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vec_25_di/storage_nodes/graph_store.json

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+{"graph_dict": {}}

vec_25_di/storage_nodes/image__vector_store.json

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+{"embedding_dict": {}, "text_id_to_ref_doc_id": {}, "metadata_dict": {}}

vec_25_di/storage_nodes/index_store.json

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+{"index_store/data": {"vector_index": {"__type__": "vector_store", "__data__": "{\"index_id\": \"vector_index\", \"summary\": null, \"nodes_dict\": {\"e1e5a19c-05b4-4243-b479-282e27889866\": \"e1e5a19c-05b4-4243-b479-282e27889866\", \"fa7f805c-e36e-4ec7-9b3d-cddc62ad4bc4\": \"fa7f805c-e36e-4ec7-9b3d-cddc62ad4bc4\", \"82d44838-4d60-4139-bf3a-c7ccd436f631\": \"82d44838-4d60-4139-bf3a-c7ccd436f631\", \"fe481ba9-466b-4cbc-828e-e6e86b4f5556\": \"fe481ba9-466b-4cbc-828e-e6e86b4f5556\", \"ebeae8ce-2e2c-4de5-9f51-4ff5303e7553\": \"ebeae8ce-2e2c-4de5-9f51-4ff5303e7553\", \"9f7b711f-8e1d-4d66-a2d8-43fd1dcee07d\": \"9f7b711f-8e1d-4d66-a2d8-43fd1dcee07d\"}, \"doc_id_dict\": {}, \"embeddings_dict\": {}}"}}}

vec_26_di/storage_nodes/graph_store.json

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+{"graph_dict": {}}

vec_26_di/storage_nodes/image__vector_store.json

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+{"embedding_dict": {}, "text_id_to_ref_doc_id": {}, "metadata_dict": {}}

vec_26_di/storage_nodes/index_store.json

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+{"index_store/data": {"vector_index": {"__type__": "vector_store", "__data__": "{\"index_id\": \"vector_index\", \"summary\": null, \"nodes_dict\": {\"b901326a-6419-4efa-8e83-2d75d53ea396\": \"b901326a-6419-4efa-8e83-2d75d53ea396\", \"ec401d05-e382-4702-a4ea-1061b3d1faf9\": \"ec401d05-e382-4702-a4ea-1061b3d1faf9\", \"88b76b78-ba17-44ed-827c-887db64134f8\": \"88b76b78-ba17-44ed-827c-887db64134f8\", \"fb6c1961-61c2-4ba7-bbb5-534f185f29f4\": \"fb6c1961-61c2-4ba7-bbb5-534f185f29f4\", \"c6fca507-bb22-4b3f-b554-db9a63425bea\": \"c6fca507-bb22-4b3f-b554-db9a63425bea\", \"0aef7488-35e9-4c39-bee4-85a753e1278b\": \"0aef7488-35e9-4c39-bee4-85a753e1278b\"}, \"doc_id_dict\": {}, \"embeddings_dict\": {}}"}}}

vec_27_di/storage_nodes/docstore.json

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+{"docstore/data": {"d5ce33e2-6e3a-42b9-a877-ee52f57b1cd1": {"__data__": {"id_": "d5ce33e2-6e3a-42b9-a877-ee52f57b1cd1", "embedding": null, "metadata": {"page_label": "1", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "Colombia/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "image_path": "", "parsed_text_markdown": "# General European OMCL Network (GEON)\n## QUALITY MANAGEMENT DOCUMENT\n\n**PA/PH/OMCL (08) 88 R5**\n\n**VALIDATION OF COMPUTERISED SYSTEMS**\n**ANNEX 2 \u2013 VALIDATION OF COMPLEX COMPUTERISED SYSTEMS**\n\n|                                                           |                                                                                                                                                                                           |\n| --------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| **Full document title and reference**                     | Validation of Computerised Systems Annex 2 \u2013 Validation of Complex Computerised Systems PA/PH/OMCL (08) 88 R5                                                                             |\n| **Document type**                                         | Guideline                                                                                                                                                                                 |\n| **Legislative basis**                                     | -                                                                                                                                                                                         |\n| **Date of first adoption**                                | May 2009                                                                                                                                                                                  |\n| **Date of original entry into force**                     | July 2009                                                                                                                                                                                 |\n| **Date of entry into force of revised document**          | August 2018                                                                                                                                                                               |\n| **Previous titles/other references / last valid version** | Validation of Computerised Systems Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN) PA/PH/OMCL (08) 88 R |\n| **Custodian Organisation**                                | The present document was elaborated by the OMCL Network / EDQM of the Council of Europe                                                                                                   |\n| **Concerned Network**                                     | GEON                                                                                                                                                                                      |\n", "parsed_text": "", "document_title": "PA-PH-OMCL (08) 88 R5 Annex 2 - Validation of Complex Computerised Systems", "questions_this_excerpt_can_answer": "Aqu\u00ed tienes tres preguntas que se pueden formular a partir del contexto proporcionado, junto con sus respuestas espec\u00edficas:\n\n1. **\u00bfCu\u00e1l es la fecha de entrada en vigor del documento revisado sobre la validaci\u00f3n de sistemas computarizados?**\n   - **Respuesta:** La fecha de entrada en vigor del documento revisado es agosto de 2018.\n\n2. **\u00bfQu\u00e9 organizaci\u00f3n es responsable de la elaboraci\u00f3n del documento PA/PH/OMCL (08) 88 R5?**\n   - **Respuesta:** El documento fue elaborado por la Red OMCL / EDQM del Consejo de Europa.\n\n3. **\u00bfCu\u00e1l es el t\u00edtulo anterior del documento que se menciona en el contexto?**\n   - **Respuesta:** El t\u00edtulo anterior del documento es \"Validation of Computerised Systems Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN) PA/PH/OMCL (08) 88 R\".\n\n### Resumen de nivel superior del contexto:\nEl documento PA/PH/OMCL (08) 88 R5 es una gu\u00eda sobre la validaci\u00f3n de sistemas computarizados, espec\u00edficamente enfoc\u00e1ndose en sistemas complejos. Fue adoptado por primera vez en mayo de 2009 y ha sido revisado, con la versi\u00f3n actual en vigor desde agosto de 2018. La gu\u00eda es parte de los esfuerzos de la Red OMCL y est\u00e1 destinada a asegurar la calidad en la gesti\u00f3n de sistemas computarizados en el \u00e1mbito de la salud y la investigaci\u00f3n.", "excerpt_keywords": "Keywords: validation, computerized systems, OMCL Network, guideline, quality management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "061b05f4-5cde-4fbe-ba22-cbb49f5b11af", "node_type": "4", "metadata": {"page_label": "1", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "Colombia/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "image_path": "", "parsed_text_markdown": "# General European OMCL Network (GEON)\n## QUALITY MANAGEMENT DOCUMENT\n\n**PA/PH/OMCL (08) 88 R5**\n\n**VALIDATION OF COMPUTERISED SYSTEMS**\n**ANNEX 2 \u2013 VALIDATION OF COMPLEX COMPUTERISED SYSTEMS**\n\n|                                                           |                                                                                                                                                                                           |\n| --------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| **Full document title and reference**                     | Validation of Computerised Systems Annex 2 \u2013 Validation of Complex Computerised Systems PA/PH/OMCL (08) 88 R5                                                                             |\n| **Document type**                                         | Guideline                                                                                                                                                                                 |\n| **Legislative basis**                                     | -                                                                                                                                                                                         |\n| **Date of first adoption**                                | May 2009                                                                                                                                                                                  |\n| **Date of original entry into force**                     | July 2009                                                                                                                                                                                 |\n| **Date of entry into force of revised document**          | August 2018                                                                                                                                                                               |\n| **Previous titles/other references / last valid version** | Validation of Computerised Systems Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN) PA/PH/OMCL (08) 88 R |\n| **Custodian Organisation**                                | The present document was elaborated by the OMCL Network / EDQM of the Council of Europe                                                                                                   |\n| **Concerned Network**                                     | GEON                                                                                                                                                                                      |\n", "parsed_text": "", "document_title": "PA-PH-OMCL (08) 88 R5 Annex 2 - Validation of Complex Computerised Systems"}, "hash": "c2e07fb69d3b7e9231b5c2fd1ca8ec6b198ac7cde54aeab5f13258dc9f292923", "class_name": "RelatedNodeInfo"}}, "metadata_template": "{key}: {value}", "metadata_separator": "\n", "text": "# General European OMCL Network (GEON)\n## QUALITY MANAGEMENT DOCUMENT\n\n**PA/PH/OMCL (08) 88 R5**\n\n**VALIDATION OF COMPUTERISED SYSTEMS**\n**ANNEX 2 \u2013 VALIDATION OF COMPLEX COMPUTERISED SYSTEMS**\n\n|                                                           |                                                                                                                                                                                           |\n| --------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| **Full document title and reference**                     | Validation of Computerised Systems Annex 2 \u2013 Validation of Complex Computerised Systems PA/PH/OMCL (08) 88 R5                                                                             |\n| **Document type**                                         | Guideline                                                                                                                                                                                 |\n| **Legislative basis**                                     | -                                                                                                                                                                                         |\n| **Date of first adoption**                                | May 2009                                                                                                                                                                                  |\n| **Date of original entry into force**                     | July 2009                                                                                                                                                                                 |\n| **Date of entry into force of revised document**          | August 2018                                                                                                                                                                               |\n| **Previous titles/other references / last valid version** | Validation of Computerised Systems Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN) PA/PH/OMCL (08) 88 R |\n| **Custodian Organisation**                                | The present document was elaborated by the OMCL Network / EDQM of the Council of Europe                                                                                                   |\n| **Concerned Network**                                     | GEON                                                                                                                                                                                      |", "mimetype": "text/plain", "start_char_idx": 0, "end_char_idx": 2944, "metadata_seperator": "\n", "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "class_name": "TextNode"}, "__type__": "1"}, "9d55f4a2-9d3f-462d-b909-1f337509e18b": {"__data__": {"id_": "9d55f4a2-9d3f-462d-b909-1f337509e18b", "embedding": null, "metadata": {"page_label": "2", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "Colombia/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "image_path": "", "parsed_text_markdown": "# ANNEX 2 OF THE OMCL NETWORK GUIDELINE\n\u201cVALIDATION OF COMPUTERISED SYSTEMS\u201d\n\n## VALIDATION OF COMPLEX COMPUTERISED SYSTEMS\n\n*Note: Mandatory requirements in this guideline and its annexes are defined using the terms \u00abshall\u00bb or \u00abmust\u00bb. The use of \u00abshould\u00bb indicates a recommendation. For these parts of the text other appropriately justified approaches are acceptable. The term \u00abcan\u00bb indicates a possibility or an example with non-binding character.*\n\n### 1. INTRODUCTION\n\nThis is the 2nd Annex of the core document \u201cValidation of Computerised Systems\u201d, and it should be used in combination with the latter when planning, performing and documenting the validation steps of complex computerised systems. Excel spreadsheet validation is described in the 1st Annex of the core document and not subjected here.\n\n### 2. USER REQUIREMENTS SPECIFICATIONS (URS)\n\nThe selection and purchase of new software and the associated computer and laboratory equipment should follow a conscious decision-making process based on the requirements for the intended use of the computerised system. A User Requirements Specification (URS) should describe the functional and technical requirements of the computerised system, as defined by the OMCL, in terms of both software and hardware. It should also cover the aspects of information security and data integrity.\n\nSome of the items that can be included are:\n\na) Description of the software used (e.g. Excel, Access, Oracle), including version;\nb) Requirements on hardware components and operating system;\nc) Description of functions;\nd) Description of the attributes of data;\ne) Terminology (e.g. important especially for the consistent description of input masks / fields);\nf) Database design, including masks and fields as well as a map of the data relationships;\ng) Specifications of macros, formulas and control commands;\nh) Specifications of the data inputs (e.g. format, decimal places, units);\ni) Specification of the mandatory fields for data;\nj) Specifications of the protection of masks, working sheets or the whole application;\nk) Planning of the data migration, if applicable;\nl) Specifications for traceability of data entry and changes (audit trail) of interfaces to other system components, if applicable.\n\nThe URS shall be released by a responsible person. Changes to the requirements are possible but the changes should be traceable and the URS document should be version controlled or an equivalent system established in order to ensure traceability. New or changed requirements should be communicated to all persons involved.", "parsed_text": "", "document_title": "PA-PH-OMCL (08) 88 R5 Annex 2 - Validation of Complex Computerised Systems", "questions_this_excerpt_can_answer": "Aqu\u00ed tienes tres preguntas espec\u00edficas que se pueden responder con el contexto proporcionado, as\u00ed como un resumen de nivel superior:\n\n### Resumen de Nivel Superior\nEl documento es el Anexo 2 de la gu\u00eda de la Red OMCL sobre la validaci\u00f3n de sistemas computarizados complejos. Se centra en la importancia de las Especificaciones de Requisitos del Usuario (URS) para la selecci\u00f3n y compra de software y equipos relacionados. Se enfatiza que la URS debe detallar los requisitos funcionales y t\u00e9cnicos, as\u00ed como aspectos de seguridad de la informaci\u00f3n e integridad de los datos. Adem\u00e1s, se menciona la necesidad de un control de versiones y trazabilidad en los cambios de requisitos.\n\n### Preguntas Espec\u00edficas\n\n1. **\u00bfQu\u00e9 elementos espec\u00edficos deben incluirse en una Especificaci\u00f3n de Requisitos del Usuario (URS) para un sistema computarizado complejo?**\n   - La URS debe incluir elementos como la descripci\u00f3n del software y su versi\u00f3n, requisitos de hardware y sistema operativo, descripci\u00f3n de funciones, atributos de datos, dise\u00f1o de base de datos, especificaciones de macros y f\u00f3rmulas, y requisitos de trazabilidad de datos, entre otros.\n\n2. **\u00bfCu\u00e1l es la importancia de la trazabilidad en la gesti\u00f3n de cambios de la URS?**\n   - La trazabilidad es crucial para asegurar que cualquier cambio en los requisitos sea documentado y comunicado a todas las partes involucradas. Esto ayuda a mantener la integridad del proceso de validaci\u00f3n y asegura que todos los cambios sean controlados y justificados.\n\n3. **\u00bfQu\u00e9 papel juega la seguridad de la informaci\u00f3n en la URS seg\u00fan el documento?**\n   - La URS debe abordar aspectos de seguridad de la informaci\u00f3n y de integridad de los datos, asegurando que el sistema computarizado cumpla con los est\u00e1ndares necesarios para proteger la informaci\u00f3n sensible y garantizar que los datos sean precisos y confiables.", "prev_section_summary": "El documento PA/PH/OMCL (08) 88 R5 es una gu\u00eda que aborda la validaci\u00f3n de sistemas computarizados, con un enfoque particular en sistemas complejos. A continuaci\u00f3n se presentan los temas clave y entidades mencionadas en la secci\u00f3n:\n\n### Temas Clave:\n1. **Validaci\u00f3n de Sistemas Computarizados**: El documento proporciona directrices sobre c\u00f3mo validar sistemas computarizados en el contexto de la salud y la investigaci\u00f3n.\n2. **Revisi\u00f3n y Actualizaci\u00f3n**: Se menciona la fecha de primera adopci\u00f3n (mayo de 2009) y las fechas de entrada en vigor de la versi\u00f3n original (julio de 2009) y la versi\u00f3n revisada (agosto de 2018).\n3. **Documentaci\u00f3n y Referencias**: Incluye informaci\u00f3n sobre t\u00edtulos anteriores y referencias relacionadas con la validaci\u00f3n de bases de datos, sistemas de gesti\u00f3n de informaci\u00f3n de laboratorio y cuadernos de laboratorio electr\u00f3nicos.\n\n### Entidades:\n- **Organizaci\u00f3n Custodia**: OMCL Network / EDQM del Consejo de Europa, responsable de la elaboraci\u00f3n del documento.\n- **Red Concernida**: General European OMCL Network (GEON), que se ocupa de la calidad en la gesti\u00f3n de sistemas computarizados.\n\nEste resumen destaca la importancia del documento en la regulaci\u00f3n y aseguramiento de la calidad de los sistemas computarizados en el \u00e1mbito de la salud, as\u00ed como su evoluci\u00f3n a lo largo del tiempo.", "excerpt_keywords": "Keywords: validation, computerized systems, user requirements specification, data integrity, information security"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "29bf79f7-7153-4187-bbc4-2a6c440e5ae0", "node_type": "4", "metadata": {"page_label": "2", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "Colombia/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "image_path": "", "parsed_text_markdown": "# ANNEX 2 OF THE OMCL NETWORK GUIDELINE\n\u201cVALIDATION OF COMPUTERISED SYSTEMS\u201d\n\n## VALIDATION OF COMPLEX COMPUTERISED SYSTEMS\n\n*Note: Mandatory requirements in this guideline and its annexes are defined using the terms \u00abshall\u00bb or \u00abmust\u00bb. The use of \u00abshould\u00bb indicates a recommendation. For these parts of the text other appropriately justified approaches are acceptable. The term \u00abcan\u00bb indicates a possibility or an example with non-binding character.*\n\n### 1. INTRODUCTION\n\nThis is the 2nd Annex of the core document \u201cValidation of Computerised Systems\u201d, and it should be used in combination with the latter when planning, performing and documenting the validation steps of complex computerised systems. Excel spreadsheet validation is described in the 1st Annex of the core document and not subjected here.\n\n### 2. USER REQUIREMENTS SPECIFICATIONS (URS)\n\nThe selection and purchase of new software and the associated computer and laboratory equipment should follow a conscious decision-making process based on the requirements for the intended use of the computerised system. A User Requirements Specification (URS) should describe the functional and technical requirements of the computerised system, as defined by the OMCL, in terms of both software and hardware. It should also cover the aspects of information security and data integrity.\n\nSome of the items that can be included are:\n\na) Description of the software used (e.g. Excel, Access, Oracle), including version;\nb) Requirements on hardware components and operating system;\nc) Description of functions;\nd) Description of the attributes of data;\ne) Terminology (e.g. important especially for the consistent description of input masks / fields);\nf) Database design, including masks and fields as well as a map of the data relationships;\ng) Specifications of macros, formulas and control commands;\nh) Specifications of the data inputs (e.g. format, decimal places, units);\ni) Specification of the mandatory fields for data;\nj) Specifications of the protection of masks, working sheets or the whole application;\nk) Planning of the data migration, if applicable;\nl) Specifications for traceability of data entry and changes (audit trail) of interfaces to other system components, if applicable.\n\nThe URS shall be released by a responsible person. Changes to the requirements are possible but the changes should be traceable and the URS document should be version controlled or an equivalent system established in order to ensure traceability. New or changed requirements should be communicated to all persons involved.", "parsed_text": "", "document_title": "PA-PH-OMCL (08) 88 R5 Annex 2 - Validation of Complex Computerised Systems"}, "hash": "e4d9152da5d6f56690ae01b9a1b5067cfef3cb46908585b534f00f7844782369", "class_name": "RelatedNodeInfo"}}, "metadata_template": "{key}: {value}", "metadata_separator": "\n", "text": "# ANNEX 2 OF THE OMCL NETWORK GUIDELINE\n\u201cVALIDATION OF COMPUTERISED SYSTEMS\u201d\n\n## VALIDATION OF COMPLEX COMPUTERISED SYSTEMS\n\n*Note: Mandatory requirements in this guideline and its annexes are defined using the terms \u00abshall\u00bb or \u00abmust\u00bb. The use of \u00abshould\u00bb indicates a recommendation. For these parts of the text other appropriately justified approaches are acceptable. The term \u00abcan\u00bb indicates a possibility or an example with non-binding character.*\n\n### 1. INTRODUCTION\n\nThis is the 2nd Annex of the core document \u201cValidation of Computerised Systems\u201d, and it should be used in combination with the latter when planning, performing and documenting the validation steps of complex computerised systems. Excel spreadsheet validation is described in the 1st Annex of the core document and not subjected here.\n\n### 2. USER REQUIREMENTS SPECIFICATIONS (URS)\n\nThe selection and purchase of new software and the associated computer and laboratory equipment should follow a conscious decision-making process based on the requirements for the intended use of the computerised system. A User Requirements Specification (URS) should describe the functional and technical requirements of the computerised system, as defined by the OMCL, in terms of both software and hardware. It should also cover the aspects of information security and data integrity.\n\nSome of the items that can be included are:\n\na) Description of the software used (e.g. Excel, Access, Oracle), including version;\nb) Requirements on hardware components and operating system;\nc) Description of functions;\nd) Description of the attributes of data;\ne) Terminology (e.g. important especially for the consistent description of input masks / fields);\nf) Database design, including masks and fields as well as a map of the data relationships;\ng) Specifications of macros, formulas and control commands;\nh) Specifications of the data inputs (e.g. format, decimal places, units);\ni) Specification of the mandatory fields for data;\nj) Specifications of the protection of masks, working sheets or the whole application;\nk) Planning of the data migration, if applicable;\nl) Specifications for traceability of data entry and changes (audit trail) of interfaces to other system components, if applicable.\n\nThe URS shall be released by a responsible person. Changes to the requirements are possible but the changes should be traceable and the URS document should be version controlled or an equivalent system established in order to ensure traceability. New or changed requirements should be communicated to all persons involved.", "mimetype": "text/plain", "start_char_idx": 0, "end_char_idx": 2574, "metadata_seperator": "\n", "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "class_name": "TextNode"}, "__type__": "1"}, "ea6d1619-4507-4b1c-9937-17b1edc6017c": {"__data__": {"id_": "ea6d1619-4507-4b1c-9937-17b1edc6017c", "embedding": null, "metadata": {"page_label": "3", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "Colombia/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "image_path": "", "parsed_text_markdown": "# 3. INSTALLATION QUALIFICATION (IQ)\n\nThe correct installation of the system in the IT environment with defined hardware and operating software shall be documented and tested. Detailed installation procedures should be available and carried out by well-trained personnel only.\n\nChecklists with predefined installation steps and acceptance criteria can ensure the correct installation of the system and the traceable qualification of the installation.\n\nIn most cases, the computerised system is connected to a computer network with interfaces to other software (other applications) and hardware (computer equipment or laboratory equipment). It must be ensured that the system is correctly integrated and that all components are operative.\n\nThe IQ typically includes:\n\na) A check of the required system resources both of the server and client, when applicable (e.g. supported operating system, database engine, performance of the processor, free space on the hard disk, memory, access rights for installations);\n\nb) Documentation of the components of the system (as a minimum, a description of the components and version of the relevant components with date of implementation);\n\nc) List of users or user groups with access to the application, including type of access;\n\nd) Integration test and/or communication test for the interfaces to other systems/equipment.\n\nOften the installation is supported by the supplier and the internal IT unit.\n\n# 4. OPERATIONAL QUALIFICATION (OQ)\n\nThe proper functioning of the software shall be checked by testing the key functions, e.g. calibration and quantification (internal standards, external standards), peak identification, and calculation of system suitability parameters.\n\nIdeally, a raw data set can be used for which the results are known. These raw data sets are often provided by the supplier of the software, are processed by the software and the results are then compared to the expected values.\n\nIf no such data sets are available, example raw data sets can be acquired by running typical samples. The results of the processed raw data sets should be verified by recalculating the key parameters (e.g. calibration curves from peak areas of standards) using standard (e.g., spreadsheet) software.\n\nRaw data from the testing of functions affecting the measurement result and its associated measurement uncertainty (input and output data, screenshots) shall be documented within the qualification report.\n\nOperational qualification should be repeated in a risk-based approach after installation of new software modules, new software versions, new service packs, patch updates, or after major changes in the software structure of the computer (e.g. new anti-virus software). A similar approach should be taken for every change in hardware platform or system upgrades.", "parsed_text": "", "document_title": "PA-PH-OMCL (08) 88 R5 Annex 2 - Validation of Complex Computerised Systems", "questions_this_excerpt_can_answer": "Aqu\u00ed tienes tres preguntas espec\u00edficas que se pueden responder con el contexto proporcionado, junto con un resumen de nivel superior:\n\n### Resumen de Nivel Superior\nEl documento aborda la validaci\u00f3n de sistemas inform\u00e1ticos complejos, centr\u00e1ndose en dos etapas clave: la Calificaci\u00f3n de Instalaci\u00f3n (IQ) y la Calificaci\u00f3n Operativa (OQ). La IQ se enfoca en asegurar que el sistema est\u00e9 correctamente instalado y documentado, incluyendo la verificaci\u00f3n de recursos del sistema, documentaci\u00f3n de componentes y pruebas de integraci\u00f3n. Por otro lado, la OQ se centra en comprobar el funcionamiento adecuado del software mediante pruebas de funciones clave y la comparaci\u00f3n de resultados con valores esperados, adem\u00e1s de la necesidad de repetir estas pruebas tras cambios significativos en el software o hardware.\n\n### Preguntas Espec\u00edficas\n\n1. **\u00bfQu\u00e9 tipo de documentaci\u00f3n se requiere para la Calificaci\u00f3n de Instalaci\u00f3n (IQ) y por qu\u00e9 es importante?**\n   - La IQ requiere documentaci\u00f3n que incluya una descripci\u00f3n de los componentes del sistema, versiones relevantes y fechas de implementaci\u00f3n, as\u00ed como una lista de usuarios con acceso y sus tipos de acceso. Esta documentaci\u00f3n es crucial para garantizar que la instalaci\u00f3n se realice de manera correcta y que se pueda rastrear la calificaci\u00f3n de la instalaci\u00f3n.\n\n2. **\u00bfCu\u00e1les son los pasos recomendados para llevar a cabo la Calificaci\u00f3n Operativa (OQ) y qu\u00e9 tipo de datos se deben documentar?**\n   - Para la OQ, se deben realizar pruebas de funciones clave del software, utilizando conjuntos de datos en los que se conocen los resultados esperados. Los datos de entrada y salida, as\u00ed como capturas de pantalla, deben ser documentados en el informe de calificaci\u00f3n para asegurar la trazabilidad y la verificaci\u00f3n de los resultados.\n\n3. **\u00bfQu\u00e9 condiciones pueden requerir la repetici\u00f3n de la Calificaci\u00f3n Operativa (OQ) y por qu\u00e9 es relevante un enfoque basado en riesgos?**\n   - La OQ debe repetirse tras la instalaci\u00f3n de nuevos m\u00f3dulos de software, actualizaciones de versiones, o cambios significativos en la estructura del software o hardware. Un enfoque basado en riesgos es relevante porque permite priorizar las pruebas en funci\u00f3n de la magnitud del cambio y su posible impacto en el funcionamiento del sistema, asegurando as\u00ed la integridad y confiabilidad del software.", "prev_section_summary": "### Resumen de Temas Clave y Entidades\n\n**Tema Principal:**\n- Validaci\u00f3n de Sistemas Computarizados Complejos: El documento se centra en la validaci\u00f3n de sistemas computarizados complejos, proporcionando directrices sobre c\u00f3mo llevar a cabo este proceso de manera efectiva.\n\n**Subtemas:**\n1. **Especificaciones de Requisitos del Usuario (URS):**\n   - Importancia de la URS en la selecci\u00f3n y compra de software y equipos.\n   - Detalle de requisitos funcionales y t\u00e9cnicos, as\u00ed como aspectos de seguridad de la informaci\u00f3n e integridad de los datos.\n\n2. **Elementos de la URS:**\n   - Descripci\u00f3n del software y su versi\u00f3n.\n   - Requisitos de hardware y sistema operativo.\n   - Descripci\u00f3n de funciones y atributos de datos.\n   - Dise\u00f1o de base de datos y especificaciones de macros y f\u00f3rmulas.\n   - Requisitos de trazabilidad de datos y protecci\u00f3n de la aplicaci\u00f3n.\n\n3. **Control de Cambios y Trazabilidad:**\n   - Necesidad de un control de versiones para la URS.\n   - Importancia de documentar y comunicar cambios en los requisitos.\n\n**Entidades Clave:**\n- **OMCL (Organizaci\u00f3n de Laboratorios de Control de Medicamentos):** Define los requisitos para la URS.\n- **Sistemas Computarizados:** Incluyen software (como Excel, Access, Oracle) y hardware relacionado.\n- **Requisitos de Seguridad de la Informaci\u00f3n:** Aspectos que deben ser considerados en la URS para proteger datos sensibles.\n\nEste resumen destaca la estructura y los elementos esenciales que deben ser considerados al validar sistemas computarizados complejos, enfatizando la importancia de la URS y la trazabilidad en la gesti\u00f3n de cambios.", "excerpt_keywords": "Keywords: Installation Qualification, Operational Qualification, Computerized Systems, Validation, System Integration"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "23f027ad-6c4c-49a4-984f-811be58da955", "node_type": "4", "metadata": {"page_label": "3", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "Colombia/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "image_path": "", "parsed_text_markdown": "# 3. INSTALLATION QUALIFICATION (IQ)\n\nThe correct installation of the system in the IT environment with defined hardware and operating software shall be documented and tested. Detailed installation procedures should be available and carried out by well-trained personnel only.\n\nChecklists with predefined installation steps and acceptance criteria can ensure the correct installation of the system and the traceable qualification of the installation.\n\nIn most cases, the computerised system is connected to a computer network with interfaces to other software (other applications) and hardware (computer equipment or laboratory equipment). It must be ensured that the system is correctly integrated and that all components are operative.\n\nThe IQ typically includes:\n\na) A check of the required system resources both of the server and client, when applicable (e.g. supported operating system, database engine, performance of the processor, free space on the hard disk, memory, access rights for installations);\n\nb) Documentation of the components of the system (as a minimum, a description of the components and version of the relevant components with date of implementation);\n\nc) List of users or user groups with access to the application, including type of access;\n\nd) Integration test and/or communication test for the interfaces to other systems/equipment.\n\nOften the installation is supported by the supplier and the internal IT unit.\n\n# 4. OPERATIONAL QUALIFICATION (OQ)\n\nThe proper functioning of the software shall be checked by testing the key functions, e.g. calibration and quantification (internal standards, external standards), peak identification, and calculation of system suitability parameters.\n\nIdeally, a raw data set can be used for which the results are known. These raw data sets are often provided by the supplier of the software, are processed by the software and the results are then compared to the expected values.\n\nIf no such data sets are available, example raw data sets can be acquired by running typical samples. The results of the processed raw data sets should be verified by recalculating the key parameters (e.g. calibration curves from peak areas of standards) using standard (e.g., spreadsheet) software.\n\nRaw data from the testing of functions affecting the measurement result and its associated measurement uncertainty (input and output data, screenshots) shall be documented within the qualification report.\n\nOperational qualification should be repeated in a risk-based approach after installation of new software modules, new software versions, new service packs, patch updates, or after major changes in the software structure of the computer (e.g. new anti-virus software). A similar approach should be taken for every change in hardware platform or system upgrades.", "parsed_text": "", "document_title": "PA-PH-OMCL (08) 88 R5 Annex 2 - Validation of Complex Computerised Systems"}, "hash": "05dc8cc5659cd4a8a33cc5c3f8ee8817cb93f193ab6d9ab825bc8d54c5e9a644", "class_name": "RelatedNodeInfo"}}, "metadata_template": "{key}: {value}", "metadata_separator": "\n", "text": "# 3. INSTALLATION QUALIFICATION (IQ)\n\nThe correct installation of the system in the IT environment with defined hardware and operating software shall be documented and tested. Detailed installation procedures should be available and carried out by well-trained personnel only.\n\nChecklists with predefined installation steps and acceptance criteria can ensure the correct installation of the system and the traceable qualification of the installation.\n\nIn most cases, the computerised system is connected to a computer network with interfaces to other software (other applications) and hardware (computer equipment or laboratory equipment). It must be ensured that the system is correctly integrated and that all components are operative.\n\nThe IQ typically includes:\n\na) A check of the required system resources both of the server and client, when applicable (e.g. supported operating system, database engine, performance of the processor, free space on the hard disk, memory, access rights for installations);\n\nb) Documentation of the components of the system (as a minimum, a description of the components and version of the relevant components with date of implementation);\n\nc) List of users or user groups with access to the application, including type of access;\n\nd) Integration test and/or communication test for the interfaces to other systems/equipment.\n\nOften the installation is supported by the supplier and the internal IT unit.\n\n# 4. OPERATIONAL QUALIFICATION (OQ)\n\nThe proper functioning of the software shall be checked by testing the key functions, e.g. calibration and quantification (internal standards, external standards), peak identification, and calculation of system suitability parameters.\n\nIdeally, a raw data set can be used for which the results are known. These raw data sets are often provided by the supplier of the software, are processed by the software and the results are then compared to the expected values.\n\nIf no such data sets are available, example raw data sets can be acquired by running typical samples. The results of the processed raw data sets should be verified by recalculating the key parameters (e.g. calibration curves from peak areas of standards) using standard (e.g., spreadsheet) software.\n\nRaw data from the testing of functions affecting the measurement result and its associated measurement uncertainty (input and output data, screenshots) shall be documented within the qualification report.\n\nOperational qualification should be repeated in a risk-based approach after installation of new software modules, new software versions, new service packs, patch updates, or after major changes in the software structure of the computer (e.g. new anti-virus software). A similar approach should be taken for every change in hardware platform or system upgrades.", "mimetype": "text/plain", "start_char_idx": 0, "end_char_idx": 2811, "metadata_seperator": "\n", "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "class_name": "TextNode"}, "__type__": "1"}, "cf6692e8-0469-403d-87d5-7d027815de23": {"__data__": {"id_": "cf6692e8-0469-403d-87d5-7d027815de23", "embedding": null, "metadata": {"page_label": "4", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "Colombia/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "image_path": "", "parsed_text_markdown": "## 5. PERFORMANCE QUALIFICATION (PQ)\n\nThe aim of the performance qualification is to demonstrate that a computerised system is suitable for its intended purpose in the user\u2019s own environment as defined in the URS. The user requirements shall be tested in the PQ phase to cover the overall business use of the system in the daily routine.\n\nThe PQ typically includes:\n\na) Tests of functions (e.g. with a data set to ensure each feature of the application is tested);\nb) Negative or limit test (e.g. input of values outside the specified range);\nc) Test of alarm displays, if applicable (e.g. display of an OOS result);\nd) Unauthorised input of data and access to the application;\ne) Tests of aberrant data (e.g. input of data in the wrong data format);\nf) Backup system and restore test;\ng) Verification of data migration, if applicable;\nh) Conformity with requirements of data protection, if applicable;\ni) Black box test as acceptance testing of the whole system.\n\nEach test scenario should be traceable to the URS being tested and should describe the expected results, the acceptance criteria and the observed results. Each deviation from the expected results and acceptance criteria must be discussed in the test report. A deviation can either lead to a change in the system and the test being run again or be accepted and documented with an update of the corresponding URS. Raw data from the testing (input and output data, screenshots) shall be documented within the qualification report.\n\n## 6. RELEASE FOR USE\n\nA summary of all the test findings shall be presented in a validation report, including any deviation and the corrective actions taken. When all deviations are resolved or accepted, a formal release of the system is issued.\n\n## 7. ARCHIVING\n\nAll documentation related to specification and qualification of complex computerised systems must be retained as long as the application is in use, plus a defined retention period covering all applicable archiving obligations. This obligation can be covered by a contract with the software provider.", "parsed_text": "", "document_title": "PA-PH-OMCL (08) 88 R5 Annex 2 - Validation of Complex Computerised Systems", "questions_this_excerpt_can_answer": "Aqu\u00ed tienes tres preguntas espec\u00edficas que se pueden responder con el contexto proporcionado, as\u00ed como un resumen de nivel superior que puede ayudar a formular preguntas m\u00e1s relevantes:\n\n### Resumen de Nivel Superior\nEl documento se centra en la validaci\u00f3n de sistemas inform\u00e1ticos complejos, destacando la importancia de la calificaci\u00f3n de rendimiento (PQ) para asegurar que un sistema cumple con los requisitos del usuario en su entorno espec\u00edfico. Se describen los tipos de pruebas que deben realizarse durante la PQ, la necesidad de documentar los resultados y las desviaciones, y los procedimientos para la liberaci\u00f3n y archivo de la documentaci\u00f3n relacionada con la calificaci\u00f3n del sistema.\n\n### Preguntas Espec\u00edficas\n\n1. **\u00bfQu\u00e9 tipo de pruebas se consideran esenciales durante la fase de calificaci\u00f3n de rendimiento (PQ) para un sistema inform\u00e1tico?**\n   - Respuesta: Las pruebas esenciales incluyen pruebas de funciones, pruebas negativas o de l\u00edmite, pruebas de alarmas, pruebas de acceso no autorizado, pruebas de datos aberrantes, pruebas de respaldo y restauraci\u00f3n, verificaci\u00f3n de migraci\u00f3n de datos, conformidad con requisitos de protecci\u00f3n de datos y pruebas de caja negra.\n\n2. **\u00bfC\u00f3mo se debe manejar una desviaci\u00f3n de los resultados esperados durante la calificaci\u00f3n de rendimiento?**\n   - Respuesta: Cada desviaci\u00f3n debe ser discutida en el informe de prueba. Puede llevar a un cambio en el sistema y la repetici\u00f3n de la prueba, o puede ser aceptada y documentada con una actualizaci\u00f3n del correspondiente documento de requisitos del usuario (URS).\n\n3. **\u00bfCu\u00e1l es la obligaci\u00f3n de archivo relacionada con la documentaci\u00f3n de sistemas inform\u00e1ticos complejos seg\u00fan el documento?**\n   - Respuesta: Toda la documentaci\u00f3n relacionada con la especificaci\u00f3n y calificaci\u00f3n de sistemas inform\u00e1ticos complejos debe ser retenida mientras la aplicaci\u00f3n est\u00e9 en uso, m\u00e1s un per\u00edodo de retenci\u00f3n definido que cubra todas las obligaciones de archivo aplicables. Esta obligaci\u00f3n puede ser cubierta por un contrato con el proveedor de software.", "prev_section_summary": "### Temas Clave\n\n1. **Calificaci\u00f3n de Instalaci\u00f3n (IQ)**:\n   - Importancia de la documentaci\u00f3n y pruebas para asegurar la correcta instalaci\u00f3n del sistema.\n   - Verificaci\u00f3n de recursos del sistema (hardware y software).\n   - Documentaci\u00f3n de componentes y versiones.\n   - Listado de usuarios y sus tipos de acceso.\n   - Pruebas de integraci\u00f3n y comunicaci\u00f3n con otros sistemas.\n\n2. **Calificaci\u00f3n Operativa (OQ)**:\n   - Comprobaci\u00f3n del funcionamiento adecuado del software mediante pruebas de funciones clave.\n   - Uso de conjuntos de datos conocidos para validar resultados.\n   - Documentaci\u00f3n de datos de entrada y salida, as\u00ed como capturas de pantalla.\n   - Repetici\u00f3n de la OQ tras cambios significativos en software o hardware, utilizando un enfoque basado en riesgos.\n\n### Entidades\n\n- **Sistemas Inform\u00e1ticos**: Sistemas que requieren validaci\u00f3n para asegurar su correcto funcionamiento en entornos IT.\n- **Hardware y Software**: Componentes necesarios para la instalaci\u00f3n y operaci\u00f3n del sistema.\n- **Usuarios**: Personas o grupos con acceso al sistema, cuya gesti\u00f3n es parte de la documentaci\u00f3n de la IQ.\n- **Proveedores**: Entidades que pueden apoyar en la instalaci\u00f3n y validaci\u00f3n del sistema.\n- **Datos de Prueba**: Conjuntos de datos utilizados para validar el funcionamiento del software durante la OQ.\n\n### Resumen\n\nLa secci\u00f3n aborda la validaci\u00f3n de sistemas inform\u00e1ticos complejos a trav\u00e9s de dos etapas fundamentales: la Calificaci\u00f3n de Instalaci\u00f3n (IQ) y la Calificaci\u00f3n Operativa (OQ). La IQ se centra en asegurar que el sistema est\u00e9 correctamente instalado y documentado, verificando recursos, componentes y accesos. La OQ, por su parte, se enfoca en comprobar el correcto funcionamiento del software mediante pruebas de funciones clave y la comparaci\u00f3n de resultados con valores esperados, adem\u00e1s de la necesidad de repetir estas pruebas tras cambios significativos en el sistema.", "excerpt_keywords": "Keywords: performance qualification, validation report, user requirements specification, data protection, archiving obligations"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "24cdac13-0673-4610-abdb-0a92a6078823", "node_type": "4", "metadata": {"page_label": "4", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "Colombia/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "image_path": "", "parsed_text_markdown": "## 5. PERFORMANCE QUALIFICATION (PQ)\n\nThe aim of the performance qualification is to demonstrate that a computerised system is suitable for its intended purpose in the user\u2019s own environment as defined in the URS. The user requirements shall be tested in the PQ phase to cover the overall business use of the system in the daily routine.\n\nThe PQ typically includes:\n\na) Tests of functions (e.g. with a data set to ensure each feature of the application is tested);\nb) Negative or limit test (e.g. input of values outside the specified range);\nc) Test of alarm displays, if applicable (e.g. display of an OOS result);\nd) Unauthorised input of data and access to the application;\ne) Tests of aberrant data (e.g. input of data in the wrong data format);\nf) Backup system and restore test;\ng) Verification of data migration, if applicable;\nh) Conformity with requirements of data protection, if applicable;\ni) Black box test as acceptance testing of the whole system.\n\nEach test scenario should be traceable to the URS being tested and should describe the expected results, the acceptance criteria and the observed results. Each deviation from the expected results and acceptance criteria must be discussed in the test report. A deviation can either lead to a change in the system and the test being run again or be accepted and documented with an update of the corresponding URS. Raw data from the testing (input and output data, screenshots) shall be documented within the qualification report.\n\n## 6. RELEASE FOR USE\n\nA summary of all the test findings shall be presented in a validation report, including any deviation and the corrective actions taken. When all deviations are resolved or accepted, a formal release of the system is issued.\n\n## 7. ARCHIVING\n\nAll documentation related to specification and qualification of complex computerised systems must be retained as long as the application is in use, plus a defined retention period covering all applicable archiving obligations. This obligation can be covered by a contract with the software provider.", "parsed_text": "", "document_title": "PA-PH-OMCL (08) 88 R5 Annex 2 - Validation of Complex Computerised Systems"}, "hash": "a77e1f82624f0c1b356e696045320059a4918ade2097ef31319b965a87f4216c", "class_name": "RelatedNodeInfo"}}, "metadata_template": "{key}: {value}", "metadata_separator": "\n", "text": "## 5. PERFORMANCE QUALIFICATION (PQ)\n\nThe aim of the performance qualification is to demonstrate that a computerised system is suitable for its intended purpose in the user\u2019s own environment as defined in the URS. The user requirements shall be tested in the PQ phase to cover the overall business use of the system in the daily routine.\n\nThe PQ typically includes:\n\na) Tests of functions (e.g. with a data set to ensure each feature of the application is tested);\nb) Negative or limit test (e.g. input of values outside the specified range);\nc) Test of alarm displays, if applicable (e.g. display of an OOS result);\nd) Unauthorised input of data and access to the application;\ne) Tests of aberrant data (e.g. input of data in the wrong data format);\nf) Backup system and restore test;\ng) Verification of data migration, if applicable;\nh) Conformity with requirements of data protection, if applicable;\ni) Black box test as acceptance testing of the whole system.\n\nEach test scenario should be traceable to the URS being tested and should describe the expected results, the acceptance criteria and the observed results. Each deviation from the expected results and acceptance criteria must be discussed in the test report. A deviation can either lead to a change in the system and the test being run again or be accepted and documented with an update of the corresponding URS. Raw data from the testing (input and output data, screenshots) shall be documented within the qualification report.\n\n## 6. RELEASE FOR USE\n\nA summary of all the test findings shall be presented in a validation report, including any deviation and the corrective actions taken. When all deviations are resolved or accepted, a formal release of the system is issued.\n\n## 7. ARCHIVING\n\nAll documentation related to specification and qualification of complex computerised systems must be retained as long as the application is in use, plus a defined retention period covering all applicable archiving obligations. This obligation can be covered by a contract with the software provider.", "mimetype": "text/plain", "start_char_idx": 0, "end_char_idx": 2058, "metadata_seperator": "\n", "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "class_name": "TextNode"}, "__type__": "1"}}, "docstore/metadata": {"d5ce33e2-6e3a-42b9-a877-ee52f57b1cd1": {"doc_hash": "448901c5e698ba220dc31942da6e18b8ed4d071dda8eea49a4cbeb2df351a07c", "ref_doc_id": "061b05f4-5cde-4fbe-ba22-cbb49f5b11af"}, "9d55f4a2-9d3f-462d-b909-1f337509e18b": {"doc_hash": "e329f5d1f34c1adfee09036bf24a2e7a1f0de6017e300648e62eecfa58bd733e", "ref_doc_id": "29bf79f7-7153-4187-bbc4-2a6c440e5ae0"}, "ea6d1619-4507-4b1c-9937-17b1edc6017c": {"doc_hash": "b1b57a3b626fac0846e53b92dbd6f8f86ff9bcfe5587a98f14b81f9720218ff9", "ref_doc_id": "23f027ad-6c4c-49a4-984f-811be58da955"}, "cf6692e8-0469-403d-87d5-7d027815de23": {"doc_hash": "b1249cb867db5bd1b6f3f5d7019a23c6192447e15ed0005c067671af0e55163f", "ref_doc_id": "24cdac13-0673-4610-abdb-0a92a6078823"}}, "docstore/ref_doc_info": {"061b05f4-5cde-4fbe-ba22-cbb49f5b11af": {"node_ids": ["d5ce33e2-6e3a-42b9-a877-ee52f57b1cd1"], "metadata": {"page_label": "1", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "Colombia/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "image_path": "", "parsed_text_markdown": "# General European OMCL Network (GEON)\n## QUALITY MANAGEMENT DOCUMENT\n\n**PA/PH/OMCL (08) 88 R5**\n\n**VALIDATION OF COMPUTERISED SYSTEMS**\n**ANNEX 2 \u2013 VALIDATION OF COMPLEX COMPUTERISED SYSTEMS**\n\n|                                                           |                                                                                                                                                                                           |\n| --------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| **Full document title and reference**                     | Validation of Computerised Systems Annex 2 \u2013 Validation of Complex Computerised Systems PA/PH/OMCL (08) 88 R5                                                                             |\n| **Document type**                                         | Guideline                                                                                                                                                                                 |\n| **Legislative basis**                                     | -                                                                                                                                                                                         |\n| **Date of first adoption**                                | May 2009                                                                                                                                                                                  |\n| **Date of original entry into force**                     | July 2009                                                                                                                                                                                 |\n| **Date of entry into force of revised document**          | August 2018                                                                                                                                                                               |\n| **Previous titles/other references / last valid version** | Validation of Computerised Systems Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN) PA/PH/OMCL (08) 88 R |\n| **Custodian Organisation**                                | The present document was elaborated by the OMCL Network / EDQM of the Council of Europe                                                                                                   |\n| **Concerned Network**                                     | GEON                                                                                                                                                                                      |\n", "parsed_text": "", "document_title": "PA-PH-OMCL (08) 88 R5 Annex 2 - Validation of Complex Computerised Systems", "questions_this_excerpt_can_answer": "Aqu\u00ed tienes tres preguntas que se pueden formular a partir del contexto proporcionado, junto con sus respuestas espec\u00edficas:\n\n1. **\u00bfCu\u00e1l es la fecha de entrada en vigor del documento revisado sobre la validaci\u00f3n de sistemas computarizados?**\n   - **Respuesta:** La fecha de entrada en vigor del documento revisado es agosto de 2018.\n\n2. **\u00bfQu\u00e9 organizaci\u00f3n es responsable de la elaboraci\u00f3n del documento PA/PH/OMCL (08) 88 R5?**\n   - **Respuesta:** El documento fue elaborado por la Red OMCL / EDQM del Consejo de Europa.\n\n3. **\u00bfCu\u00e1l es el t\u00edtulo anterior del documento que se menciona en el contexto?**\n   - **Respuesta:** El t\u00edtulo anterior del documento es \"Validation of Computerised Systems Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN) PA/PH/OMCL (08) 88 R\".\n\n### Resumen de nivel superior del contexto:\nEl documento PA/PH/OMCL (08) 88 R5 es una gu\u00eda sobre la validaci\u00f3n de sistemas computarizados, espec\u00edficamente enfoc\u00e1ndose en sistemas complejos. Fue adoptado por primera vez en mayo de 2009 y ha sido revisado, con la versi\u00f3n actual en vigor desde agosto de 2018. La gu\u00eda es parte de los esfuerzos de la Red OMCL y est\u00e1 destinada a asegurar la calidad en la gesti\u00f3n de sistemas computarizados en el \u00e1mbito de la salud y la investigaci\u00f3n.", "excerpt_keywords": "Keywords: validation, computerized systems, OMCL Network, guideline, quality management"}}, "29bf79f7-7153-4187-bbc4-2a6c440e5ae0": {"node_ids": ["9d55f4a2-9d3f-462d-b909-1f337509e18b"], "metadata": {"page_label": "2", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "Colombia/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "image_path": "", "parsed_text_markdown": "# ANNEX 2 OF THE OMCL NETWORK GUIDELINE\n\u201cVALIDATION OF COMPUTERISED SYSTEMS\u201d\n\n## VALIDATION OF COMPLEX COMPUTERISED SYSTEMS\n\n*Note: Mandatory requirements in this guideline and its annexes are defined using the terms \u00abshall\u00bb or \u00abmust\u00bb. The use of \u00abshould\u00bb indicates a recommendation. For these parts of the text other appropriately justified approaches are acceptable. The term \u00abcan\u00bb indicates a possibility or an example with non-binding character.*\n\n### 1. INTRODUCTION\n\nThis is the 2nd Annex of the core document \u201cValidation of Computerised Systems\u201d, and it should be used in combination with the latter when planning, performing and documenting the validation steps of complex computerised systems. Excel spreadsheet validation is described in the 1st Annex of the core document and not subjected here.\n\n### 2. USER REQUIREMENTS SPECIFICATIONS (URS)\n\nThe selection and purchase of new software and the associated computer and laboratory equipment should follow a conscious decision-making process based on the requirements for the intended use of the computerised system. A User Requirements Specification (URS) should describe the functional and technical requirements of the computerised system, as defined by the OMCL, in terms of both software and hardware. It should also cover the aspects of information security and data integrity.\n\nSome of the items that can be included are:\n\na) Description of the software used (e.g. Excel, Access, Oracle), including version;\nb) Requirements on hardware components and operating system;\nc) Description of functions;\nd) Description of the attributes of data;\ne) Terminology (e.g. important especially for the consistent description of input masks / fields);\nf) Database design, including masks and fields as well as a map of the data relationships;\ng) Specifications of macros, formulas and control commands;\nh) Specifications of the data inputs (e.g. format, decimal places, units);\ni) Specification of the mandatory fields for data;\nj) Specifications of the protection of masks, working sheets or the whole application;\nk) Planning of the data migration, if applicable;\nl) Specifications for traceability of data entry and changes (audit trail) of interfaces to other system components, if applicable.\n\nThe URS shall be released by a responsible person. Changes to the requirements are possible but the changes should be traceable and the URS document should be version controlled or an equivalent system established in order to ensure traceability. New or changed requirements should be communicated to all persons involved.", "parsed_text": "", "document_title": "PA-PH-OMCL (08) 88 R5 Annex 2 - Validation of Complex Computerised Systems", "questions_this_excerpt_can_answer": "Aqu\u00ed tienes tres preguntas espec\u00edficas que se pueden responder con el contexto proporcionado, as\u00ed como un resumen de nivel superior:\n\n### Resumen de Nivel Superior\nEl documento es el Anexo 2 de la gu\u00eda de la Red OMCL sobre la validaci\u00f3n de sistemas computarizados complejos. Se centra en la importancia de las Especificaciones de Requisitos del Usuario (URS) para la selecci\u00f3n y compra de software y equipos relacionados. Se enfatiza que la URS debe detallar los requisitos funcionales y t\u00e9cnicos, as\u00ed como aspectos de seguridad de la informaci\u00f3n e integridad de los datos. Adem\u00e1s, se menciona la necesidad de un control de versiones y trazabilidad en los cambios de requisitos.\n\n### Preguntas Espec\u00edficas\n\n1. **\u00bfQu\u00e9 elementos espec\u00edficos deben incluirse en una Especificaci\u00f3n de Requisitos del Usuario (URS) para un sistema computarizado complejo?**\n   - La URS debe incluir elementos como la descripci\u00f3n del software y su versi\u00f3n, requisitos de hardware y sistema operativo, descripci\u00f3n de funciones, atributos de datos, dise\u00f1o de base de datos, especificaciones de macros y f\u00f3rmulas, y requisitos de trazabilidad de datos, entre otros.\n\n2. **\u00bfCu\u00e1l es la importancia de la trazabilidad en la gesti\u00f3n de cambios de la URS?**\n   - La trazabilidad es crucial para asegurar que cualquier cambio en los requisitos sea documentado y comunicado a todas las partes involucradas. Esto ayuda a mantener la integridad del proceso de validaci\u00f3n y asegura que todos los cambios sean controlados y justificados.\n\n3. **\u00bfQu\u00e9 papel juega la seguridad de la informaci\u00f3n en la URS seg\u00fan el documento?**\n   - La URS debe abordar aspectos de seguridad de la informaci\u00f3n y de integridad de los datos, asegurando que el sistema computarizado cumpla con los est\u00e1ndares necesarios para proteger la informaci\u00f3n sensible y garantizar que los datos sean precisos y confiables.", "prev_section_summary": "El documento PA/PH/OMCL (08) 88 R5 es una gu\u00eda que aborda la validaci\u00f3n de sistemas computarizados, con un enfoque particular en sistemas complejos. A continuaci\u00f3n se presentan los temas clave y entidades mencionadas en la secci\u00f3n:\n\n### Temas Clave:\n1. **Validaci\u00f3n de Sistemas Computarizados**: El documento proporciona directrices sobre c\u00f3mo validar sistemas computarizados en el contexto de la salud y la investigaci\u00f3n.\n2. **Revisi\u00f3n y Actualizaci\u00f3n**: Se menciona la fecha de primera adopci\u00f3n (mayo de 2009) y las fechas de entrada en vigor de la versi\u00f3n original (julio de 2009) y la versi\u00f3n revisada (agosto de 2018).\n3. **Documentaci\u00f3n y Referencias**: Incluye informaci\u00f3n sobre t\u00edtulos anteriores y referencias relacionadas con la validaci\u00f3n de bases de datos, sistemas de gesti\u00f3n de informaci\u00f3n de laboratorio y cuadernos de laboratorio electr\u00f3nicos.\n\n### Entidades:\n- **Organizaci\u00f3n Custodia**: OMCL Network / EDQM del Consejo de Europa, responsable de la elaboraci\u00f3n del documento.\n- **Red Concernida**: General European OMCL Network (GEON), que se ocupa de la calidad en la gesti\u00f3n de sistemas computarizados.\n\nEste resumen destaca la importancia del documento en la regulaci\u00f3n y aseguramiento de la calidad de los sistemas computarizados en el \u00e1mbito de la salud, as\u00ed como su evoluci\u00f3n a lo largo del tiempo.", "excerpt_keywords": "Keywords: validation, computerized systems, user requirements specification, data integrity, information security"}}, "23f027ad-6c4c-49a4-984f-811be58da955": {"node_ids": ["ea6d1619-4507-4b1c-9937-17b1edc6017c"], "metadata": {"page_label": "3", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "Colombia/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "image_path": "", "parsed_text_markdown": "# 3. INSTALLATION QUALIFICATION (IQ)\n\nThe correct installation of the system in the IT environment with defined hardware and operating software shall be documented and tested. Detailed installation procedures should be available and carried out by well-trained personnel only.\n\nChecklists with predefined installation steps and acceptance criteria can ensure the correct installation of the system and the traceable qualification of the installation.\n\nIn most cases, the computerised system is connected to a computer network with interfaces to other software (other applications) and hardware (computer equipment or laboratory equipment). It must be ensured that the system is correctly integrated and that all components are operative.\n\nThe IQ typically includes:\n\na) A check of the required system resources both of the server and client, when applicable (e.g. supported operating system, database engine, performance of the processor, free space on the hard disk, memory, access rights for installations);\n\nb) Documentation of the components of the system (as a minimum, a description of the components and version of the relevant components with date of implementation);\n\nc) List of users or user groups with access to the application, including type of access;\n\nd) Integration test and/or communication test for the interfaces to other systems/equipment.\n\nOften the installation is supported by the supplier and the internal IT unit.\n\n# 4. OPERATIONAL QUALIFICATION (OQ)\n\nThe proper functioning of the software shall be checked by testing the key functions, e.g. calibration and quantification (internal standards, external standards), peak identification, and calculation of system suitability parameters.\n\nIdeally, a raw data set can be used for which the results are known. These raw data sets are often provided by the supplier of the software, are processed by the software and the results are then compared to the expected values.\n\nIf no such data sets are available, example raw data sets can be acquired by running typical samples. The results of the processed raw data sets should be verified by recalculating the key parameters (e.g. calibration curves from peak areas of standards) using standard (e.g., spreadsheet) software.\n\nRaw data from the testing of functions affecting the measurement result and its associated measurement uncertainty (input and output data, screenshots) shall be documented within the qualification report.\n\nOperational qualification should be repeated in a risk-based approach after installation of new software modules, new software versions, new service packs, patch updates, or after major changes in the software structure of the computer (e.g. new anti-virus software). A similar approach should be taken for every change in hardware platform or system upgrades.", "parsed_text": "", "document_title": "PA-PH-OMCL (08) 88 R5 Annex 2 - Validation of Complex Computerised Systems", "questions_this_excerpt_can_answer": "Aqu\u00ed tienes tres preguntas espec\u00edficas que se pueden responder con el contexto proporcionado, junto con un resumen de nivel superior:\n\n### Resumen de Nivel Superior\nEl documento aborda la validaci\u00f3n de sistemas inform\u00e1ticos complejos, centr\u00e1ndose en dos etapas clave: la Calificaci\u00f3n de Instalaci\u00f3n (IQ) y la Calificaci\u00f3n Operativa (OQ). La IQ se enfoca en asegurar que el sistema est\u00e9 correctamente instalado y documentado, incluyendo la verificaci\u00f3n de recursos del sistema, documentaci\u00f3n de componentes y pruebas de integraci\u00f3n. Por otro lado, la OQ se centra en comprobar el funcionamiento adecuado del software mediante pruebas de funciones clave y la comparaci\u00f3n de resultados con valores esperados, adem\u00e1s de la necesidad de repetir estas pruebas tras cambios significativos en el software o hardware.\n\n### Preguntas Espec\u00edficas\n\n1. **\u00bfQu\u00e9 tipo de documentaci\u00f3n se requiere para la Calificaci\u00f3n de Instalaci\u00f3n (IQ) y por qu\u00e9 es importante?**\n   - La IQ requiere documentaci\u00f3n que incluya una descripci\u00f3n de los componentes del sistema, versiones relevantes y fechas de implementaci\u00f3n, as\u00ed como una lista de usuarios con acceso y sus tipos de acceso. Esta documentaci\u00f3n es crucial para garantizar que la instalaci\u00f3n se realice de manera correcta y que se pueda rastrear la calificaci\u00f3n de la instalaci\u00f3n.\n\n2. **\u00bfCu\u00e1les son los pasos recomendados para llevar a cabo la Calificaci\u00f3n Operativa (OQ) y qu\u00e9 tipo de datos se deben documentar?**\n   - Para la OQ, se deben realizar pruebas de funciones clave del software, utilizando conjuntos de datos en los que se conocen los resultados esperados. Los datos de entrada y salida, as\u00ed como capturas de pantalla, deben ser documentados en el informe de calificaci\u00f3n para asegurar la trazabilidad y la verificaci\u00f3n de los resultados.\n\n3. **\u00bfQu\u00e9 condiciones pueden requerir la repetici\u00f3n de la Calificaci\u00f3n Operativa (OQ) y por qu\u00e9 es relevante un enfoque basado en riesgos?**\n   - La OQ debe repetirse tras la instalaci\u00f3n de nuevos m\u00f3dulos de software, actualizaciones de versiones, o cambios significativos en la estructura del software o hardware. Un enfoque basado en riesgos es relevante porque permite priorizar las pruebas en funci\u00f3n de la magnitud del cambio y su posible impacto en el funcionamiento del sistema, asegurando as\u00ed la integridad y confiabilidad del software.", "prev_section_summary": "### Resumen de Temas Clave y Entidades\n\n**Tema Principal:**\n- Validaci\u00f3n de Sistemas Computarizados Complejos: El documento se centra en la validaci\u00f3n de sistemas computarizados complejos, proporcionando directrices sobre c\u00f3mo llevar a cabo este proceso de manera efectiva.\n\n**Subtemas:**\n1. **Especificaciones de Requisitos del Usuario (URS):**\n   - Importancia de la URS en la selecci\u00f3n y compra de software y equipos.\n   - Detalle de requisitos funcionales y t\u00e9cnicos, as\u00ed como aspectos de seguridad de la informaci\u00f3n e integridad de los datos.\n\n2. **Elementos de la URS:**\n   - Descripci\u00f3n del software y su versi\u00f3n.\n   - Requisitos de hardware y sistema operativo.\n   - Descripci\u00f3n de funciones y atributos de datos.\n   - Dise\u00f1o de base de datos y especificaciones de macros y f\u00f3rmulas.\n   - Requisitos de trazabilidad de datos y protecci\u00f3n de la aplicaci\u00f3n.\n\n3. **Control de Cambios y Trazabilidad:**\n   - Necesidad de un control de versiones para la URS.\n   - Importancia de documentar y comunicar cambios en los requisitos.\n\n**Entidades Clave:**\n- **OMCL (Organizaci\u00f3n de Laboratorios de Control de Medicamentos):** Define los requisitos para la URS.\n- **Sistemas Computarizados:** Incluyen software (como Excel, Access, Oracle) y hardware relacionado.\n- **Requisitos de Seguridad de la Informaci\u00f3n:** Aspectos que deben ser considerados en la URS para proteger datos sensibles.\n\nEste resumen destaca la estructura y los elementos esenciales que deben ser considerados al validar sistemas computarizados complejos, enfatizando la importancia de la URS y la trazabilidad en la gesti\u00f3n de cambios.", "excerpt_keywords": "Keywords: Installation Qualification, Operational Qualification, Computerized Systems, Validation, System Integration"}}, "24cdac13-0673-4610-abdb-0a92a6078823": {"node_ids": ["cf6692e8-0469-403d-87d5-7d027815de23"], "metadata": {"page_label": "4", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "Colombia/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "image_path": "", "parsed_text_markdown": "## 5. PERFORMANCE QUALIFICATION (PQ)\n\nThe aim of the performance qualification is to demonstrate that a computerised system is suitable for its intended purpose in the user\u2019s own environment as defined in the URS. The user requirements shall be tested in the PQ phase to cover the overall business use of the system in the daily routine.\n\nThe PQ typically includes:\n\na) Tests of functions (e.g. with a data set to ensure each feature of the application is tested);\nb) Negative or limit test (e.g. input of values outside the specified range);\nc) Test of alarm displays, if applicable (e.g. display of an OOS result);\nd) Unauthorised input of data and access to the application;\ne) Tests of aberrant data (e.g. input of data in the wrong data format);\nf) Backup system and restore test;\ng) Verification of data migration, if applicable;\nh) Conformity with requirements of data protection, if applicable;\ni) Black box test as acceptance testing of the whole system.\n\nEach test scenario should be traceable to the URS being tested and should describe the expected results, the acceptance criteria and the observed results. Each deviation from the expected results and acceptance criteria must be discussed in the test report. A deviation can either lead to a change in the system and the test being run again or be accepted and documented with an update of the corresponding URS. Raw data from the testing (input and output data, screenshots) shall be documented within the qualification report.\n\n## 6. RELEASE FOR USE\n\nA summary of all the test findings shall be presented in a validation report, including any deviation and the corrective actions taken. When all deviations are resolved or accepted, a formal release of the system is issued.\n\n## 7. ARCHIVING\n\nAll documentation related to specification and qualification of complex computerised systems must be retained as long as the application is in use, plus a defined retention period covering all applicable archiving obligations. This obligation can be covered by a contract with the software provider.", "parsed_text": "", "document_title": "PA-PH-OMCL (08) 88 R5 Annex 2 - Validation of Complex Computerised Systems", "questions_this_excerpt_can_answer": "Aqu\u00ed tienes tres preguntas espec\u00edficas que se pueden responder con el contexto proporcionado, as\u00ed como un resumen de nivel superior que puede ayudar a formular preguntas m\u00e1s relevantes:\n\n### Resumen de Nivel Superior\nEl documento se centra en la validaci\u00f3n de sistemas inform\u00e1ticos complejos, destacando la importancia de la calificaci\u00f3n de rendimiento (PQ) para asegurar que un sistema cumple con los requisitos del usuario en su entorno espec\u00edfico. Se describen los tipos de pruebas que deben realizarse durante la PQ, la necesidad de documentar los resultados y las desviaciones, y los procedimientos para la liberaci\u00f3n y archivo de la documentaci\u00f3n relacionada con la calificaci\u00f3n del sistema.\n\n### Preguntas Espec\u00edficas\n\n1. **\u00bfQu\u00e9 tipo de pruebas se consideran esenciales durante la fase de calificaci\u00f3n de rendimiento (PQ) para un sistema inform\u00e1tico?**\n   - Respuesta: Las pruebas esenciales incluyen pruebas de funciones, pruebas negativas o de l\u00edmite, pruebas de alarmas, pruebas de acceso no autorizado, pruebas de datos aberrantes, pruebas de respaldo y restauraci\u00f3n, verificaci\u00f3n de migraci\u00f3n de datos, conformidad con requisitos de protecci\u00f3n de datos y pruebas de caja negra.\n\n2. **\u00bfC\u00f3mo se debe manejar una desviaci\u00f3n de los resultados esperados durante la calificaci\u00f3n de rendimiento?**\n   - Respuesta: Cada desviaci\u00f3n debe ser discutida en el informe de prueba. Puede llevar a un cambio en el sistema y la repetici\u00f3n de la prueba, o puede ser aceptada y documentada con una actualizaci\u00f3n del correspondiente documento de requisitos del usuario (URS).\n\n3. **\u00bfCu\u00e1l es la obligaci\u00f3n de archivo relacionada con la documentaci\u00f3n de sistemas inform\u00e1ticos complejos seg\u00fan el documento?**\n   - Respuesta: Toda la documentaci\u00f3n relacionada con la especificaci\u00f3n y calificaci\u00f3n de sistemas inform\u00e1ticos complejos debe ser retenida mientras la aplicaci\u00f3n est\u00e9 en uso, m\u00e1s un per\u00edodo de retenci\u00f3n definido que cubra todas las obligaciones de archivo aplicables. Esta obligaci\u00f3n puede ser cubierta por un contrato con el proveedor de software.", "prev_section_summary": "### Temas Clave\n\n1. **Calificaci\u00f3n de Instalaci\u00f3n (IQ)**:\n   - Importancia de la documentaci\u00f3n y pruebas para asegurar la correcta instalaci\u00f3n del sistema.\n   - Verificaci\u00f3n de recursos del sistema (hardware y software).\n   - Documentaci\u00f3n de componentes y versiones.\n   - Listado de usuarios y sus tipos de acceso.\n   - Pruebas de integraci\u00f3n y comunicaci\u00f3n con otros sistemas.\n\n2. **Calificaci\u00f3n Operativa (OQ)**:\n   - Comprobaci\u00f3n del funcionamiento adecuado del software mediante pruebas de funciones clave.\n   - Uso de conjuntos de datos conocidos para validar resultados.\n   - Documentaci\u00f3n de datos de entrada y salida, as\u00ed como capturas de pantalla.\n   - Repetici\u00f3n de la OQ tras cambios significativos en software o hardware, utilizando un enfoque basado en riesgos.\n\n### Entidades\n\n- **Sistemas Inform\u00e1ticos**: Sistemas que requieren validaci\u00f3n para asegurar su correcto funcionamiento en entornos IT.\n- **Hardware y Software**: Componentes necesarios para la instalaci\u00f3n y operaci\u00f3n del sistema.\n- **Usuarios**: Personas o grupos con acceso al sistema, cuya gesti\u00f3n es parte de la documentaci\u00f3n de la IQ.\n- **Proveedores**: Entidades que pueden apoyar en la instalaci\u00f3n y validaci\u00f3n del sistema.\n- **Datos de Prueba**: Conjuntos de datos utilizados para validar el funcionamiento del software durante la OQ.\n\n### Resumen\n\nLa secci\u00f3n aborda la validaci\u00f3n de sistemas inform\u00e1ticos complejos a trav\u00e9s de dos etapas fundamentales: la Calificaci\u00f3n de Instalaci\u00f3n (IQ) y la Calificaci\u00f3n Operativa (OQ). La IQ se centra en asegurar que el sistema est\u00e9 correctamente instalado y documentado, verificando recursos, componentes y accesos. La OQ, por su parte, se enfoca en comprobar el correcto funcionamiento del software mediante pruebas de funciones clave y la comparaci\u00f3n de resultados con valores esperados, adem\u00e1s de la necesidad de repetir estas pruebas tras cambios significativos en el sistema.", "excerpt_keywords": "Keywords: performance qualification, validation report, user requirements specification, data protection, archiving obligations"}}}}

vec_27_di/storage_nodes/graph_store.json

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+{"graph_dict": {}}

vec_27_di/storage_nodes/image__vector_store.json

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+{"embedding_dict": {}, "text_id_to_ref_doc_id": {}, "metadata_dict": {}}

vec_27_di/storage_nodes/index_store.json

@@ -0,0 +1 @@
+{"index_store/data": {"vector_index": {"__type__": "vector_store", "__data__": "{\"index_id\": \"vector_index\", \"summary\": null, \"nodes_dict\": {\"d5ce33e2-6e3a-42b9-a877-ee52f57b1cd1\": \"d5ce33e2-6e3a-42b9-a877-ee52f57b1cd1\", \"9d55f4a2-9d3f-462d-b909-1f337509e18b\": \"9d55f4a2-9d3f-462d-b909-1f337509e18b\", \"ea6d1619-4507-4b1c-9937-17b1edc6017c\": \"ea6d1619-4507-4b1c-9937-17b1edc6017c\", \"cf6692e8-0469-403d-87d5-7d027815de23\": \"cf6692e8-0469-403d-87d5-7d027815de23\"}, \"doc_id_dict\": {}, \"embeddings_dict\": {}}"}}}

vec_28_di/storage_nodes/default__vector_store.json

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procesadores de datos.pdf", "image_path": "", "parsed_text_markdown": "4.4. Los registros de gesti\u00f3n de calidad deben incluir informes de auditor\u00edas internas (y externas, si fueran realizadas) y revisiones de la gesti\u00f3n as\u00ed como los registros de todas las quejas y sus investigaciones, incluyendo posibles acciones preventivas y correctivas.\n\n# 5. Equipos procesadores de datos\n\n5.1. Recomendaciones detalladas son provistas en el Ap\u00e9ndice 5 del Anexo 4 del Cuadrag\u00e9simo Informe del Comit\u00e9 de Expertos de la OMS en especificaciones para Preparaciones Farmac\u00e9uticas: Gu\u00edas suplementarias en buenas pr\u00e1cticas de fabricaci\u00f3n: validaci\u00f3n. Validaci\u00f3n de sistemas computarizados (12).\n\n5.2. Para computadoras, equipos automatizados o de calibraci\u00f3n, y para la recolecci\u00f3n, procesamiento, registro, informe, almacenamiento o recuperaci\u00f3n de datos de an\u00e1lisis y/o calibraci\u00f3n, el laboratorio debe asegurar que:\n\na) El programa inform\u00e1tico desarrollado por el usuario est\u00e9 documentado con suficiente detalle y apropiadamente validado o verificado para demostrar que es adecuado para el uso;\n\nb) Se establezcan e implementen procedimientos para proteger la integridad de los datos. Tales procedimientos deben incluir, pero no se limitan a medidas para asegurar la integridad y confidencialidad del ingreso o recolecci\u00f3n de datos y el almacenamiento, transmisi\u00f3n y procesamiento de los datos. En particular, los datos electr\u00f3nicos deben estar protegidos contra el acceso no autorizado y debe mantenerse evidencia de cualquier enmienda;\n\nc) Las computadoras y equipos autom\u00e1ticos est\u00e9n mantenidos para que funcionen correctamente y est\u00e9n provistos con las condiciones operativas y ambientales necesarias para asegurar la integridad de los datos de ensayo y calibraci\u00f3n;\n\nd) Se establezcan e implementen los procedimientos para realizar, documentar y controlar los cambios de informaci\u00f3n almacenados en los sistemas computarizados; y\n\ne) Se realice una copia de seguridad de los datos electr\u00f3nicos a intervalos regulares apropiados, de acuerdo a un procedimiento documentado. Los datos copiados deben ser recuperables y almacenados de manera de evitar la p\u00e9rdida de datos.\n\n*Nota:* Para pautas adicionales en la validaci\u00f3n de equipos procesadores de datos, referirse a los documentos publicados por la Sociedad Internacional de Ingenier\u00eda Farmac\u00e9utica (13, 14), la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (15), la Comisi\u00f3n Europea (16) y la Red de Laboratorios Oficiales de Control de Medicamentos del Consejo de Europa (17).\n\n# 6. Personal\n\n6.1. El laboratorio debe tener suficiente personal con la educaci\u00f3n, capacitaci\u00f3n, conocimiento t\u00e9cnico y experiencia necesaria para sus funciones asignadas.\n\n6.2. La gerencia t\u00e9cnica debe asegurar la competencia de todas las personas que operan equipos espec\u00edficos, instrumentos u otros dispositivos, y que realizan ensayos y/o calibraciones, validaciones o verificaciones. Sus obligaciones incluyen tanto la evaluaci\u00f3n de resultados como la firma de los informes de an\u00e1lisis y certificados de an\u00e1lisis (ver Parte tres, secciones 18.7\u201318.11 y 19).", "parsed_text": "", "document_title": "INVIMA - Resoluci\u00f3n 3619 GLP 2013 - 5. Equipos procesadores de datos", "questions_this_excerpt_can_answer": "Aqu\u00ed tienes tres preguntas espec\u00edficas que se pueden responder con el contexto proporcionado, junto con un resumen de nivel superior:\n\n### Resumen de Nivel Superior\nEl documento se centra en las buenas pr\u00e1cticas de fabricaci\u00f3n (BPF) y la gesti\u00f3n de calidad en laboratorios, espec\u00edficamente en relaci\u00f3n con los equipos procesadores de datos. Se destacan las recomendaciones para la validaci\u00f3n de sistemas computarizados, la protecci\u00f3n de la integridad de los datos, y la importancia de contar con personal competente y capacitado. Se menciona la necesidad de mantener registros de auditor\u00edas, quejas y acciones correctivas, as\u00ed como la documentaci\u00f3n y validaci\u00f3n de software utilizado en el laboratorio.\n\n### Preguntas Espec\u00edficas\n\n1. **\u00bfQu\u00e9 procedimientos deben implementarse para garantizar la integridad de los datos en un laboratorio?**\n   - El laboratorio debe establecer e implementar procedimientos que aseguren la integridad y confidencialidad del ingreso o recolecci\u00f3n de datos, as\u00ed como el almacenamiento, transmisi\u00f3n y procesamiento de los datos. Esto incluye proteger los datos electr\u00f3nicos contra el acceso no autorizado y mantener evidencia de cualquier enmienda.\n\n2. **\u00bfCu\u00e1les son las responsabilidades de la gerencia t\u00e9cnica en relaci\u00f3n con el personal del laboratorio?**\n   - La gerencia t\u00e9cnica debe asegurar la competencia de todas las personas que operan equipos espec\u00edficos, instrumentos u otros dispositivos, y que realizan ensayos, calibraciones, validaciones o verificaciones. Esto incluye la evaluaci\u00f3n de resultados y la firma de informes de an\u00e1lisis y certificados de an\u00e1lisis.\n\n3. **\u00bfQu\u00e9 se debe considerar al realizar copias de seguridad de los datos electr\u00f3nicos en un laboratorio?**\n   - Se debe realizar una copia de seguridad de los datos electr\u00f3nicos a intervalos regulares apropiados, de acuerdo a un procedimiento documentado. Los datos copiados deben ser recuperables y almacenados de manera que se evite la p\u00e9rdida de datos.", "excerpt_keywords": "Keywords: buenas pr\u00e1cticas de fabricaci\u00f3n, integridad de datos, validaci\u00f3n de sistemas, personal competente, copias de seguridad", "_node_type": "TextNode", "document_id": "74fb6861-4e34-4af6-961f-9a8daba90709", "doc_id": "74fb6861-4e34-4af6-961f-9a8daba90709", "ref_doc_id": "74fb6861-4e34-4af6-961f-9a8daba90709"}}}

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+{"docstore/data": {"841b9de1-60cd-4c6e-a1a1-47aaf5bc640f": {"__data__": {"id_": "841b9de1-60cd-4c6e-a1a1-47aaf5bc640f", "embedding": null, "metadata": {"page_label": "1", "file_name": "[28] INVIMA Resoluci\u00f3n_3619 - GLP- 2013 5 Equipos procesadores de datos.pdf", "file_path": "Colombia/[28] INVIMA Resoluci\u00f3n_3619 - GLP- 2013 5 Equipos procesadores de datos.pdf", "image_path": "", "parsed_text_markdown": "4.4. Los registros de gesti\u00f3n de calidad deben incluir informes de auditor\u00edas internas (y externas, si fueran realizadas) y revisiones de la gesti\u00f3n as\u00ed como los registros de todas las quejas y sus investigaciones, incluyendo posibles acciones preventivas y correctivas.\n\n# 5. Equipos procesadores de datos\n\n5.1. Recomendaciones detalladas son provistas en el Ap\u00e9ndice 5 del Anexo 4 del Cuadrag\u00e9simo Informe del Comit\u00e9 de Expertos de la OMS en especificaciones para Preparaciones Farmac\u00e9uticas: Gu\u00edas suplementarias en buenas pr\u00e1cticas de fabricaci\u00f3n: validaci\u00f3n. Validaci\u00f3n de sistemas computarizados (12).\n\n5.2. Para computadoras, equipos automatizados o de calibraci\u00f3n, y para la recolecci\u00f3n, procesamiento, registro, informe, almacenamiento o recuperaci\u00f3n de datos de an\u00e1lisis y/o calibraci\u00f3n, el laboratorio debe asegurar que:\n\na) El programa inform\u00e1tico desarrollado por el usuario est\u00e9 documentado con suficiente detalle y apropiadamente validado o verificado para demostrar que es adecuado para el uso;\n\nb) Se establezcan e implementen procedimientos para proteger la integridad de los datos. Tales procedimientos deben incluir, pero no se limitan a medidas para asegurar la integridad y confidencialidad del ingreso o recolecci\u00f3n de datos y el almacenamiento, transmisi\u00f3n y procesamiento de los datos. En particular, los datos electr\u00f3nicos deben estar protegidos contra el acceso no autorizado y debe mantenerse evidencia de cualquier enmienda;\n\nc) Las computadoras y equipos autom\u00e1ticos est\u00e9n mantenidos para que funcionen correctamente y est\u00e9n provistos con las condiciones operativas y ambientales necesarias para asegurar la integridad de los datos de ensayo y calibraci\u00f3n;\n\nd) Se establezcan e implementen los procedimientos para realizar, documentar y controlar los cambios de informaci\u00f3n almacenados en los sistemas computarizados; y\n\ne) Se realice una copia de seguridad de los datos electr\u00f3nicos a intervalos regulares apropiados, de acuerdo a un procedimiento documentado. Los datos copiados deben ser recuperables y almacenados de manera de evitar la p\u00e9rdida de datos.\n\n*Nota:* Para pautas adicionales en la validaci\u00f3n de equipos procesadores de datos, referirse a los documentos publicados por la Sociedad Internacional de Ingenier\u00eda Farmac\u00e9utica (13, 14), la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (15), la Comisi\u00f3n Europea (16) y la Red de Laboratorios Oficiales de Control de Medicamentos del Consejo de Europa (17).\n\n# 6. Personal\n\n6.1. El laboratorio debe tener suficiente personal con la educaci\u00f3n, capacitaci\u00f3n, conocimiento t\u00e9cnico y experiencia necesaria para sus funciones asignadas.\n\n6.2. La gerencia t\u00e9cnica debe asegurar la competencia de todas las personas que operan equipos espec\u00edficos, instrumentos u otros dispositivos, y que realizan ensayos y/o calibraciones, validaciones o verificaciones. Sus obligaciones incluyen tanto la evaluaci\u00f3n de resultados como la firma de los informes de an\u00e1lisis y certificados de an\u00e1lisis (ver Parte tres, secciones 18.7\u201318.11 y 19).", "parsed_text": "", "document_title": "INVIMA - Resoluci\u00f3n 3619 GLP 2013 - 5. Equipos procesadores de datos", "questions_this_excerpt_can_answer": "Aqu\u00ed tienes tres preguntas espec\u00edficas que se pueden responder con el contexto proporcionado, junto con un resumen de nivel superior:\n\n### Resumen de Nivel Superior\nEl documento se centra en las buenas pr\u00e1cticas de fabricaci\u00f3n (BPF) y la gesti\u00f3n de calidad en laboratorios, espec\u00edficamente en relaci\u00f3n con los equipos procesadores de datos. Se destacan las recomendaciones para la validaci\u00f3n de sistemas computarizados, la protecci\u00f3n de la integridad de los datos, y la importancia de contar con personal competente y capacitado. Se menciona la necesidad de mantener registros de auditor\u00edas, quejas y acciones correctivas, as\u00ed como la documentaci\u00f3n y validaci\u00f3n de software utilizado en el laboratorio.\n\n### Preguntas Espec\u00edficas\n\n1. **\u00bfQu\u00e9 procedimientos deben implementarse para garantizar la integridad de los datos en un laboratorio?**\n   - El laboratorio debe establecer e implementar procedimientos que aseguren la integridad y confidencialidad del ingreso o recolecci\u00f3n de datos, as\u00ed como el almacenamiento, transmisi\u00f3n y procesamiento de los datos. Esto incluye proteger los datos electr\u00f3nicos contra el acceso no autorizado y mantener evidencia de cualquier enmienda.\n\n2. **\u00bfCu\u00e1les son las responsabilidades de la gerencia t\u00e9cnica en relaci\u00f3n con el personal del laboratorio?**\n   - La gerencia t\u00e9cnica debe asegurar la competencia de todas las personas que operan equipos espec\u00edficos, instrumentos u otros dispositivos, y que realizan ensayos, calibraciones, validaciones o verificaciones. Esto incluye la evaluaci\u00f3n de resultados y la firma de informes de an\u00e1lisis y certificados de an\u00e1lisis.\n\n3. **\u00bfQu\u00e9 se debe considerar al realizar copias de seguridad de los datos electr\u00f3nicos en un laboratorio?**\n   - Se debe realizar una copia de seguridad de los datos electr\u00f3nicos a intervalos regulares apropiados, de acuerdo a un procedimiento documentado. Los datos copiados deben ser recuperables y almacenados de manera que se evite la p\u00e9rdida de datos.", "excerpt_keywords": "Keywords: buenas pr\u00e1cticas de fabricaci\u00f3n, integridad de datos, validaci\u00f3n de sistemas, personal competente, copias de seguridad"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "74fb6861-4e34-4af6-961f-9a8daba90709", "node_type": "4", "metadata": {"page_label": "1", "file_name": "[28] INVIMA Resoluci\u00f3n_3619 - GLP- 2013 5 Equipos procesadores de datos.pdf", "file_path": "Colombia/[28] INVIMA Resoluci\u00f3n_3619 - GLP- 2013 5 Equipos procesadores de datos.pdf", "image_path": "", "parsed_text_markdown": "4.4. Los registros de gesti\u00f3n de calidad deben incluir informes de auditor\u00edas internas (y externas, si fueran realizadas) y revisiones de la gesti\u00f3n as\u00ed como los registros de todas las quejas y sus investigaciones, incluyendo posibles acciones preventivas y correctivas.\n\n# 5. Equipos procesadores de datos\n\n5.1. Recomendaciones detalladas son provistas en el Ap\u00e9ndice 5 del Anexo 4 del Cuadrag\u00e9simo Informe del Comit\u00e9 de Expertos de la OMS en especificaciones para Preparaciones Farmac\u00e9uticas: Gu\u00edas suplementarias en buenas pr\u00e1cticas de fabricaci\u00f3n: validaci\u00f3n. Validaci\u00f3n de sistemas computarizados (12).\n\n5.2. Para computadoras, equipos automatizados o de calibraci\u00f3n, y para la recolecci\u00f3n, procesamiento, registro, informe, almacenamiento o recuperaci\u00f3n de datos de an\u00e1lisis y/o calibraci\u00f3n, el laboratorio debe asegurar que:\n\na) El programa inform\u00e1tico desarrollado por el usuario est\u00e9 documentado con suficiente detalle y apropiadamente validado o verificado para demostrar que es adecuado para el uso;\n\nb) Se establezcan e implementen procedimientos para proteger la integridad de los datos. Tales procedimientos deben incluir, pero no se limitan a medidas para asegurar la integridad y confidencialidad del ingreso o recolecci\u00f3n de datos y el almacenamiento, transmisi\u00f3n y procesamiento de los datos. En particular, los datos electr\u00f3nicos deben estar protegidos contra el acceso no autorizado y debe mantenerse evidencia de cualquier enmienda;\n\nc) Las computadoras y equipos autom\u00e1ticos est\u00e9n mantenidos para que funcionen correctamente y est\u00e9n provistos con las condiciones operativas y ambientales necesarias para asegurar la integridad de los datos de ensayo y calibraci\u00f3n;\n\nd) Se establezcan e implementen los procedimientos para realizar, documentar y controlar los cambios de informaci\u00f3n almacenados en los sistemas computarizados; y\n\ne) Se realice una copia de seguridad de los datos electr\u00f3nicos a intervalos regulares apropiados, de acuerdo a un procedimiento documentado. Los datos copiados deben ser recuperables y almacenados de manera de evitar la p\u00e9rdida de datos.\n\n*Nota:* Para pautas adicionales en la validaci\u00f3n de equipos procesadores de datos, referirse a los documentos publicados por la Sociedad Internacional de Ingenier\u00eda Farmac\u00e9utica (13, 14), la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (15), la Comisi\u00f3n Europea (16) y la Red de Laboratorios Oficiales de Control de Medicamentos del Consejo de Europa (17).\n\n# 6. Personal\n\n6.1. El laboratorio debe tener suficiente personal con la educaci\u00f3n, capacitaci\u00f3n, conocimiento t\u00e9cnico y experiencia necesaria para sus funciones asignadas.\n\n6.2. La gerencia t\u00e9cnica debe asegurar la competencia de todas las personas que operan equipos espec\u00edficos, instrumentos u otros dispositivos, y que realizan ensayos y/o calibraciones, validaciones o verificaciones. Sus obligaciones incluyen tanto la evaluaci\u00f3n de resultados como la firma de los informes de an\u00e1lisis y certificados de an\u00e1lisis (ver Parte tres, secciones 18.7\u201318.11 y 19).", "parsed_text": "", "document_title": "INVIMA - Resoluci\u00f3n 3619 GLP 2013 - 5. Equipos procesadores de datos"}, "hash": "20586aa2bcff088bae6224b949a0c643d7d53a292eb743ae1f5e0a0b6b6e326e", "class_name": "RelatedNodeInfo"}}, "metadata_template": "{key}: {value}", "metadata_separator": "\n", "text": "4.4. Los registros de gesti\u00f3n de calidad deben incluir informes de auditor\u00edas internas (y externas, si fueran realizadas) y revisiones de la gesti\u00f3n as\u00ed como los registros de todas las quejas y sus investigaciones, incluyendo posibles acciones preventivas y correctivas.\n\n# 5. Equipos procesadores de datos\n\n5.1. Recomendaciones detalladas son provistas en el Ap\u00e9ndice 5 del Anexo 4 del Cuadrag\u00e9simo Informe del Comit\u00e9 de Expertos de la OMS en especificaciones para Preparaciones Farmac\u00e9uticas: Gu\u00edas suplementarias en buenas pr\u00e1cticas de fabricaci\u00f3n: validaci\u00f3n. Validaci\u00f3n de sistemas computarizados (12).\n\n5.2. Para computadoras, equipos automatizados o de calibraci\u00f3n, y para la recolecci\u00f3n, procesamiento, registro, informe, almacenamiento o recuperaci\u00f3n de datos de an\u00e1lisis y/o calibraci\u00f3n, el laboratorio debe asegurar que:\n\na) El programa inform\u00e1tico desarrollado por el usuario est\u00e9 documentado con suficiente detalle y apropiadamente validado o verificado para demostrar que es adecuado para el uso;\n\nb) Se establezcan e implementen procedimientos para proteger la integridad de los datos. Tales procedimientos deben incluir, pero no se limitan a medidas para asegurar la integridad y confidencialidad del ingreso o recolecci\u00f3n de datos y el almacenamiento, transmisi\u00f3n y procesamiento de los datos. En particular, los datos electr\u00f3nicos deben estar protegidos contra el acceso no autorizado y debe mantenerse evidencia de cualquier enmienda;\n\nc) Las computadoras y equipos autom\u00e1ticos est\u00e9n mantenidos para que funcionen correctamente y est\u00e9n provistos con las condiciones operativas y ambientales necesarias para asegurar la integridad de los datos de ensayo y calibraci\u00f3n;\n\nd) Se establezcan e implementen los procedimientos para realizar, documentar y controlar los cambios de informaci\u00f3n almacenados en los sistemas computarizados; y\n\ne) Se realice una copia de seguridad de los datos electr\u00f3nicos a intervalos regulares apropiados, de acuerdo a un procedimiento documentado. Los datos copiados deben ser recuperables y almacenados de manera de evitar la p\u00e9rdida de datos.\n\n*Nota:* Para pautas adicionales en la validaci\u00f3n de equipos procesadores de datos, referirse a los documentos publicados por la Sociedad Internacional de Ingenier\u00eda Farmac\u00e9utica (13, 14), la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (15), la Comisi\u00f3n Europea (16) y la Red de Laboratorios Oficiales de Control de Medicamentos del Consejo de Europa (17).\n\n# 6. Personal\n\n6.1. El laboratorio debe tener suficiente personal con la educaci\u00f3n, capacitaci\u00f3n, conocimiento t\u00e9cnico y experiencia necesaria para sus funciones asignadas.\n\n6.2. La gerencia t\u00e9cnica debe asegurar la competencia de todas las personas que operan equipos espec\u00edficos, instrumentos u otros dispositivos, y que realizan ensayos y/o calibraciones, validaciones o verificaciones. Sus obligaciones incluyen tanto la evaluaci\u00f3n de resultados como la firma de los informes de an\u00e1lisis y certificados de an\u00e1lisis (ver Parte tres, secciones 18.7\u201318.11 y 19).", "mimetype": "text/plain", "start_char_idx": 0, "end_char_idx": 3031, "metadata_seperator": "\n", "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "class_name": "TextNode"}, "__type__": "1"}}, "docstore/metadata": {"841b9de1-60cd-4c6e-a1a1-47aaf5bc640f": {"doc_hash": "e27d8ca7e5f5f235c957b33a7d69ed10b652641cd88e28be06cac86b7a3a47e5", "ref_doc_id": "74fb6861-4e34-4af6-961f-9a8daba90709"}}, "docstore/ref_doc_info": {"74fb6861-4e34-4af6-961f-9a8daba90709": {"node_ids": ["841b9de1-60cd-4c6e-a1a1-47aaf5bc640f"], "metadata": {"page_label": "1", "file_name": "[28] INVIMA Resoluci\u00f3n_3619 - GLP- 2013 5 Equipos procesadores de datos.pdf", "file_path": "Colombia/[28] INVIMA Resoluci\u00f3n_3619 - GLP- 2013 5 Equipos procesadores de datos.pdf", "image_path": "", "parsed_text_markdown": "4.4. Los registros de gesti\u00f3n de calidad deben incluir informes de auditor\u00edas internas (y externas, si fueran realizadas) y revisiones de la gesti\u00f3n as\u00ed como los registros de todas las quejas y sus investigaciones, incluyendo posibles acciones preventivas y correctivas.\n\n# 5. Equipos procesadores de datos\n\n5.1. Recomendaciones detalladas son provistas en el Ap\u00e9ndice 5 del Anexo 4 del Cuadrag\u00e9simo Informe del Comit\u00e9 de Expertos de la OMS en especificaciones para Preparaciones Farmac\u00e9uticas: Gu\u00edas suplementarias en buenas pr\u00e1cticas de fabricaci\u00f3n: validaci\u00f3n. Validaci\u00f3n de sistemas computarizados (12).\n\n5.2. Para computadoras, equipos automatizados o de calibraci\u00f3n, y para la recolecci\u00f3n, procesamiento, registro, informe, almacenamiento o recuperaci\u00f3n de datos de an\u00e1lisis y/o calibraci\u00f3n, el laboratorio debe asegurar que:\n\na) El programa inform\u00e1tico desarrollado por el usuario est\u00e9 documentado con suficiente detalle y apropiadamente validado o verificado para demostrar que es adecuado para el uso;\n\nb) Se establezcan e implementen procedimientos para proteger la integridad de los datos. Tales procedimientos deben incluir, pero no se limitan a medidas para asegurar la integridad y confidencialidad del ingreso o recolecci\u00f3n de datos y el almacenamiento, transmisi\u00f3n y procesamiento de los datos. En particular, los datos electr\u00f3nicos deben estar protegidos contra el acceso no autorizado y debe mantenerse evidencia de cualquier enmienda;\n\nc) Las computadoras y equipos autom\u00e1ticos est\u00e9n mantenidos para que funcionen correctamente y est\u00e9n provistos con las condiciones operativas y ambientales necesarias para asegurar la integridad de los datos de ensayo y calibraci\u00f3n;\n\nd) Se establezcan e implementen los procedimientos para realizar, documentar y controlar los cambios de informaci\u00f3n almacenados en los sistemas computarizados; y\n\ne) Se realice una copia de seguridad de los datos electr\u00f3nicos a intervalos regulares apropiados, de acuerdo a un procedimiento documentado. Los datos copiados deben ser recuperables y almacenados de manera de evitar la p\u00e9rdida de datos.\n\n*Nota:* Para pautas adicionales en la validaci\u00f3n de equipos procesadores de datos, referirse a los documentos publicados por la Sociedad Internacional de Ingenier\u00eda Farmac\u00e9utica (13, 14), la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (15), la Comisi\u00f3n Europea (16) y la Red de Laboratorios Oficiales de Control de Medicamentos del Consejo de Europa (17).\n\n# 6. Personal\n\n6.1. El laboratorio debe tener suficiente personal con la educaci\u00f3n, capacitaci\u00f3n, conocimiento t\u00e9cnico y experiencia necesaria para sus funciones asignadas.\n\n6.2. La gerencia t\u00e9cnica debe asegurar la competencia de todas las personas que operan equipos espec\u00edficos, instrumentos u otros dispositivos, y que realizan ensayos y/o calibraciones, validaciones o verificaciones. Sus obligaciones incluyen tanto la evaluaci\u00f3n de resultados como la firma de los informes de an\u00e1lisis y certificados de an\u00e1lisis (ver Parte tres, secciones 18.7\u201318.11 y 19).", "parsed_text": "", "document_title": "INVIMA - Resoluci\u00f3n 3619 GLP 2013 - 5. Equipos procesadores de datos", "questions_this_excerpt_can_answer": "Aqu\u00ed tienes tres preguntas espec\u00edficas que se pueden responder con el contexto proporcionado, junto con un resumen de nivel superior:\n\n### Resumen de Nivel Superior\nEl documento se centra en las buenas pr\u00e1cticas de fabricaci\u00f3n (BPF) y la gesti\u00f3n de calidad en laboratorios, espec\u00edficamente en relaci\u00f3n con los equipos procesadores de datos. Se destacan las recomendaciones para la validaci\u00f3n de sistemas computarizados, la protecci\u00f3n de la integridad de los datos, y la importancia de contar con personal competente y capacitado. Se menciona la necesidad de mantener registros de auditor\u00edas, quejas y acciones correctivas, as\u00ed como la documentaci\u00f3n y validaci\u00f3n de software utilizado en el laboratorio.\n\n### Preguntas Espec\u00edficas\n\n1. **\u00bfQu\u00e9 procedimientos deben implementarse para garantizar la integridad de los datos en un laboratorio?**\n   - El laboratorio debe establecer e implementar procedimientos que aseguren la integridad y confidencialidad del ingreso o recolecci\u00f3n de datos, as\u00ed como el almacenamiento, transmisi\u00f3n y procesamiento de los datos. Esto incluye proteger los datos electr\u00f3nicos contra el acceso no autorizado y mantener evidencia de cualquier enmienda.\n\n2. **\u00bfCu\u00e1les son las responsabilidades de la gerencia t\u00e9cnica en relaci\u00f3n con el personal del laboratorio?**\n   - La gerencia t\u00e9cnica debe asegurar la competencia de todas las personas que operan equipos espec\u00edficos, instrumentos u otros dispositivos, y que realizan ensayos, calibraciones, validaciones o verificaciones. Esto incluye la evaluaci\u00f3n de resultados y la firma de informes de an\u00e1lisis y certificados de an\u00e1lisis.\n\n3. **\u00bfQu\u00e9 se debe considerar al realizar copias de seguridad de los datos electr\u00f3nicos en un laboratorio?**\n   - Se debe realizar una copia de seguridad de los datos electr\u00f3nicos a intervalos regulares apropiados, de acuerdo a un procedimiento documentado. Los datos copiados deben ser recuperables y almacenados de manera que se evite la p\u00e9rdida de datos.", "excerpt_keywords": "Keywords: buenas pr\u00e1cticas de fabricaci\u00f3n, integridad de datos, validaci\u00f3n de sistemas, personal competente, copias de seguridad"}}}}

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vec_28_di/storage_nodes/index_store.json

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vec_32_di/storage_nodes/index_store.json

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