SIMO 2006 Sesion Técnica del ATI

Transcription

1 SIMO 2006 Sesion Técnica del ATI Telelogic: Una compañía en la que puede confiar Financieramente Saludable En el mercado durante los últimos 22 años Crecimiento continuo en 2004/2005 Con beneficios, balance de caja positivo, sin deudas Presencia Global Oficinas en 22 países en todo el mundo Soporte 24x7 Desarrollo Global Liderazgo de Mercado Soluciones lideres para todo el ciclo de vida Herramientas lideres en su clase Más de licencias en todo el mundo Lideres en la definición de los estándares: UML, BPMN, SysML,.. 1

2 Ingresos y Beneficios en Crecimiento Comunicaciones Gracias a Nuestros Clientes Militar Aeroespacial Transportes Automóviles Finanzas Seguros Comercio 2

3 Telelogic Lideres en Gestión de Requisitos 3

4 Lideres en Gestión de Configuración Lideres en Análisis y Diseño UML 4

5 Demo Arquitectura de la Información Estructura de la Información Proyecto TI Propuestas de Cambio Nuevos Requisitos SYNERGY/Change Especifiación de Requisitos Satisfacen Prueban Analisis Pruebas Herramientas Utilizadas Telelogic Telelogic /Analyst Telelogic Synergy/Change / XT Implementan Ordenes de Implementación Tareas SYNERGY/CM SYNERGY/Change 5

6 User Change Requests Telelogic Dashboard for Synergy and Safety Describe User Manuals Legacy Code User Requirements Satisface Satisface SSS UML Design Satisface / TAU G2 Integration TAU/G2 Developer C++, ADA and Corba exporting/importing SSDD /Analyst SRS SRS SRS /Analyst Satisface Satisface Participa en SDD Implementa modifica / Synergy/Change modifica Code Synergy/CM Logiscope SYNERGY/Change Requirements & Tests Change Requests / Synergy/Change Verifica / Synergy/Change Verifica Verifica verifica PCI PPS Unit PPS PPS Design PPS System Valida Testing verifica Test Tracking Tool verifica Functional Testing Test Tracking Tool Testing Acceptance Testing Test Plan Contenido en / Synergy/Change Genera Testing Reporting with WEXP Observations & Program Trouble Reports SYNERGY/Change Propuestas de Cambio Nuevos Requisitos SYNERGY/Change Especifiación de Requisitos Prueban Satisfacen Pruebas Analisis / XT Implementan Ordenes de Implementación Tareas SYNERGY/CM SYNERGY/Change 6

7 Herramientas Telelogic Telelogic se adapta a su compañía Procesos out-of-the-box (Project Startup Wizard) Proyectos de Software o Sistema Crea documentos típicos Añade atributos, vistas, informes, Adaptación a los procesos de su compañía Refuerza las buenas prácticas de su compañía Fácil adaptación de documentos y atributos a través de menús y wizards Adaptación en más profundidad con DXL ( extended Language) Sistemas de Plantillas para la definición y mantenimiento Chequeo de reglas de estilo 7

8 Gestión de Requisitos a Nivel Documental Proporciona contexto a la gestión de requisitos Requisitos e información complementaría están en el mismo repositorio facilitando la legibilidad y mantenimiento Facilita la generación de la documentación asociada a la gestión de requisitos Facilita la Reutilización Información ordenada y de fácil acceso Barras de cambio e indicadores de links; trazabilidad instantánea 8

9 Histórico y baselines Histórico del requisito Baseline previa Deshacer cualquier cambio Versión actual /Analyst Modelado visual UML dentro de la herramienta líder de Gestión de Requisitos Soporte completo a UML 2.0 Elementos del documento pueden ser categorizados como entidades UML Trazabilidad entre requisitos y elementos UML Diseño UML como enriquecedor de la información textual Diseño UML en contexto con los requisitos Lo mejor de ambas metodologías en un único entorno Facilidad para la generación de documentación 9

10 (b) Design and Development Planning Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed as design and development evolves. The plans shall be updated as design and development evolves. The plans shall be approved as design and development evolves (c) Design Input 2.1. Each manufacturer shall establish s to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient Each manufacturer shall maintain s to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient The s shall include a mechanism for addressing incomplete requirements The s shall include a mechanism for addressing ambiguous requirements The s shall include a mechanism for addressing conflicting requirements The design input requirements shall be documented by a designated individual(s) The design input requirements shall be reviewed by a designated individual(s) The design input requirements shall be approved by a designated individual(s) The approval, including the date and signature of the individual(s) approving the requirements, shall be documented Questions Summarize the manufacturer's written (s) for identification and control of design input From what sources are design inputs sought? Do design input s cover the relevant aspects, such as: (Mark all that apply and list additional aspects.) intended use user/patient/clinical performance characteristics safety limits and tolerances risk analysis toxicity and biocompatibility electromagnetic compatibility (EMC) compatibility with accessories/auxiliary devices compatibility with the environment of intended use human factors physical/chemical characteristics labeling/packaging reliability statutory and regulatory requirements voluntary standards manufacturing processes sterility MDRs/complaints/failures and other historical data design history files (DHFs) For the specific design covered, how were the design input requirements identified? For the specific design covered, how were the design input requirements reviewed for adequacy? (b) Design and Development Planning Comply with FDA Design Control Guidance GMP Regulation Each manufacturer shall establish and maintain plans that describe or reference the design and development 1. Capture design and related information activities and define responsibility for implementation Input electronically formatted data 1.2. Reference external information The plans sources shall identify and describe the interfaces with different groups or activities that provide, or result 1.3. Reference external documentation in, input to the design and development process. 2. Store design and related information The plans shall be reviewed as design and development evolves Identify and tag design information The plans shall as unique be updated design as design elements and development evolves Organize design elements The plans shall be approved as design and development evolves Organize by Design Control Guidance Element Organize by inter-relationships (c) Design Input 2.3. Ensure all design elements are 2.1. available Each manufacturer shall establish s to ensure that the design requirements relating to a Store design elements by Design device Control are appropriate Guidance and Element address the intended use of the device, including the needs of the user Store design elements and their and historical patient. values 2.2. Each manufacturer shall maintain s to ensure that the design requirements relating to a 3. Manage all user needs device are appropriate and address the intended use of the device, including the needs of the user 3.1. Identify the source of the user need and patient Identify all user types (groups) 2.3. The s shall include a mechanism for addressing incomplete requirements Identify the customer (s) 2.4. The s shall include a mechanism for addressing ambiguous requirements Profile the expected patients 2.5. The s shall include a mechanism for addressing conflicting requirements State the intended use of the 2.6. product The (family) design input requirements shall be documented by a designated individual(s) Capture the acceptance criteria 2.7. for The each design user need input requirements shall be reviewed by a designated individual(s) The design input requirements shall be approved by a designated individual(s). 4. Manage design input requirements2.9. The approval, including the date and signature of the individual(s) approving the requirements, 4.1. Identify the source of the requirement shall be documented Identify the associated user need Questions Capture requirement description and attributes Summarize the manufacturer's written (s) for identification and control of 4.4. Capture acceptance criteria design input Assign responsibility for each requirement From what sources are design inputs sought? 4.6. Manage incomplete requirements Do design input s cover the relevant aspects, such as: (Mark all that apply and 4.7. Manage ambiguous requirements list additional aspects.) 4.8. Manage conflicting requirements intended use 4.9. Approve all requirements user/patient/clinical performance characteristics 5. Manage acceptance safety 5.1. Ensure the acceptance of every user need limits and tolerances 5.2. Ensure the acceptance of every design input requirement risk analysis 5.3. Document the results of every user need acceptance toxicity test and biocompatibility 5.4. Document the results of every design input requirements electromagnetic test compatibility (EMC) 5.5. Make acceptance results available compatibility with accessories/auxiliary devices compatibility with the environment of intended use 6. Manage change human factors 6.1. Maintain history of design element changes physical/chemical characteristics Make complete change history available labeling/packaging Maintain history within and across any organizational reliability Maintain history within and across any project statutory milestone and regulatory requirements Maintain history within and across any Design voluntary Control standards Guidance Elements 6.2. Capture frequency and nature of element changes manufacturing processes Provide rationale for change sterility Describe decisions made MDRs/complaints/failures and other historical data Identify approval authority for the change design history files (DHFs) Capture date, time, and signature of approving For the specific authority design covered, how were the design input requirements identified? 6.3. Identify impacted elements due to a change For in the another specific element design covered, how were the design input requirements reviewed for Create backward traces to design elements adequacy? within and across any organizational Create backward traces to design elements within and across any project milestone Comply with FDA Design Control Guidance GMP Regulation 1. Capture design and related information 1.1. Input electronically formatted data 1.2. Reference external information sources 1.3. Reference external documentation 2. Store design and related information 2.1. Identify and tag design information as unique design elements 2.2. Organize design elements Organize by Design Control Guidance Element Organize by inter-relationships 2.3. Ensure all design elements are available Store design elements by Design Control Guidance Element Store design elements and their historical values 3. Manage all user needs 3.1. Identify the source of the user need 3.2. Identify all user types (groups) 3.3. Identify the customer (s) 3.4. Profile the expected patients 3.5. State the intended use of the product (family) 3.6. Capture the acceptance criteria for each user need 4. Manage design input requirements 4.1. Identify the source of the requirement 4.2. Identify the associated user need 4.3. Capture requirement description and attributes 4.4. Capture acceptance criteria 4.5. Assign responsibility for each requirement 4.6. Manage incomplete requirements 4.7. Manage ambiguous requirements 4.8. Manage conflicting requirements 4.9. Approve all requirements 5. Manage acceptance 5.1. Ensure the acceptance of every user need 5.2. Ensure the acceptance of every design input requirement 5.3. Document the results of every user need acceptance test 5.4. Document the results of every design input requirements test 5.5. Make acceptance results available 6. Manage change 6.1. Maintain history of design element changes Make complete change history available Maintain history within and across any organizational Maintain history within and across any project milestone Maintain history within and across any Design Control Guidance Elements 6.2. Capture frequency and nature of element changes Provide rationale for change Describe decisions made Identify approval authority for the change Capture date, time, and signature of approving authority 6.3. Identify impacted elements due to a change in another element Create backward traces to design elements within and across any organizational Create backward traces to design elements within and across any project milestone Cruzadas Refeencias Documentos Gestión de la Trazabilidad sin Req. Usuario Especificaciones Informes Pruebas 1.1. Identify impacted elements due to a change in another element Traceability Reports: consistency with driving design elements Impact Reports: other design elements affected Links to impacted design elements Create backward traces to design elements within and across any organizational Traceability Reports: Procedure Attribute Create backward traces to design elements within and across any project milestone Traceability Reports: Milestone Attribute Create backward traces to design elements within and across Design Control Guidance Elements Traceability Reports: Linked design elements Create forward impacts to design elements within and across any organizational Impact Reports: Procedure Attribute Create forward impacts to design elements within and across any project milestone Impact Reports: Milestone Attribute Create forward impacts to design elements within and across Design Control Guidance Elements Impact Reports: Linked design elements 1.2. Associate changed design elements with related elements Link Change Design Object with affected design element(s) Traceability Links and Reports from affected design element(s) Impact Links and Reports from affected design element(s) Associate design element changes with decisions, rationale, and approval authority information Change Decision Objects with following Attributes: Disposition Attribute Decision Attribute Rationale Attribute Owner Attribute Management Approval Attribute Provide associations within and across any organizational Change Design Object Traceability Link on Procedure Attribute Change Design Object Impacts Link on Procedure Attribute Provide associations within and across any project milestone Change Design Object Traceability Link on Milestone Attribute Change Design Object Impacts Link on Milestone Attribute Provide associations within and across Design Control Guidance Elements Change Design Object Traceability Link to traced design elements Change Design Object Impacts Link to linked design elements 1.3. Mange the change process Design Change Module Design Change Reports Object History Object History Reports Versions Baselines 1.1. Identify impacted elements due to a change in another element Traceability Reports: consistency with driving design elements Impact Reports: other design elements affected Links to impacted design elements Create backward traces to design elements within and across any organizational Traceability Reports: Procedure Attribute Create backward traces to design elements within and across any project milestone Traceability Reports: Milestone Attribute Create backward traces to design elements within and across Design Control Guidance Elements Traceability Reports: Linked design elements Create forward impacts to design elements within and across any organizational Impact Reports: Procedure Attribute Create forward impacts to design elements within and across any project milestone Impact Reports: Milestone Attribute Create forward impacts to design elements within and across Design Control Guidance Elements Impact Reports: Linked design elements 1.2. Associate changed design elements with related elements Link Change Design Object with affected design element(s) Traceability Links and Reports from affected design element(s) Impact Links and Reports from affected design element(s) Associate design element changes with decisions, rationale, and approval authority information Change Decision Objects with following Attributes: Disposition Attribute Decision Attribute Rationale Attribute Owner Attribute Management Approval Attribute Provide associations within and across any organizational Change Design Object Traceability Link on Procedure Attribute Change Design Object Impacts Link on Procedure Attribute Provide associations within and across any project milestone Change Design Object Traceability Link on Milestone Attribute Change Design Object Impacts Link on Milestone Attribute Provide associations within and across Design Control Guidance Elements Change Design Object Traceability Link to traced design elements Change Design Object Impacts Link to linked design elements 1.3. Mange the change process Design Change Module Design Change Reports Object History Object History Reports Versions Baselines Creación de Enlaces Drag-anddrop para unir dentro de un documento..... O de un documento a otro 10

11 (b) Design and Development Planning Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed as design and development evolves. The plans shall be updated as design and development evolves. The plans shall be approved as design and development evolves (c) Design Input 2.1. Each manufacturer shall establish s to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient Each manufacturer shall maintain s to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient The s shall include a mechanism for addressing incomplete requirements The s shall include a mechanism for addressing ambiguous requirements The s shall include a mechanism for addressing conflicting requirements The design input requirements shall be documented by a designated individual(s) The design input requirements shall be reviewed by a designated individual(s) The design input requirements shall be approved by a designated individual(s) The approval, including the date and signature of the individual(s) approving the requirements, shall be documented Questions Summarize the manufacturer's written (s) for identification and control of design input From what sources are design inputs sought? Do design input s cover the relevant aspects, such as: (Mark all that apply and list additional aspects.) intended use user/patient/clinical performance characteristics safety limits and tolerances risk analysis toxicity and biocompatibility electromagnetic compatibility (EMC) compatibility with accessories/auxiliary devices compatibility with the environment of intended use human factors physical/chemical characteristics labeling/packaging voluntary standards manufacturing processes sterility MDRs/complaints/failures and other historical data design history files (DHFs) For the specific design covered, how were the design input requirements identified? For the specific design covered, how were the design input requirements reviewed for adequacy? (b) Design and Development Planning Comply with FDA Design Control Guidance GMP Regulation Comply with FDA Design Control Guidance GMP Regulation Each manufacturer shall establish and maintain plans that describe or reference the design 1.1. Identify and development impacted elements due to a change in another element 1. Capture design and related information activities and define responsibility for implementation. 1. Capture design and related information 1.1. Input electronically formatted data 1.1. Input electronically formatted data 1.2. Reference external information The plans sources shall identify and describe the interfaces with different groups or activities that provide, or result 1.2. Reference external information sources 1.3. Reference external documentation in, input to the design and development process Reference external documentation Create backward traces to design elements within and across any organizational 2. Store design and related information The plans shall be reviewed as design and development evolves. 2. Store design and related information 2.1. Identify and tag design information The plans shall as unique be updated design as design elements and development evolves Identify and tag design information as unique design elements 2.2. Organize design elements The plans shall be approved as design and development evolves Organize design elements Create backward traces to design elements within and across any project milestone Organize by Design Control Guidance Element Organize by Design Control Guidance Element Organize by inter-relationships (c) Design Input Organize by inter-relationships 2.3. Ensure all design elements are 2.1. available Each manufacturer shall establish s to ensure that the design requirements relating Create to backward a traces to design 2.3. Ensure elements all design within elements and are across available Design Control Store design elements by Design device Control are appropriate Guidance and Element address the intended use of the device, including the needs Guidance of the user Elements Store design elements by Design Control Guidance Element Store design elements and their and historical patient. values Store design elements and their historical values 2.2. Each manufacturer shall maintain s to ensure that the design requirements relating to a 3. Manage all user needs device are appropriate and address the intended use of the device, including the needs Create of the user forward impacts 3. to design Manage elements all user needs within and across any organizational 3.1. Identify the source of the user need and patient Identify the source of the user need 3.2. Identify all user types (groups) 2.3. The s shall include a mechanism for addressing incomplete requirements Identify all user types (groups) 3.3. Identify the customer (s) 2.4. The s shall include a mechanism for addressing ambiguous requirements Create forward impacts to design 3.3. Identify elements the customer within (s) and across any project milestone 3.4. Profile the expected patients2.5. The s shall include a mechanism for addressing conflicting requirements Profile the expected patients 3.5. State the intended use of the 2.6. product The (family) design input requirements shall be documented by a designated individual(s) State the intended use of the product (family) 3.6. Capture the acceptance criteria 2.7. for The each design user need input requirements shall be reviewed by a designated individual(s) Create forward impacts to design 3.6. Capture elements the acceptance within and criteria across for each Design user need Control 2.8. The design input requirements shall be approved by a designated individual(s). Guidance Elements 4. Manage design input requirements2.9. The approval, including the date and signature of the individual(s) approving the requirements, 4. Manage design input requirements 4.1. Identify the source of the requirement shall be documented Identify the source of the requirement Questions Associate changed design elements with related elements 4.2. Identify the associated user need 4.2. Identify the associated user need 4.3. Capture requirement description and attributes Summarize the manufacturer's written (s) for identification and control of 4.3. Capture requirement description and attributes 4.4. Capture acceptance criteria design input Capture acceptance criteria 4.5. Assign responsibility for each requirement From what sources are design inputs sought? 4.5. Assign responsibility for each requirement 4.6. Manage incomplete requirements Do design input s cover the relevant aspects, such as: (Mark all that apply and 4.6. Manage incomplete requirements list additional aspects.) Associate design element changes with decisions, rationale, and approval authority 4.7. Manage ambiguous requirements 4.7. Manage ambiguous requirements 4.8. Manage conflicting requirements intended use information 4.8. Manage conflicting requirements 4.9. Approve all requirements user/patient/clinical 4.9. Approve all requirements performance characteristics 5. Manage acceptance safety 5. Manage acceptance 5.1. Ensure the acceptance of every user need limits and tolerances 5.1. Ensure the acceptance of every user need 5.2. Ensure the acceptance of every design input requirement risk analysis 5.2. Ensure the acceptance of every design input requirement 5.3. Document the results of every user need acceptance toxicity test and biocompatibility 5.3. Document the results of every user need acceptance test 5.4. Document the results of every design input requirements electromagnetic test compatibility (EMC) 5.4. Document the results of every design input requirements test 5.5. Make acceptance results available compatibility with accessories/auxiliary devices 5.5. Make acceptance results available compatibility with the environment of intended use Provide associations within and across any organizational 6. Manage change human factors 6. Manage change 6.1. Maintain history of design element changes physical/chemical characteristics 6.1. Maintain history of design element changes Make complete change history available labeling/packaging Provide associations within and across Make any complete project change milestone history available Maintain history within and across any organizational reliability Maintain history within and across any organizational Maintain history within and across any project statutory milestone and regulatory requirements Maintain history within and across any project milestone Maintain history within and across any Design voluntary Control standards Guidance Elements Maintain history within and across any Design Control Guidance Elements 6.2. Capture frequency and nature of element changes manufacturing processes Provide associations within 6.2. and Capture across frequency Design and Control nature Guidance of element Elements changes Provide rationale for change sterility Provide rationale for change Describe decisions made MDRs/complaints/failures and other historical data Describe decisions made Identify approval authority for the change design history files (DHFs) Identify approval authority for the change Capture date, time, and signature of approving For the specific authority design covered, how were the design input requirements 1.3. Mange identified? the change process Capture date, time, and signature of approving authority 6.3. Identify impacted elements due to a change For in the another specific element design covered, how were the design input requirements reviewed for 6.3. Identify impacted elements due to a change in another element Create backward traces to design elements adequacy? within and across any organizational Create backward traces to design elements within and across any organizational Create backward traces to design elements within and across any project milestone Create backward traces to design elements within and across any project milestone 1.1. Identify impacted elements due to a change in another element Create backward traces to design elements within and across any organizational Create backward traces to design elements within and across any project milestone Create backward traces to design elements within and across Design Control Guidance Elements Create forward impacts to design elements within and across any organizational Create forward impacts to design elements within and across any project milestone Create forward impacts to design elements within and across Design Control Guidance Elements 1.2. Associate changed design elements with related elements Associate design element changes with decisions, rationale, and approval authority information Provide associations within and across any organizational Provide associations within and across any project milestone Provide associations within and across Design Control Guidance Elements 1.3. Mange the change process Gestion de los enlaces Gestión de Trazabilidad con Req. Usuario Especificaciones Informes Pruebas reliability statutory and regulatory requirements Traceability Reports: consistency with driving design elements Impact Reports: other design elements affected Links to impacted design elements Traceability Reports: Procedure Attribute Traceability Reports: Milestone Attribute Traceability Reports: Linked design elements Impact Reports: Procedure Attribute Impact Reports: Milestone Attribute Impact Reports: Linked design elements Link Change Design Object with affected design element(s) Traceability Links and Reports from affected design element(s) Impact Links and Reports from affected design element(s) Change Decision Objects with following Attributes: Disposition Attribute Decision Attribute Rationale Attribute Owner Attribute Management Approval Attribute Change Design Object Traceability Link on Procedure Attribute Change Design Object Impacts Link on Procedure Attribute Change Design Object Traceability Link on Milestone Attribute Change Design Object Impacts Link on Milestone Attribute Change Design Object Traceability Link to traced design elements Change Design Object Impacts Link to linked design elements Design Change Module Design Change Reports Object History Object History Reports Versions Baselines Traceability Reports: consistency with driving design elements Impact Reports: other design elements affected Links to impacted design elements Traceability Reports: Procedure Attribute Traceability Reports: Milestone Attribute Traceability Reports: Linked design elements Impact Reports: Procedure Attribute Impact Reports: Milestone Attribute Impact Reports: Linked design elements Link Change Design Object with affected design element(s) Traceability Links and Reports from affected design element(s) Impact Links and Reports from affected design element(s) Change Decision Objects with following Attributes: Disposition Attribute Decision Attribute Rationale Attribute Owner Attribute Management Approval Attribute Change Design Object Traceability Link on Procedure Attribute Change Design Object Impacts Link on Procedure Attribute Change Design Object Traceability Link on Milestone Attribute Change Design Object Impacts Link on Milestone Attribute Change Design Object Traceability Link to traced design elements Change Design Object Impacts Link to linked design elements Design Change Module Design Change Reports Object History Object History Reports Versions Baselines 11

12 Requisitos conducen Desarrollo : Gestión de Requisitos y Trazabilidad ChangeSynergy: Ordenes de Trabajo Ordenes de Trabajo Descomposición en Tareas Ficheros CM Synergy: Tareas Requisitos conducen Desarrollo 12

13 Requisitos conducen Desarrollo Test Tracking Toolkit Para pequeñas aplicaciones de pruebas: Gestión de casos de pruebas en un módulo de Enlaces de requisitos a pruebas Generación automática de ejecuciones de pruebas Comparación de los resultados Comprobación de cobertura completa contra requisitos 13

14 Test Cases Compare Test Runs 14

15 Requirements Test Status Filter on reqs. that have failed/passed Gracias! Preguntas? Puede contactarnos a través de: Antonio Rodríguez Perales antonio.rodriguez@telelogic.com spain@telelogic.com 15