Diseño Batch record electrónico en una planta de producción farmacéutica
Cargando...
Fecha
2023
Autores
Aragón Nigrin, Walter David
Soto Meza, Diego Raúl
Quintero González, Abelino
Páez Redondo, Cristian Enrique
Título de la revista
ISSN de la revista
Título del volumen
Editor
Ediciones Universidad Simón Bolívar
Facultad de Ingenierías
Facultad de Ingenierías
Resumen
SAP es uno de los principales productores mundiales de software para gestión de
procesos de negocio, y desarrolla soluciones que facilitan el procesamiento eficaz
de datos y el flujo de información entre las organizaciones.
SAP brinda múltiples funciones de negocio con una única visión de la verdad. Esto
ayuda a las empresas a gestionar mejor los procesos de negocio complejos
dándoles a los empleados de diferentes departamentos un acceso fácil a
información en tiempo real en toda la empresa. Como resultado, las empresas
pueden acelerar los flujos de trabajo, mejorar la eficiencia operativa, aumentar la
productividad, mejorar las experiencias de cliente, y en última instancia, aumentar
los beneficios.
Un Batch Record Electrónico (BRE) es una funcionalidad del módulo PP de SAP.
Se maneja a través de licencias de SAP y se permite el ingreso a las transacciones
implicadas por medio de Roles.
El proceso de diseño de un BRE la coordinación de procesos en SAP comprende la
configuración de las instrucciones de proceso en la receta de planificación, la
generación de recetas de control para las órdenes de proceso liberadas en la
manufactura de cápsulas blandas de gelatina, la entrega de las instrucciones de
proceso a los receptores y el diligenciamiento y cierre de las instrucciones.
La Herramienta de BRE ofrece la posibilidad de monitoreo constante y en tiempo
real del proceso de diligenciamiento y de los estados de las instrucciones de
producción a través del sistema SAP. Al finalizar es posible hacer uso de la opción
de impresión del Batch Record diligenciado durante el proceso de manera
electrónica y de la versión Máster Batch Record, cuando las personas autorizadas
para ello lo requieran.
El BRE automatiza y agiliza el proceso de documentación, lo que reduce la carga
de trabajo manual para los empleados encargados de generar y mantener los
registros. Al eliminar la necesidad de registrar y actualizar información en papel, se
liberan recursos y tiempo que pueden ser destinados a otras tareas de mayor valor
agregado, asi como en la mejora en la accesibilidad y disponibilidad de la
información. Con un BRE electrónico, los empleados pueden acceder a los registros
desde cualquier ubicación y en cualquier momento, lo que facilita la colaboración y
el intercambio de información entre diferentes departamentos. Esto promueve una
mayor eficiencia en la comunicación interna y agiliza los procesos de revisión y
aprobación
Además, el BRE proporciona una mayor precisión y consistencia en los registros,
minimizando la posibilidad de errores humanos. Esto no solo beneficia a los
empleados encargados de la generación del Batch Record, sino también a toda la
cadena de suministro y a los consumidores finales, ya que se garantiza una mayor
calidad y seguridad en los productos farmacéuticos.
La implementación de un Batch Record Electrónico no solo mejoraría la eficiencia
operativa y el cumplimiento normativo, sino que también tendría un impacto directo
en las personas involucradas en el proceso, Promoviendo su bienestar y
potenciando su capacidad para desempeñarse en su máximo nivel. Al final del día,
el objetivo es humanizar los procesos y crear un entorno laboral más gratificante
para todos los involucrados
SAP is one of the world's leading producers of business process management software, developing solutions that facilitate the efficient processing of data and the flow of information between organizations. SAP provides multiple business functions with a single view of the truth. This helps companies better manage complex business processes by giving employees in different departments easy access to real-time information across the company. As a result, businesses can speed up workflows, improve operational efficiency, increase productivity, improve customer experiences, and ultimately increase profits. An Electronic Batch Record (BRE) is a functionality of the SAP PP module. It is managed through SAP licenses and entry to the transactions involved is allowed through Roles. The design process of a BRE process coordination in SAP includes the configuration of process instructions in the planning recipe, the generation of control recipes for the process orders released in the manufacturing of soft gelatin capsules, the delivery of the process instructions to the recipients and the completion and closing of the instructions. The BRE Tool offers the possibility of constant and real-time monitoring of the fulfillment process and the status of production instructions through the SAP system. At the end, it is possible to use the option of printing the Batch Record completed electronically during the process and the Master Batch Record version, when the authorized persons require it. The BRE automates and streamlines the documentation process, reducing the manual workload for employees responsible for generating and maintaining records. By eliminating the need to record and update information on paper, resources and time are freed up that can be allocated to other tasks with greater added value, as well as improving the accessibility and availability of information. With an electronic BRE, employees can access records from any location and at any time, facilitating collaboration and information sharing between different departments. This promotes greater efficiency in internal communication and streamlines review and approval processes. Additionally, the BRE provides greater accuracy and consistency in records, minimizing the possibility of human error. This not only benefits the employees in charge of generating the Batch Record, but also the entire supply chain and end consumers, since greater quality and safety in pharmaceutical products is guaranteed. The implementation of an Electronic Batch Record would not only improve operational efficiency and regulatory compliance but would also have a direct impact on the people involved in the process, promoting their well-being and enhancing their ability to perform at their highest level. At the end of the day, the goal is to humanize processes and create a more rewarding work environment for everyone involved.
SAP is one of the world's leading producers of business process management software, developing solutions that facilitate the efficient processing of data and the flow of information between organizations. SAP provides multiple business functions with a single view of the truth. This helps companies better manage complex business processes by giving employees in different departments easy access to real-time information across the company. As a result, businesses can speed up workflows, improve operational efficiency, increase productivity, improve customer experiences, and ultimately increase profits. An Electronic Batch Record (BRE) is a functionality of the SAP PP module. It is managed through SAP licenses and entry to the transactions involved is allowed through Roles. The design process of a BRE process coordination in SAP includes the configuration of process instructions in the planning recipe, the generation of control recipes for the process orders released in the manufacturing of soft gelatin capsules, the delivery of the process instructions to the recipients and the completion and closing of the instructions. The BRE Tool offers the possibility of constant and real-time monitoring of the fulfillment process and the status of production instructions through the SAP system. At the end, it is possible to use the option of printing the Batch Record completed electronically during the process and the Master Batch Record version, when the authorized persons require it. The BRE automates and streamlines the documentation process, reducing the manual workload for employees responsible for generating and maintaining records. By eliminating the need to record and update information on paper, resources and time are freed up that can be allocated to other tasks with greater added value, as well as improving the accessibility and availability of information. With an electronic BRE, employees can access records from any location and at any time, facilitating collaboration and information sharing between different departments. This promotes greater efficiency in internal communication and streamlines review and approval processes. Additionally, the BRE provides greater accuracy and consistency in records, minimizing the possibility of human error. This not only benefits the employees in charge of generating the Batch Record, but also the entire supply chain and end consumers, since greater quality and safety in pharmaceutical products is guaranteed. The implementation of an Electronic Batch Record would not only improve operational efficiency and regulatory compliance but would also have a direct impact on the people involved in the process, promoting their well-being and enhancing their ability to perform at their highest level. At the end of the day, the goal is to humanize processes and create a more rewarding work environment for everyone involved.
Descripción
Palabras clave
SAP: Sistemas Aplicaciones y Productos, ERP: Planificador de recursos empresariales, BRE: Batch Record Electrónico, SAP: Systems Applications and Products, ERP: Enterprise Resource Planning, EBR: Electronic Batch Record
