation in the perspective of the pharmaceutical industry," Research Gate Journal of Pharmaceutical Technology, 2018. Available: https://www.researchgate.net/publication/330428646_Computer_system_validation_in_the_perspective_of_the_pharmaceutical_industry
Krunal Parikh, et al., "VALIDATION AND SECURITY MEASURES FOR PHARMACEUTICAL DATA PROCESSING," Pharma Tutor Technical Review, 2012. Available: https://www.pharmatutor.org/articles/validation-security-measures-pharmaceutical-data-processing
Faten Farouk, et al., "Resolving Analytical Challenges in Pharmaceutical Process Monitoring Using Multivariate Analysis Methods: Applications in Process Understanding, Control, and Improvement," Spectroscopy Online, 2023. Available: https://www.spectroscopyonline.com/view/resolving-analytical-challenges-in-pharmaceutical-process-monitoring-using-multivariate-analysis-methods-applications-in-process-understanding-control-and-improvement
Ann Porten, "Predictive Maintenance in Pharmaceutical Manufacturing," Llumin Technical Review. Available: https://llumin.com/predictive-maintenance-in-pharmaceutical-manufacturing/
Sally Turner, "Cybersecurity in pharma: Securing the future" Pharmaceutical Technology, 2023. Available: https://www.pharmaceutical-technology.com/features/cybersecurity-in-pharma-securing-the-future/
N. Sarah Arden, et al., "Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future," International Journal of Pharmaceutics, 2021. Available: https://www.sciencedirect.com/science/article/pii/S0378517321003598