Browsing by Author "Gamboa Ojeda, Deisy"
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Item Implementación de las buenas prácticas de laboratorio en una empresa de dispositivos médicos basada en la Resolución 3619 del 2013(Universidad Santiago de Cali, 2019) Gamboa Ojeda, Deisy; Cachim Pérez, Paola Andrea; Garzón García, Guillermo (Director)This work was based on the requirements established in Resolution 3619 of 2013 of the Ministry of Health and Social Protection of Colombia, with the objective of implementing Good Laboratory Practices in an International Medical Devices company. An initial diagnosis was started by applying a checklist to assess laboratory compliance with respect to the requirements required by Resolution 3619 of 2013, finding that the Organization met 86% of the requirements of the standard. Using the PHVA cycle (Planning, Doing, Verifying and Acting) as a tool for continuous improvement, a work plan was prepared taking into account the results of the initial diagnosis to start working on meeting all the requirements; All laboratory personnel were also committed to participate in this process by providing training in the implementation of GLP. Through the progress of the implementation, documentary changes were generated to which their respective disclosure was made in order to guarantee the operation of the implementation; Finally, the technical and management requirements were evaluated through an internal audit, which allowed identifying and implementing an action plan in order to find opportunities for improvement in the laboratory. Finally, the certification of Good Laboratory Practices was obtained by INVIMA.