Development of a digital tool to address unregulated cases in various procedures for the registration public health interest products
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| Autores: | , , , |
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| Format: | artículo original |
| Status: | Versión publicada |
| Fecha de Publicación: | 2025 |
| Beskrivelse: | The results showed that all batches in the Regulatory Affairs Department of a pharmaceutical company must be constantly updated, as regulatory requirements are evolving globally. One of the tools available is Preventive Actions and Corrective Actions (CAPAs). Artificial intelligence (AI) is currently used to implement these systems. The objective of this research was to create a digital tool for the collection of historical information on cases not contemplated in the official regulation related to the submission of various procedures regarding over-the-counter medicines, cosmetics, medical devices, and food supplements in countries in Central America and the Caribbean, as well as Ecuador and Uruguay. To carry it out, a knowledge-based system (KBS) was developed employing CAPAs, with information not contemplated in the corresponding regulations. This work involved collecting historical information from the nations of interest, categorizing the list of preventions, separating the cases, reviewing the results, and unifying the information. The digital tool was then designed utilizing Microsoft SharePoint®, with the subsequent information migration. Finally, the final product was validated, and the work team was trained. Thanks to the work, an innovative and efficient user interface was designed without employing more traditional tools. Additionally, the validation of the knowledge base proved to be an appropriate digital strategy in terms of content, design, and format. |
| País: | Portal de Revistas TEC |
| Institution: | Instituto Tecnológico de Costa Rica |
| Repositorio: | Portal de Revistas TEC |
| Sprog: | Español |
| OAI Identifier: | oai:ojs.pkp.sfu.ca:article/7859 |
| Online adgang: | https://revistas.tec.ac.cr/index.php/tec_marcha/article/view/7859 |
| Palabra clave: | Industria farmacéutica Asuntos regulatorios Acción correctiva Acción preventiva Inteligencia artificial Sistema basado en el conocimiento Pharmaceutical industry regulatory affairs corrective action preventive action artificial intelligence knowledge-based system |