Artificial Intelligence in Regulatory Compliance: Transforming Pharmaceutical and Healthcare Documentation
Abstract
Regulatory compliance and documentation are critical components in the pharmaceutical and healthcare industries, ensuring patient safety, ethical practices, and adherence to global standards. Traditional compliance processes often involve time-consuming manual tasks prone to inefficiencies and human error. With the increasing complexity of regulations, data volume, and innovation pace, Artificial Intelligence (AI) has emerged as a transformative tool to enhance regulatory operations. This paper explores the integration of AI technologies—such as Natural Language Processing (NLP), Machine Learning (ML), and Robotic Process Automation (RPA)—into compliance workflows. Applications include automated document analysis, real-time regulatory intelligence, streamlined clinical trial documentation, EHR auditing, and adverse event detection. These technologies offer notable benefits, including improved accuracy, operational efficiency, cost reduction, and faster regulatory submissions. However, the adoption of AI also raises challenges related to data privacy, regulatory acceptance, system integration, and workforce adaptation. Ensuring transparency and maintaining ethical standards are essential for the successful deployment of AI in these high-stakes environments. Overall, AI presents a promising solution to modernize compliance frameworks, provided that its implementation is guided by robust governance and collaboration between industry stakeholders and regulators.
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References
2. Rajkumar A, Dean J, Kohane I. Machine learning in medicine. N Engl J Med. 2019;380(14):1347–58.
3. Topol E. High-performance medicine: the convergence of human and artificial intelligence. Nat Med. 2019;25(1):44–56.
4. U.S. Food and Drug Administration. Artificial intelligence and machine learning (AI/ML)-based software as a medical device (SaMD) [Internet]. Silver Spring (MD): FDA; 2021 [cited 2025 May 18]. Available from: https://www.fda.gov/
5. IBM Watson Health. Artificial intelligence for smarter clinical trials [Internet]. Armonk (NY): IBM Corporation; 2021 [cited 2025 May 18]. Available from:
https://www.ibm.com/watson-health/
6. Kumar S, Singh M, Goyal N. Artificial intelligence applications in clinical trial documentation: A review. J Pharm Innov. 2023;18(2):245–53
7. ArisGlobal. LifeSphere Regulatory platform overview [Internet]. Waltham (MA): ArisGlobal; 2023 [cited 2025 May 18]. Available from: https://www.arisglobal.com/
8. Deloitte. Intelligent compliance: the AI-powered future of regulatory compliance [Internet]. New York (NY): Deloitte Insights; 2021 [cited 2025 May 18]. Available from:
https://www2.deloitte.com/
9. Aris Global. Bayer streamlines pharmacovigilance with LifeSphere Safety [Internet]. Waltham (MA): Aris Global; 2021 [cited 2025 May 18]. Available from:
https://arisglobal.com/customer-stories/bayer
10. Tiwari A, Gupta S. Impact of RPA and AI on documentation in healthcare industry. Health Inform J. 2020;26(4):2736–49.
11. Dwivedi YK, Hughes DL, Ismagilova E, Aarts G, Coombs C, Crick T, et al. Artificial intelligence (AI): Multidisciplinary perspectives on emerging challenges, opportunities, and agenda for research, practice and policy. Int J Inf Manage. 2021;57:101994.
12. McKinsey & Company. The role of AI in pharmacovigilance: improving adverse event detection [Internet]. New York (NY): McKinsey & Company; 2020 [cited 2025 May 18]. Available from:
https://www.mckinsey.com/
13. Ghosh S, Das R. AI in drug regulatory affairs: A strategic overview. Asian J Pharm Sci. 2022;17(4):567–74.
14. Lee D, Yoon SN. Application of artificial intelligence-based technologies in the healthcare industry: Opportunities and challenges. Int J Environ Res Public Health. 2021;18(1):271.
15. Singhal N, Sharma P. Challenges and opportunities of AI in pharmaceutical manufacturing. Pharma Times. 2021; 53(7):14–9.
16. Wang F, Casalino LP, Khullar D. Deep learning in medicine-promise, progress, and challenges. JAMA Intern Med. 2019;179(3):293–4.
17. World Health Organization. WHO guidance on the ethics and governance of artificial intelligence for health [Internet]. Geneva: WHO; 2021 [cited 2025 May 18]. Available from: https://www.who.int/
18. Veeva Systems Inc. Sumitomo Dainippon Pharma adopts Veeva Vault RIM to streamline global regulatory submissions [Internet]. Pleasanton (CA): Veeva Systems Inc.; 2019 Jul 24 [cited 2025 May 18]. Available from:
https://ir.veeva.com/investors/news-and-events/latest-news/press-release-details/2019/Sumitomo-Dainippon-Pharma-Adopts-Veeva-Vault-RIM-to-Streamline-Global-Regulatory-Submissions/default.aspx
19. MasterControl. Thermo Fisher Scientific empowers 30,000 users with integrated data and analytics [Internet]. Salt Lake City (UT): MasterControl; [cited 2025 May 18]. Available from:
https://www.mastercontrol.com/
20. MasterControl. Noveome Biotherapeutics advances novel biologic ST266 with MasterControl [Internet]. Salt Lake City (UT): MasterControl; [cited 2025 May 18]. Available from:
https://www.mastercontrol.com/
21. Pharma Tech Outlook. Aris Global LifeSphere improves data transparency and audit readiness [Internet]. New York (NY): Pharma Tech Outlook; 2021 [cited 2025 May 18]. Available from:
https://www.pharmatechoutlook.com/cxoinsights/aris-global-lifesphere-improves-data-transparency-nwid-733.html
22. European Commission. Ethics guidelines for trustworthy AI [Internet]. Brussels: High-Level Expert Group on AI; 2020 [cited 2025 May 18]. Available from:
https://digital-strategy.ec.europa.eu/
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