Evaluating challenges and solutions for ensuring regulatory compliance in cloud-hosted LIMS platforms used in pharmaceutical and biotech industries

Lalitha Amarapalli (), Vincent Kanka () and Gnanendra Reddy Muthirevula ()

Journal of AI-Powered Medical Innovations (International online ISSN 3078-1930), 2024, vol. 2, issue 1, 153-167

Abstract: The adoption of cloud-hosted Laboratory Information Management Systems (LIMS) in the pharmaceutical and biotech industries offers transformative benefits, including scalability, cost efficiency, and remote collaboration. However, ensuring regulatory compliance in these environments—particularly with standards such as 21 CFR Part 11, GDPR, and GxP—presents significant challenges. This study evaluates the key obstacles faced by organizations leveraging cloud-based LIMS, including data integrity risks, audit trail reliability, electronic signature non-repudiation, and vendor accountability in shared infrastructure models. Through a mixed-methods approach combining literature analysis, case studies, and interviews with industry experts, the research identifies actionable solutions to these challenges. Findings highlight the critical role of robust encryption, immutable audit logs, risk-based validation frameworks, and real-time compliance monitoring tools. The study also underscores the importance of vendor partnerships, staff training, and agile governance models to align cloud agility with regulatory rigor. Results demonstrate that while multi-tenancy risks and jurisdictional ambiguities persist, a hybrid approach combining technical safeguards and organizational protocols can achieve compliance without compromising innovation. This work provides a roadmap for pharmaceutical and biotech firms to navigate the evolving regulatory landscape while harnessing the full potential of cloud-hosted LIMS.

Keywords: Regulatory compliance; Cloud-hosted LIMS; 21 CFR Part 11; Pharmaceutical industry; Biotechnology (search for similar items in EconPapers)
Date: 2024
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