| {"docstore/data": {"1527b74a-58f0-45d9-a30f-8aae2d533c72": {"__data__": {"id_": "1527b74a-58f0-45d9-a30f-8aae2d533c72", "embedding": null, "metadata": {"page_label": "1", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Validation and Change Control of Computerized Systems", "questions_this_excerpt_can_answer": "1. What are the specific stages included in the computerized system validation process according to the \"GU\u00cdA BPM ARCSA 2020\" document?\n2. Does the \"GU\u00cdA BPM ARCSA 2020\" outline requirements for periodic evaluation after the initial validation of computerized systems, and if so, what does this evaluation entail?\n3. How does the \"GU\u00cdA BPM ARCSA 2020\" document address the considerations for environmental factors such as location, power source, temperature, and magnetic disturbances in the use of computerized systems?", "excerpt_keywords": "Computerized system validation, Change control, Environmental factors, Periodic evaluation, Data integrity"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "e9a03e57-245a-484b-a7b7-0e2864663485", "node_type": "4", "metadata": {"page_label": "1", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "61c1996e0050780ecb9f53ddf1ee0f13f39fc74c452d0260def189dd906ad1e9", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "dd4f2265-8028-4ec4-ae6f-2813d6c00d65", "node_type": "1", "metadata": {}, "hash": "bcb9f34eff063c3259f16ea82f94cc0fcac37dcd7cded1ddb1db25d0d156e418", "class_name": "RelatedNodeInfo"}}, "text": "|requerimiento|si|no|na|\n|---|---|---|---|\n|?los sistemas computarizados son validados en el nivel apropiado para su uso y aplicacion?| | | |\n|?el sistema computarizado incluye las siguientes etapas: planificacion, especificacion, programacion, verificacion, commissioning, documentacion de operacion, monitoreo y modificacion?|x| | |\n|el proposito de la validacion de un sistema computarizado es garantizar un grado aceptable de evidencia (documentada, datos originales), confianza (cumplimiento riguroso, fiable y exhaustivo de las especificaciones predeterminadas), uso previsto, precision, consistencia y fiabilidad.| | | |\n|?se encuentran validadas las especificaciones del sistema como las especificaciones funcionales?|x| | |\n|?se realiza la evaluacion periodica (o continua) despues de la validacion inicial?|x| | |\n|?existen procedimientos escritos para monitorear el desempeno, control de cambios, seguridad del programa y de los datos, calibracion y mantenimiento, capacitacion de personal, recuperacion en situaciones de emergencia y reevaluacion periodica?|x| | |\n|los aspectos de las operaciones computarizadas consideran durante la validacion lo siguiente:|x| | |\n|redes|x| | |\n|manual de copias de seguridad (manual back-ups)|x| | |\n|controles entrada/salida|x| | |\n|documentacion del proceso|x| | |\n|monitoreo|x| | |\n|alarmas|x| | |\n|recuperacion en situaciones de cortes energeticos|x| | |\n\n|requerimiento|si|no|na|\n|---|---|---|---|\n|?existe un documento de control o especificacion del sistema?|x| | |\n|?el documento de control indica los objetivos del sistema informatico propuesto, los datos que deben registrarse y almacenarse, el flujo de ellos y como interactuan con otros sistemas y procedimientos, la informacion a ser producida, los limites de cualquier variable y el programa operativo y el programa de prueba (incluye ejemplos de cada documento producido por el programa)?| | | |\n|?los elementos del sistema considerados en la validacion incluyen: hardware (equipos), software (procedimientos) y personas (usuarios)?|x| | |\n\n|requerimiento|si|no|na|\n|---|---|---|---|\n|una especificacion del funcionamiento o del desempeno debe proporcionar instrucciones para verificar, operar y mantener el sistema, asi como tambien los nombres de la(s) persona(s) responsable(s) de su desarrollo y funcionamiento.|x| | |\n|?se consideran los siguientes aspectos generales ubicacion, fuente de poder, temperatura, y perturbaciones magneticas cuando se utilizan sistemas computarizados?|x| | |\n|?los sistemas computacionales son verificados y revalidados?|x| | |\n|?los sistemas computacionales tienen control de cambios, conforme el procedimiento definido; que incluya disposiciones para el chequeo, la aprobacion y la implementacion del cambio?|x| | |\n|?los datos son revisados periodicamente para confirmar que estos han sido transferidos con exactitud y confiabilidad?| | | |\n\n|requerimiento|si|no|na|\n|---|---|---|---|\n|?los datos son ingresados o corregidos unicamente por personas autorizadas para hacerlo?|x| | |", "start_char_idx": 0, "end_char_idx": 3032, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "dd4f2265-8028-4ec4-ae6f-2813d6c00d65": {"__data__": {"id_": "dd4f2265-8028-4ec4-ae6f-2813d6c00d65", "embedding": null, "metadata": {"page_label": "2", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Seguridad y validaci\u00f3n de sistemas computarizados para la manipulaci\u00f3n de datos autorizados.", "questions_this_excerpt_can_answer": "1. What specific security measures are outlined in the \"GU\u00cdA BPM ARCSA 2020\" for preventing unauthorized data access or manipulation in computerized systems used for handling authorized data within the pharmaceutical industry in Ecuador?\n\n2. How does the \"GU\u00cdA BPM ARCSA 2020\" document address the validation and verification process for critical data entry into computer systems by authorized personnel, including the requirement for independent verification and release for use by a second authorized person?\n\n3. What are the requirements and procedures detailed in the \"GU\u00cdA BPM ARCSA 2020\" for creating, maintaining, and storing backup copies of all files and data to prevent intentional or accidental damage, as part of ensuring data integrity and security in computerized systems within the pharmaceutical sector?", "prev_section_summary": "The section discusses the validation and change control of computerized systems according to the \"GU\u00cdA BPM ARCSA 2020\" document. Key topics include the stages of the validation process, requirements for periodic evaluation after initial validation, considerations for environmental factors, specifications of the system, monitoring performance, control of changes, and data integrity. Entities mentioned include hardware, software, users, system specifications, and data validation processes.", "excerpt_keywords": "Seguridad, validaci\u00f3n, sistemas computarizados, manipulaci\u00f3n de datos, procedimientos operativos est\u00e1ndar"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "a92f65ac-54e1-4bd9-94bb-340b16053a97", "node_type": "4", "metadata": {"page_label": "2", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "3765e06df0c087bbc6e6690fa0edad3ba9ca4a6ae6b831bf81db0f114972a484", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "1527b74a-58f0-45d9-a30f-8aae2d533c72", "node_type": "1", "metadata": {"page_label": "1", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "61c1996e0050780ecb9f53ddf1ee0f13f39fc74c452d0260def189dd906ad1e9", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "6d47894f-e752-422b-811f-734b30aeda01", "node_type": "1", "metadata": {}, "hash": "6c7bcd6b06de0d834dbeef4617bb6ceacbad47b98fb0d4dd3a01a80a7b8308c4", "class_name": "RelatedNodeInfo"}}, "text": "## 68.2 ?los sistemas de seguridad se encuentran correctamente instalados para impedir el ingreso o la manipulacion de datos no autorizados?\n\nx\n\n## 68.3 ?todas las actividades de ingreso de datos, cambio o correcciones de las entradas incorrectas y la creacion de copias de seguridad son llevadas a cabo en conformidad a los procedimientos operativos estandar (pos) escritos y aprobados?\n\nx\n\n|requerimiento|seguridad|si|no|na|\n|---|---|---|---|---|\n|68.4 ?los procedimientos de seguridad se encuentran por escrito?| | |x| |\n|68.5 ?la seguridad tambien se extiende a los dispositivos usados para almacenar programas, tales como cintas, discos y tarjetas magneticas?| | |x| |\n|68.6 ?el acceso a estos dispositivos es controlado?| | |x| |\n|68.7 ?la trazabilidad aplicada es capaz de identificar las personas que ingresaron datos o hicieron cambios, liberaron materiales, o realizaron otros pasos criticos en la fabricacion o en control?| | |x| |\n|68.8 ?el ingreso de datos criticos a un computador por una persona autorizada (por ejemplo, el ingreso de una formula maestra de produccion) es verificada de forma independiente y liberada para uso por una segunda persona autorizada?| | |x| |\n|68.9 ?se validan los poss para determinados sistemas o procesos, ejemplo, deben definirse y probarse los procedimientos a seguir en caso de que el sistema falle o se averie?| | | |ox|\n|68.10 ajustes alternativos deben ser realizados por el equipo de validacion, y se debe disponer de un procedimiento de recuperacion en situaciones de desastre para los sistemas que necesitan funcionar en caso de averias| | |x| |\n\n## 69 copias de seguridad (back-ups)\n\n|requerimiento|si|no|na|\n|---|---|---|---|\n|69.1 ?se crean copias de seguridad de todos los archivos y datos regularmente, las se mantienen y almacenan en un lugar seguro, para prevenir danos intencionales o accidentales?| |x| |\n\n## 70 requerimiento validacion\n\n|70.1 la planificacion es una etapa del proceso de validacion, la cual debe considerar la politica de validacion, el programa del proyecto y los poss.|x|\n|---|---|\n|70.2 se deben definir los sistemas anexos a los sistemas computarizados y a los proveedores, y tanto estos como el producto deben ser evaluados. el sistema debe ser disenado y construido, teniendo en consideracion los tipos, pruebas y garantia de calidad del software.|x|\n|70.3 despues de la instalacion del sistema, este debe ser calificado. la extension de la calificacion debe depender de la complejidad del sistema.", "start_char_idx": 0, "end_char_idx": 2487, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "6d47894f-e752-422b-811f-734b30aeda01": {"__data__": {"id_": "6d47894f-e752-422b-811f-734b30aeda01", "embedding": null, "metadata": {"page_label": "2", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Seguridad y validaci\u00f3n de sistemas computarizados para la manipulaci\u00f3n de datos autorizados.", "questions_this_excerpt_can_answer": "1. What specific components and aspects of a computerized system are required to be validated according to the 2020 ARCSA BPM Guide for software in the pharmaceutical industry in Ecuador?\n \n2. How does the 2020 ARCSA BPM Guide address the validation of hardware and software in terms of input and output devices, signal converters, and the central processing unit (CPU) for computerized systems used in pharmaceutical data handling?\n\n3. What are the detailed requirements for the validation of computerized system environments, including the location and environmental considerations, as outlined in the 2020 ARCSA BPM Guide for ensuring data integrity and security in pharmaceutical operations?", "prev_section_summary": "The section discusses the security and validation measures outlined in the \"GU\u00cdA BPM ARCSA 2020\" for computerized systems handling authorized data in the pharmaceutical industry in Ecuador. Key topics include security measures to prevent unauthorized data access, validation processes for critical data entry, creation and storage of backup copies of files and data, written security procedures, control of access to storage devices, traceability of data entry and critical steps, independent verification of data entry, validation of procedures for system failures, and disaster recovery procedures. The section also addresses the importance of regular backups, validation planning, evaluation of systems and suppliers, system qualification after installation, and consideration of software quality assurance in system design and construction.", "excerpt_keywords": "Keywords: ARCSA, BPM, software, validation, computerized systems"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "a92f65ac-54e1-4bd9-94bb-340b16053a97", "node_type": "4", "metadata": {"page_label": "2", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "3765e06df0c087bbc6e6690fa0edad3ba9ca4a6ae6b831bf81db0f114972a484", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "dd4f2265-8028-4ec4-ae6f-2813d6c00d65", "node_type": "1", "metadata": {"page_label": "2", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "fe775e62fb77e3d86e5d0fe83bfbb35c09a048f222067d78fa766936d646730f", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "64ee46b7-7679-454a-8140-766579dea8a1", "node_type": "1", "metadata": {}, "hash": "dca4f3517a99015733f5f04f59e2531e94b64c30ffef2a3b85f506bf0a84d08a", "class_name": "RelatedNodeInfo"}}, "text": "el sistema debe ser evaluado y realizar la calificacion de desempeno, control de cambios, mantenimiento y calibracion, la seguridad, planificacion de contingencia, poss, capacitacion, monitoreo del desempeno, y reevaluacion periodica.|x|\n\n## 71 validacion de hardware y software\n\n|requerimiento|si|no|na|\n|---|---|---|---|\n|71.1 se encuentran validados los siguientes aspectos del sistema computarizado:| |x| |\n|tipos| |x| |\n|dispositivo de entrada| |x| |\n|dispositivo de salida| |x| |\n|convertidor de senales| |x| |\n|71.1.1 unidad de procesamiento central (cpu)| |x| |\n|sistema de distribucion| |x| |\n|dispositivos perifericos| |x| |\n|aspectos claves| |x| |\n|ubicacion: entorno distancia dispositivo de entrada| |x| |\n|senales de conversion| |x| |\n|71.1.2 operacion de entrada / salida (i/o)| |x| |", "start_char_idx": 2488, "end_char_idx": 3287, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "64ee46b7-7679-454a-8140-766579dea8a1": {"__data__": {"id_": "64ee46b7-7679-454a-8140-766579dea8a1", "embedding": null, "metadata": {"page_label": "3", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Validation and Calibration of Hardware and Software in Command Overrides: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific criteria are outlined in the \"GU\u00cdA BPM ARCSA 2020\" for validating and calibrating hardware in terms of its operational limits and performance under worst-case scenarios?\n \n2. How does the \"GU\u00cdA BPM ARCSA 2020\" document address the responsibility of maintaining hardware validation data when the validation is performed by an external company, such as a computer supplier?\n\n3. According to the \"GU\u00cdA BPM ARCSA 2020\" guide, what are the key aspects of software validation, including the validation of the software's language and level, as outlined in the context provided?", "prev_section_summary": "The section discusses the validation requirements for hardware and software in computerized systems according to the 2020 ARCSA BPM Guide for the pharmaceutical industry in Ecuador. It outlines the specific components that need to be validated, such as input and output devices, signal converters, the central processing unit (CPU), system distribution, peripheral devices, and key aspects related to location, environmental considerations, and signal conversion. The excerpt emphasizes the importance of evaluating and qualifying system performance, change control, maintenance, calibration, security, contingency planning, training, performance monitoring, and periodic reevaluation for ensuring data integrity and security in pharmaceutical operations.", "excerpt_keywords": "Validation, Calibration, Hardware, Software, ARCSA BPM Guide"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "e9556713-0f31-4fa1-8f89-4a7bd72bc71b", "node_type": "4", "metadata": {"page_label": "3", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "2791f4b87e3cd0c2c9bda045b89801de7437973b9cb7041bb28f892530683043", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "6d47894f-e752-422b-811f-734b30aeda01", "node_type": "1", "metadata": {"page_label": "2", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "7c6ec88ef56d7f959e00434f843826ab733bbe328d284b88931b58e080b0e892", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "d9a34d84-f18d-4d11-a733-2c0e17d86337", "node_type": "1", "metadata": {}, "hash": "e62ec92429eb4a6f3a2cd45ec4eacf284ebe5f6a462e9ac0592255cff289d474", "class_name": "RelatedNodeInfo"}}, "text": "## comando de sobreescritura (command overrides)\n\n|mantenimiento|x|\n|---|---|\n|validacion|x|\n|funcion|x|\n|limites|x|\n|peor caso|x|\n\n## reproducibilidad/consistencia\n\ndocumentacion\nx\n\n## revalidacion\n\nvalidacion de hardware y software\n\n|requerimiento|si|no|na|\n|---|---|---|---|\n|?se realizan pruebas y desafios apropiados, como parte del proceso de validacion al hardware?| | | |\n|?la atencion del hardware se centra en su ubicacion, mantenimiento y calibracion, asi como su validacion/calificacion? (pueden influir en el sistema la estatica, el polvo, las fluctuaciones de voltaje de la fuente de poder y las interferencias electromagneticas. la extension de la validacion dependera de la complejidad del sistema).| | | |\n\n## la validacion/calificacion del hardware demuestra:\n\n|que la capacidad del hardware este acorde con su funcion asignada (por ejemplo, idioma extranjero)|x|\n|---|---|\n|que opera dentro de los limites operacionales (por ejemplo, memoria, puertos de conexion, puertos de entrada)|x|\n|que se desempena aceptablemente bajo las condiciones del peor caso, (por ejemplo, largas horas, temperaturas extremas)|x|\n|reproducibilidad / consistencia (por ejemplo, desempenando al menos 3 ejecuciones bajo diferentes condiciones)|x|\n|?la validacion se realiza en conformidad a protocolos escritos de calificacion, y los resultados se registran en los informes de calificacion?|x|\n|?se realiza una revalidacion cuando se realizan cambios significativos?|x|\n|gran parte de la validacion de hardware puede ser realizada por el proveedor del computador. sin embargo, la responsabilidad final por la idoneidad del equipo usado continua siendo de la compania|x|\n|?la compania mantiene los datos de validacion de hardware y sus protocolos? (cuando la informacion de la validacion es generada por una empresa externa, por ejemplo, el proveedor del computador, la compania no requiere mantener todos los registros de los numerosos resultados de las pruebas; sin embargo, tales registros deben ser lo suficientemente completos (incluyendo los resultados generales y protocolos) para permitir a la compania evaluar la conformidad de la validacion. sera inadecuado, por ejemplo, una mera certificacion de idoneidad del proveedor).|x|\n\n## software\n\n|se encuentran validados los siguientes aspectos del sistema computarizado:|x|\n|---|---|\n|nivel|x|\n|lenguaje del equipo|x|\n\n## lenguaje del ensamblaje\n\n|lenguaje del nivel avanzado|x|\n|---|---|\n|lenguaje de aplicacion|x|\n|identificacion del software|x|\n|lenguaje|x|\n|nombre|x|\n|funcion|x|\n|entrada|x|\n\n## salida\n\n|punto de control fijo (fixed set point)|x|\n|---|---|\n|punto de control variable (variable set point)|x|", "start_char_idx": 0, "end_char_idx": 2664, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "d9a34d84-f18d-4d11-a733-2c0e17d86337": {"__data__": {"id_": "d9a34d84-f18d-4d11-a733-2c0e17d86337", "embedding": null, "metadata": {"page_label": "4", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Validaci\u00f3n y Calificaci\u00f3n de Sistemas y Equipos en Desarrollo de Software: Proceso y Metodolog\u00edas.", "questions_this_excerpt_can_answer": "1. What specific criteria are outlined in the \"GU\u00cdA BPM ARCSA 2020\" for identifying key aspects of computer programs used in pharmaceutical manufacturing, including their language, function, and input/output processes?\n\n2. How does the \"GU\u00cdA BPM ARCSA 2020\" define the process and methodologies for validating software to ensure it performs consistently within pre-established limits, especially those controlling manufacturing and processes in the pharmaceutical industry?\n\n3. According to the \"GU\u00cdA BPM ARCSA 2020,\" what are the requirements for the qualification of systems and equipment in a laboratory setting to ensure they are appropriately designed, located, installed, operated, and maintained for their intended purpose?", "prev_section_summary": "The section discusses the validation and calibration of hardware and software in command overrides, as outlined in the \"GU\u00cdA BPM ARCSA 2020\" document. Key topics include the validation criteria for hardware, such as operational limits, performance under worst-case scenarios, reproducibility/consistency, and revalidation. The responsibility of maintaining hardware validation data when performed by an external company is also addressed. Additionally, the key aspects of software validation, including the validation of software language and level, are outlined. The section emphasizes the importance of ensuring hardware operates within its assigned function, operational limits, and under worst-case conditions, as well as the validation of software aspects like level and language.", "excerpt_keywords": "software validation, equipment qualification, pharmaceutical manufacturing, system design, document control"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "dddfde13-1961-4715-b982-19a9e0560a19", "node_type": "4", "metadata": {"page_label": "4", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "a36fb5db0874a29c1e24c42675bc5bd9cf25abcad527003884f6206c8c3f32ad", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "64ee46b7-7679-454a-8140-766579dea8a1", "node_type": "1", "metadata": {"page_label": "3", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "2791f4b87e3cd0c2c9bda045b89801de7437973b9cb7041bb28f892530683043", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "f724c83d-1d00-4bb4-9763-3d6f1b0412e3", "node_type": "1", "metadata": {}, "hash": "71de4639ac182dcbed024e521b86b62a3fa93ac8361505864b8c810153ff4726", "class_name": "RelatedNodeInfo"}}, "text": "## ediciones (edits)\n\nx\n\n## manipulacion de entrada\n\nx\n\n## programa de sobreescritura (program overrides)\n\nx\n\n## aspectos claves\n\nx\n\n## 71.9.3 desarrollo de software\n\nx\n\n## seguridad del software\n\nx\n\n## validacion\n\nx\n\n## funcion\n\nx\n\n## 71.9.4 peor caso\n\nx\n\n## repeticiones\n\nx\n\n## documentacion\n\nx\n\n## revalidacion\n\nx\n\n## ?se encuentra incluido el software en un menu? (software es el termino empleado para describir el conjunto completo de programas utilizados por un computador)\n\nx\n\n## los registros se consideran un software ?se encuentran focalizados en la exactitud, seguridad, acceso, conservacion de registros, revision, doble chequeo, documentacion y exactitud de la reproduccion?\n\nx\n\n## identificacion\n\n?la compania identifica los siguientes puntos claves de los programas computacionales: lenguaje, nombre, funcion (objetivo del programa), entrada (determinar entradas), salida (determinar salidas), punto de control fijo (variables del proceso que no pueden ser cambiadas por el operador), punto de control variable (ingresados por el operador), ediciones (rechazar entrada/salida que no se ajuste a los limites y minimizar errores, por ejemplo, ingreso de numeros de cuatro o cinco caracteres), manipulacion de entrada (y ecuaciones) y programa de sobre escritura (por ejemplo, detener un mezclador antes de tiempo)?\n\nx\n\n## se debe identificar el personal que tiene la capacidad y/o esta autorizado a escribir, alterar o acceder a los programas.\n\nx\n\n## ?la validacion del software garantiza que los programas computacionales (especialmente aquellos que controlan la fabricacion y los procesos) se desempenaran consistentemente como se espera, dentro de los limites pre-establecidos?\n\nx\n\n## durante la planificacion de la validacion, se consideran los siguientes puntos:\n\nfuncion: ?el programa coincide con la funcion operativa asignada (por ejemplo, genera la documentacion del lote, los diferentes lotes de materiales utilizados en un lote determinado)\n\npeor caso: realizar la validacion bajo diferentes condiciones (por ejemplo, velocidad, volumen de datos, frecuencia)\n\nrepeticiones: suficiente numero de veces (repetir ingresos de datos)\n\ndocumentacion: protocolos e informes\n\nrevalidacion: necesaria ?cuando se realizan cambios significativos\n\n## 72 calificacion de sistemas y equipos\n\n|requerimiento|si|no|na|\n|---|---|---|---|\n|?los sistemas y equipos se encuentran apropiadamente disenados, ubicados, instalados, operados y mantenidos para ajustarse a su proposito previsto?| |x| |\n|?se encuentran calificados los sistemas criticos, es decir, aquellos cuyo desempeno consistente puede tener un impacto en la calidad de los productos?| |x| |\n|?los equipos criticos se encuentran calificados? (el continuo desempeno adecuado de los equipos es importante para asegurar consistencia lote a lote. por lo tanto, los equipos criticos deben ser calificados)| |x| |\n|?cuenta el laboratorio con una politica de calificacion para sistemas y equipos?| |x| |", "start_char_idx": 0, "end_char_idx": 2964, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "f724c83d-1d00-4bb4-9763-3d6f1b0412e3": {"__data__": {"id_": "f724c83d-1d00-4bb4-9763-3d6f1b0412e3", "embedding": null, "metadata": {"page_label": "5", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "\"Assessment of Systems and Equipment in Production and Quality Control\"", "questions_this_excerpt_can_answer": "1. What specific stages of qualification are mentioned for new systems and equipment before they are used in production and quality control according to the 2020 ARCSA BPM Guide?\n \n2. How does the 2020 ARCSA BPM Guide address the need for periodic requalification and requalification after changes for systems and equipment used in production and quality control environments?\n\n3. According to the 2020 ARCSA BPM Guide, are there any specific annexes that provide guidelines on the qualification of water purification systems and heating, ventilation, and air conditioning (HVAC) systems?", "prev_section_summary": "The section discusses the validation and qualification of systems and equipment in software development, specifically focusing on pharmaceutical manufacturing. Key topics include identifying key aspects of computer programs, validation processes, software security, program overrides, documentation requirements, and the qualification of critical systems and equipment in a laboratory setting. The section emphasizes the importance of ensuring software consistency within pre-established limits and the appropriate design, installation, operation, and maintenance of equipment for their intended purpose. Key entities mentioned include software programs, input/output processes, validation criteria, personnel authorized to access programs, and the need for protocols and reports during validation processes.", "excerpt_keywords": "Qualification, Systems, Equipment, Production, Quality Control"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "c4125bdf-12a6-4e00-bf1e-870259fffc4d", "node_type": "4", "metadata": {"page_label": "5", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "b25c371956866c10cbe3fc6bf0a7f89ad9d4c22af9a6cf0404f751dac76f4e7d", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "d9a34d84-f18d-4d11-a733-2c0e17d86337", "node_type": "1", "metadata": {"page_label": "4", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "a36fb5db0874a29c1e24c42675bc5bd9cf25abcad527003884f6206c8c3f32ad", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "eac0e653-1ea8-40f9-bb4c-aad5c47c0834", "node_type": "1", "metadata": {}, "hash": "45ff6b15b66cafc5f842f9bca7889774f06a2481bfba26783f8c3032b9680895", "class_name": "RelatedNodeInfo"}}, "text": "## 72.5\n\n?la politica y el programa de calificacion incorpora los equipos (incluyendo instrumentos) utilizados en la produccion y en el control de calidad?\n\n## 72.6\n\n?los sistemas y equipos nuevos son sometidos a todas las etapas de calificacion, incluyendo calificacion de diseno (dq), calificacion de instalacion (iq), calificacion de operacion (oq) y calificacion de desempeno (pq), segun corresponda?\n\n## 72.7\n\nen algunos casos, pueden no ser requeridas todas las etapas de calificacion. ver ademas las directrices en calificacion de sistemas de purificacion de agua en anexo 2 y de calefaccion, ventilacion y aire acondicionado (hvac) en anexo 1.\n\n## 72.8\n\n?se encuentran los sistemas calificados antes que los equipos?\n\n## 72.9\n\n?los equipos se encuentran calificados previo al uso rutinario para proveer evidencia documentada de que el equipo se ajusta al proposito previsto?\n\n## 72.10\n\n?los sistemas y equipos son sometidos a recalificaciones periodicas, asi como tambien a recalificaciones despues de cambios?\n\n## 72.11\n\n?se encuentran ciertas etapas de la calificacion de los equipos realizadas por el proveedor o por terceros?\n\n?se encuentra disponible la documentacion relevante asociada con la calificacion, incluyendo procedimientos de operacion estandar (poss), especificaciones y criterios de aceptacion, certificados y manuales?\n\n## 72.12\n\n?la calificacion se realiza de acuerdo a protocolos de calificacion predeterminados y aprobados?\n\n## 72.13\n\n?los resultados de la calificacion son registrados y plasmados en informes de calificacion?\n\n|requerimiento|si|no|na|\n|---|---|---|---|\n|?la extension de la calificacion se encuentra basada en la criticidad de un sistema o equipo (ej. mezcladores, autoclaves o sistemas computacionales)?|x| | |\n\n## 73\n\ncalificacion de diseno\n\n|requerimiento|si|no|na|\n|---|---|---|---|\n|?son considerados los requerimientos del usuario al decidir el diseno especifico de un sistema o equipo?|x| | |\n|?se selecciona un proveedor adecuado para el sistema o equipo correspondiente (proveedor aprobado)?|x| | |\n\n## 74\n\ncalificacion de instalacion\n\n|requerimiento|si|no|na|\n|---|---|---|---|\n|?se encuentran instalados correctamente los sistemas y equipos, de acuerdo a un plan de instalacion y a un protocolo de calificacion de instalacion?|x| | |\n|?se establecen los requisitos para la calibracion, mantenimiento y limpieza, durante la instalacion?|x| | |\n|?se incluye en la calificacion de instalacion, la identificacion y verificacion de todos los elementos del sistema, piezas, servicios, controles, medidores y otros componentes?|x| | |\n|?son calibrados contra estandares nacionales o internacionales adecuados, que sean trazables, los dispositivos de medicion, de control e indicadores?|x| | |\n|?existen registros documentados para la instalacion (informe de calificacion de instalacion) para indicar la conformidad de la instalacion?|x| | |\n|?incluyen los registros documentados los detalles del proveedor y fabricante, nombre del sistema o equipo, modelo y numero de serie, fecha de la instalacion, repuestos, procedimientos relevantes y certificados?|x| | |\n\n## 75\n\ncalificacion de operacion\n\n|requerimiento|si|no|na|\n|---|---|---|---|\n|?se verifica la operacion de los sistemas y equipos de acuerdo con un protocolo de calificacion de operacion?|x| | |", "start_char_idx": 0, "end_char_idx": 3307, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "eac0e653-1ea8-40f9-bb4c-aad5c47c0834": {"__data__": {"id_": "eac0e653-1ea8-40f9-bb4c-aad5c47c0834", "embedding": null, "metadata": {"page_label": "6", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Recalificaci\u00f3n y Verificaci\u00f3n de Sistemas y Equipos en Uso: Proceso y Procedimientos.", "questions_this_excerpt_can_answer": "1. How does the 2020 ARCSA BPM Guide address the requirement for recalification of systems and equipment in use, specifically in terms of a defined program and the factors considered for determining recalification frequency?\n \n2. What criteria does the 2020 ARCSA BPM Guide specify for justifying the extension of recalification after changes to systems and equipment, including the role of risk evaluation in this process?\n\n3. According to the 2020 ARCSA BPM Guide, what documentation and data are required to support and verify the proper operation and performance of systems and equipment that have been in use over time without undergoing installation and/or operation qualification?", "prev_section_summary": "This section discusses the assessment of systems and equipment in production and quality control according to the 2020 ARCSA BPM Guide. It covers topics such as the stages of qualification for new systems and equipment, the need for periodic requalification and requalification after changes, specific annexes providing guidelines for water purification systems and HVAC systems, and the requirements for design qualification, installation qualification, and operational qualification. The section emphasizes the importance of following predetermined and approved qualification protocols, documenting the results of qualification, and ensuring the proper installation, calibration, and maintenance of systems and equipment.", "excerpt_keywords": "Recalificaci\u00f3n, sistemas, equipos, ARCSA BPM Guide, documentaci\u00f3n"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "9207263c-91f1-4ea7-a122-4b89c46388d1", "node_type": "4", "metadata": {"page_label": "6", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "6686dd5269047d8b90d9a94e5073046f0f2d802fff92d4da59accd7bce72206c", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "f724c83d-1d00-4bb4-9763-3d6f1b0412e3", "node_type": "1", "metadata": {"page_label": "5", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29"}, "hash": "b25c371956866c10cbe3fc6bf0a7f89ad9d4c22af9a6cf0404f751dac76f4e7d", "class_name": "RelatedNodeInfo"}}, "text": "|requerimiento|recalificacion|si|no|na|\n|---|---|---|---|---|\n|?se realiza la recalificacion de sistemas y equipos de acuerdo a un programa definido? (la frecuencia de recalificacion puede ser determinada basandose en factores tales como los analisis de los resultados relativos a calibracion, verificacion y mantencion.)| |x| | |\n|?se realiza recalificacion periodica?| |x| | |\n|?se realiza recalificacion despues de cambios?| |x| | |\n|?se justifica en base a una evaluacion de riesgo del cambio, la extension de la recalificacion despues de cambios?| |x| | |\n|?se considera la recalificacion despues de cambios, como parte del procedimiento de control de cambios?| |x| | |\n\n|calificacion de sistemas y equipos \"en uso\"|requerimiento|si|no|na|\n|---|---|---|---|---|\n| |?cuenta con datos que respalden y verifiquen la adecuada operacion y desempeno de los sistemas y equipos que han estado \"en uso\" durante un periodo de tiempo y los cuales no han sido objeto de calificacion de instalacion y/o de operacion?|x| | |\n| |?los datos incluyen los parametros de operacion y limites para variables criticas, calibracion, mantencion y mantencion preventiva, procedimientos operativos estandar (poss) y registros?|x| | |", "start_char_idx": 0, "end_char_idx": 1212, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}}, "docstore/metadata": {"1527b74a-58f0-45d9-a30f-8aae2d533c72": {"doc_hash": "a5c820a1703873b122e8dab6459df84cc4e2b168f4ff0d002483f532abadc484", "ref_doc_id": "e9a03e57-245a-484b-a7b7-0e2864663485"}, "dd4f2265-8028-4ec4-ae6f-2813d6c00d65": {"doc_hash": "68a8da7b98d6a3860e4d2995340a7df97bd6d0fd10efe506e6962d42cd5755fa", "ref_doc_id": "a92f65ac-54e1-4bd9-94bb-340b16053a97"}, "6d47894f-e752-422b-811f-734b30aeda01": {"doc_hash": "f55d9fbc145d62b0b39df97af6223620d779135969c708004fce79cf72e9c7ed", "ref_doc_id": "a92f65ac-54e1-4bd9-94bb-340b16053a97"}, "64ee46b7-7679-454a-8140-766579dea8a1": {"doc_hash": "0cb3ac798ab2e254dae6836d8ca4c92f7026be8d40a08b571744abe151c937be", "ref_doc_id": "e9556713-0f31-4fa1-8f89-4a7bd72bc71b"}, "d9a34d84-f18d-4d11-a733-2c0e17d86337": {"doc_hash": "778b7002622a18d0d42eb1b6c5f75aacad0fc73d35e91846f174e260c782cc53", "ref_doc_id": "dddfde13-1961-4715-b982-19a9e0560a19"}, "f724c83d-1d00-4bb4-9763-3d6f1b0412e3": {"doc_hash": "32aeb9e95acc2d8e28e4b63b4c283381db85fc48bd76fea796a97d775e41baca", "ref_doc_id": "c4125bdf-12a6-4e00-bf1e-870259fffc4d"}, "eac0e653-1ea8-40f9-bb4c-aad5c47c0834": {"doc_hash": "d133a8228ba51f409510f09204b238cfd95bd70d5151b427d8d20aeb8a985996", "ref_doc_id": "9207263c-91f1-4ea7-a122-4b89c46388d1"}}, "docstore/ref_doc_info": {"e9a03e57-245a-484b-a7b7-0e2864663485": {"node_ids": ["1527b74a-58f0-45d9-a30f-8aae2d533c72"], "metadata": {"page_label": "1", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Validation and Change Control of Computerized Systems", "questions_this_excerpt_can_answer": "1. What are the specific stages included in the computerized system validation process according to the \"GU\u00cdA BPM ARCSA 2020\" document?\n2. Does the \"GU\u00cdA BPM ARCSA 2020\" outline requirements for periodic evaluation after the initial validation of computerized systems, and if so, what does this evaluation entail?\n3. How does the \"GU\u00cdA BPM ARCSA 2020\" document address the considerations for environmental factors such as location, power source, temperature, and magnetic disturbances in the use of computerized systems?", "excerpt_keywords": "Computerized system validation, Change control, Environmental factors, Periodic evaluation, Data integrity"}}, "a92f65ac-54e1-4bd9-94bb-340b16053a97": {"node_ids": ["dd4f2265-8028-4ec4-ae6f-2813d6c00d65", "6d47894f-e752-422b-811f-734b30aeda01"], "metadata": {"page_label": "2", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Seguridad y validaci\u00f3n de sistemas computarizados para la manipulaci\u00f3n de datos autorizados.", "questions_this_excerpt_can_answer": "1. What specific security measures are outlined in the \"GU\u00cdA BPM ARCSA 2020\" for preventing unauthorized data access or manipulation in computerized systems used for handling authorized data within the pharmaceutical industry in Ecuador?\n\n2. How does the \"GU\u00cdA BPM ARCSA 2020\" document address the validation and verification process for critical data entry into computer systems by authorized personnel, including the requirement for independent verification and release for use by a second authorized person?\n\n3. What are the requirements and procedures detailed in the \"GU\u00cdA BPM ARCSA 2020\" for creating, maintaining, and storing backup copies of all files and data to prevent intentional or accidental damage, as part of ensuring data integrity and security in computerized systems within the pharmaceutical sector?", "prev_section_summary": "The section discusses the validation and change control of computerized systems according to the \"GU\u00cdA BPM ARCSA 2020\" document. Key topics include the stages of the validation process, requirements for periodic evaluation after initial validation, considerations for environmental factors, specifications of the system, monitoring performance, control of changes, and data integrity. Entities mentioned include hardware, software, users, system specifications, and data validation processes.", "excerpt_keywords": "Seguridad, validaci\u00f3n, sistemas computarizados, manipulaci\u00f3n de datos, procedimientos operativos est\u00e1ndar"}}, "e9556713-0f31-4fa1-8f89-4a7bd72bc71b": {"node_ids": ["64ee46b7-7679-454a-8140-766579dea8a1"], "metadata": {"page_label": "3", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Validation and Calibration of Hardware and Software in Command Overrides: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific criteria are outlined in the \"GU\u00cdA BPM ARCSA 2020\" for validating and calibrating hardware in terms of its operational limits and performance under worst-case scenarios?\n \n2. How does the \"GU\u00cdA BPM ARCSA 2020\" document address the responsibility of maintaining hardware validation data when the validation is performed by an external company, such as a computer supplier?\n\n3. According to the \"GU\u00cdA BPM ARCSA 2020\" guide, what are the key aspects of software validation, including the validation of the software's language and level, as outlined in the context provided?", "prev_section_summary": "The section discusses the validation requirements for hardware and software in computerized systems according to the 2020 ARCSA BPM Guide for the pharmaceutical industry in Ecuador. It outlines the specific components that need to be validated, such as input and output devices, signal converters, the central processing unit (CPU), system distribution, peripheral devices, and key aspects related to location, environmental considerations, and signal conversion. The excerpt emphasizes the importance of evaluating and qualifying system performance, change control, maintenance, calibration, security, contingency planning, training, performance monitoring, and periodic reevaluation for ensuring data integrity and security in pharmaceutical operations.", "excerpt_keywords": "Validation, Calibration, Hardware, Software, ARCSA BPM Guide"}}, "dddfde13-1961-4715-b982-19a9e0560a19": {"node_ids": ["d9a34d84-f18d-4d11-a733-2c0e17d86337"], "metadata": {"page_label": "4", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Validaci\u00f3n y Calificaci\u00f3n de Sistemas y Equipos en Desarrollo de Software: Proceso y Metodolog\u00edas.", "questions_this_excerpt_can_answer": "1. What specific criteria are outlined in the \"GU\u00cdA BPM ARCSA 2020\" for identifying key aspects of computer programs used in pharmaceutical manufacturing, including their language, function, and input/output processes?\n\n2. How does the \"GU\u00cdA BPM ARCSA 2020\" define the process and methodologies for validating software to ensure it performs consistently within pre-established limits, especially those controlling manufacturing and processes in the pharmaceutical industry?\n\n3. According to the \"GU\u00cdA BPM ARCSA 2020,\" what are the requirements for the qualification of systems and equipment in a laboratory setting to ensure they are appropriately designed, located, installed, operated, and maintained for their intended purpose?", "prev_section_summary": "The section discusses the validation and calibration of hardware and software in command overrides, as outlined in the \"GU\u00cdA BPM ARCSA 2020\" document. Key topics include the validation criteria for hardware, such as operational limits, performance under worst-case scenarios, reproducibility/consistency, and revalidation. The responsibility of maintaining hardware validation data when performed by an external company is also addressed. Additionally, the key aspects of software validation, including the validation of software language and level, are outlined. The section emphasizes the importance of ensuring hardware operates within its assigned function, operational limits, and under worst-case conditions, as well as the validation of software aspects like level and language.", "excerpt_keywords": "software validation, equipment qualification, pharmaceutical manufacturing, system design, document control"}}, "c4125bdf-12a6-4e00-bf1e-870259fffc4d": {"node_ids": ["f724c83d-1d00-4bb4-9763-3d6f1b0412e3"], "metadata": {"page_label": "5", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "\"Assessment of Systems and Equipment in Production and Quality Control\"", "questions_this_excerpt_can_answer": "1. What specific stages of qualification are mentioned for new systems and equipment before they are used in production and quality control according to the 2020 ARCSA BPM Guide?\n \n2. How does the 2020 ARCSA BPM Guide address the need for periodic requalification and requalification after changes for systems and equipment used in production and quality control environments?\n\n3. According to the 2020 ARCSA BPM Guide, are there any specific annexes that provide guidelines on the qualification of water purification systems and heating, ventilation, and air conditioning (HVAC) systems?", "prev_section_summary": "The section discusses the validation and qualification of systems and equipment in software development, specifically focusing on pharmaceutical manufacturing. Key topics include identifying key aspects of computer programs, validation processes, software security, program overrides, documentation requirements, and the qualification of critical systems and equipment in a laboratory setting. The section emphasizes the importance of ensuring software consistency within pre-established limits and the appropriate design, installation, operation, and maintenance of equipment for their intended purpose. Key entities mentioned include software programs, input/output processes, validation criteria, personnel authorized to access programs, and the need for protocols and reports during validation processes.", "excerpt_keywords": "Qualification, Systems, Equipment, Production, Quality Control"}}, "9207263c-91f1-4ea7-a122-4b89c46388d1": {"node_ids": ["eac0e653-1ea8-40f9-bb4c-aad5c47c0834"], "metadata": {"page_label": "6", "file_name": "[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Ecuador/[31] GU\u00cdA BPM ARCSA 2020 (software).pdf", "file_type": "application/pdf", "file_size": 354274, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Recalificaci\u00f3n y Verificaci\u00f3n de Sistemas y Equipos en Uso: Proceso y Procedimientos.", "questions_this_excerpt_can_answer": "1. How does the 2020 ARCSA BPM Guide address the requirement for recalification of systems and equipment in use, specifically in terms of a defined program and the factors considered for determining recalification frequency?\n \n2. What criteria does the 2020 ARCSA BPM Guide specify for justifying the extension of recalification after changes to systems and equipment, including the role of risk evaluation in this process?\n\n3. According to the 2020 ARCSA BPM Guide, what documentation and data are required to support and verify the proper operation and performance of systems and equipment that have been in use over time without undergoing installation and/or operation qualification?", "prev_section_summary": "This section discusses the assessment of systems and equipment in production and quality control according to the 2020 ARCSA BPM Guide. It covers topics such as the stages of qualification for new systems and equipment, the need for periodic requalification and requalification after changes, specific annexes providing guidelines for water purification systems and HVAC systems, and the requirements for design qualification, installation qualification, and operational qualification. The section emphasizes the importance of following predetermined and approved qualification protocols, documenting the results of qualification, and ensuring the proper installation, calibration, and maintenance of systems and equipment.", "excerpt_keywords": "Recalificaci\u00f3n, sistemas, equipos, ARCSA BPM Guide, documentaci\u00f3n"}}}} |