Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices
Autor: | Oeystein Kjoersvik, Danielle Abatemarco, Robert C. Taylor, Ellen Mishalov, Pawel Dobracki, Eileen Leonard, Bhavin Patel, Elizabeth Savage, Kristof Huysentruyt, Mark Cherry |
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Rok vydání: | 2021 |
Předmět: |
Technology
Emerging technologies Leading Article Toxicology 030226 pharmacology & pharmacy Bridging (programming) Automation Pharmacovigilance 03 medical and health sciences 0302 clinical medicine Artificial Intelligence Humans Medicine Pharmacology (medical) 030212 general & internal medicine Implementation Risk management Pharmacology Risk Management business.industry Business operations Risk analysis (engineering) Resource use business |
Zdroj: | Drug Safety |
ISSN: | 1179-1942 0114-5916 |
Popis: | Pharmacovigilance is the science of monitoring the effects of medicinal products to identify and evaluate potential adverse reactions and provide necessary and timely risk mitigation measures. Intelligent automation technologies have a strong potential to automate routine work and to balance resource use across safety risk management and other pharmacovigilance activities. While emerging technologies such as artificial intelligence (AI) show great promise for improving pharmacovigilance with their capability to learn based on data inputs, existing validation guidelines should be augmented to verify intelligent automation systems. While the underlying validation requirements largely remain the same, additional activities tailored to intelligent automation are needed to document evidence that the system is fit for purpose. We propose three categories of intelligent automation systems, ranging from rule-based systems to dynamic AI-based systems, and each category needs a unique validation approach. We expand on the existing good automated manufacturing practices, which outline a risk-based approach to artificially intelligent static systems. Our framework provides pharmacovigilance professionals with the knowledge to lead technology implementations within their organizations with considerations given to the building, implementation, validation, and maintenance of assistive technology systems. Successful pharmacovigilance professionals will play an increasingly active role in bridging the gap between business operations and technical advancements to ensure inspection readiness and compliance with global regulatory authorities. |
Databáze: | OpenAIRE |
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