2. IBM Software Group | Rational software
IBM Software Group | Rational software
Архитектура DOORS
47
3. IBM Software Group | Rational software
IBM Software Group | Rational software
DOORS: импорт-экспорт
Direct Entry
Word
MS-Word
PowerPoint
Microsoft
MS-Word RTF Excel
OLE Outlook
HTML
ASCII RTF MS-Word
Spreadsheet ASCII
DOORS
Spreadsheet
MS-Project
MS-Project
Tool Integrations*
Tool Integrations*
Interleaf Interleaf
FrameMaker FrameMaker
Print
48
4. IBM Software Group | Rational software
IBM Software Group | Rational software
DOORS: база данных
Папки
Удаленная папка
Проекты
Документы DOORS
Привычное окружение - легко структурировать проект
49
5. IBM Software Group | Rational software
IBM Software Group | Rational software
DOORS: взгляд на документ
Ничего нового – можно сразу начинать
50
6. IBM Software Group | Rational software
IBM Software Group | Rational software
DOORS: поддержка русского языка
51
7. IBM Software Group | Rational software
IBM Software Group | Rational software
Импорт из Microsoft Word
52
8. IBM Software Group | Rational software
IBM Software Group | Rational software
Окно DOORS
Колонки
атрибутов
Вся информация в одном окне
53
9. IBM Software Group | Rational software
IBM Software Group | Rational software
DOORS: все в одном
Любые данные, в любом формате
54
10. IBM Software Group | Rational software
IBM Software Group | Rational software
DOORS – изменения и связи
Индикатор
изменений
Указатель
связей
Идеально для быcтрого отслеживания изменений
55
11. IBM Software Group | Rational software
IBM Software Group | Rational software
Создание связей – drag-and-drop
как внутри одного документа...
... так и между разными документами
56
12. IBM Software Group | Rational software
IBM Software Group | Rational software
Полная картина
57
13. IBM Software Group | Rational software
IBM Software Group | Rational software
Организация совместной работы
Преодолеть разногласия
между многочисленными
подрядчиками
подразделениями
сотрудниками
?
Привлечь всех к тесной
и организованной
совместной работе
Устранить недоразумения,
связанные с
недостоверностью
информации
58
14. IBM Software Group | Rational software
IBM Software Group | Rational software
Трассировка дает возможности анализа
Требования Технические Дизайн Тестирование
заказчика требования
1. 820.30(b) Design and Development Planning 1. 820.30(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 and development Each manufacturer shall establish and maintain plans that describe or reference the design Identify impacted elements due to a change in another element
1.1. and development 1.1. Identify impacted elements due to a change in another element
activities and define responsibility for implementation. 1. Capture design and related informationand define responsibility for implementation.
activities
• Traceability Reports: consistency with driving design elements
1. Capture design and related information • Traceability Reports: consistency with driving design elements
1.1. Input electronically formatted data
The plans shall identify and describe the interfaces with different groups or activities that provide, or result • Impact Reports: other design elements affected formatted data
1.1. Input electronically
• Impact Reports: other design elements affected
1.2. Reference external information sources identify and describe the interfaces with different groups or activities that provide, or result
The plans shall 1.2. Reference external information sources
in, input to the design and development process. 1.3. Reference external documentation the design and development process.
in, input to • Links to impacted design elements
1.3. Reference external documentation • Links to impacted design elements
1.1.1.Create backward traces to design elements within and across any organizational 1.1.1.Create backward traces to design elements within and across any organizational
The plans shall be reviewed as design and development evolves. 2. Store design and related information shall be reviewed as design and development evolves.
The plans procedure 2. Store design and related information procedure
The plans shall be updated as design and development evolves. 2.1. Identify and tag design information as unique “design design and development evolves.
The plans shall be updated as elements” 2.1. Identify and tag design information as unique “design elements”
The plans shall be approved as design and development evolves. • Traceability Reports: Procedure Attribute • Traceability Reports: Procedure Attribute
2.2. Organize design elements plans shall be approved as design and development evolves.
The 2.2. Organize design elements
2.2.1. Organize by Design Control Guidance Element
1.1.2.Create backward traces to design elements within and across any project milestone
2.2.1. Organize by Design Control Guidance Element
1.1.2.Create backward traces to design elements within and across any project milestone
2. 820.30(c) Design Input 2. 820.30(c) Design Input
2.2.2. Organize by inter-relationships • Traceability Reports: MilestoneOrganize by inter-relationships
2.2.2. Attribute • Traceability Reports: Milestone Attribute
2.1. Each manufacturer shall establish procedures to ensure that the design requirements relating to a 2.3. Ensure all design elements are availablemanufacturer shall establish procedures to ensure that the design requirements relating to backward traces to design elements within and are available
2.1. Each 1.1.3.Create a 2.3. Ensure all design elements across Design Control 1.1.3.Create backward traces to design elements within and across Design Control
device are appropriate and address the intended use of the device, including the needs of the user 2.3.1. Store design elements by Design Control Guidance and address the intended use of the device, including the needs Guidance Elements
device are appropriate Element of the user 2.3.1. Store design elements by Design Control Guidance Element Guidance Elements
and patient. and patient.
2.3.2. Store design elements and their historical values 2.3.2. Store design elements and their historical values
2.2. Each manufacturer shall maintain procedures to ensure that the design requirements relating to a • Traceability Reports: Linked design elements
2.2. Each manufacturer shall maintain procedures to ensure that the design requirements relating to a • Traceability Reports: Linked design elements
device are appropriate and address the intended use of the device, including the needs of the user 3. Manage all user needs device are appropriate and address the intended use of the device, including the1.1.4.Create forward impacts to design elements within and across any organizational
needs of the user 3. Manage all user needs 1.1.4.Create forward impacts to design elements within and across any organizational
and patient. 3.1. Identify the source of the user need patient.
and procedure 3.1. Identify the source of the user need procedure
2.3. The procedures shall include a mechanism for addressing incomplete requirements. 3.2. Identify all user types (groups) The procedures shall include a mechanism for addressing incomplete requirements. • Impact Reports: Procedure Identify all user types (groups)
2.3. 3.2. Attribute
2.4. The procedures shall include a mechanism for addressing ambiguous requirements. 2.4. The procedures shall include a mechanism for addressing ambiguous requirements.
• Impact Reports: Procedure Attribute
3.3. Identify the customer (s) 3.3. Identify the customer (s)
2.5. The procedures shall include a mechanism for addressing conflicting requirements. 3.4. Profile the expected patients 2.5. The procedures shall include a mechanism for addressing conflicting requirements. Create forward impacts to design elements within and across any project milestone
1.1.5.
3.4. Profile the expected patients
1.1.5.Create forward impacts to design elements within and across any project milestone
2.6. The design input requirements shall be documented by a designated individual(s). 2.6. The design input requirements shall be documented by a designated individual(s).
3.5. State the intended use of the product (family) • Impact Reports: Milestone State the intended use of the product (family)
3.5. Attribute • Impact Reports: Milestone Attribute
2.7. The design input requirements shall be reviewed by a designated individual(s). 3.6. Capture the acceptance criteria forThe designneed requirements shall be reviewed by a designated individual(s). 1.1.6.Create forward impacts to design elements within and acrosseach user need
2.7. each user input 3.6. Capture the acceptance criteria for Design Control 1.1.6.Create forward impacts to design elements within and across Design Control
2.8. The design input requirements shall be approved by a designated individual(s). 2.8. The design input requirements shall be approved by a designated individual(s). Guidance Elements Guidance Elements
2.9. The approval, including the date and signature of the individual(s) approving the requirements, 4. Manage design input requirements 2.9. The approval, including the date and signature of the individual(s) approving the requirements,
shall be documented. • Impact Reports: Linked design elements requirements
4. Manage design input • Impact Reports: Linked design elements
4.1. Identify the source of the requirement be documented.
shall
2.10. Questions. 1.2. Associate changed design elements with related elements requirement
4.1. Identify the source of the
1.2. Associate changed design elements with related elements
4.2. Identify the associated user need Questions.
2.10. 4.2. Identify the associated user need
2.10.1. Summarize the manufacturer's written procedure(s) for identification and control of • Link Change Design Object 4.3. Capture requirement description and attributes
2.10.1. Summarize the manufacturer's written procedure(s) for identification and control of
4.3. Capture requirement description and attributes with affected design element(s) • Link Change Design Object with affected design element(s)
design input. 4.4. Capture acceptance criteria design input. • Traceability Links and Reports from affected design element(s)
4.4. Capture acceptance criteria • Traceability Links and Reports from affected design element(s)
2.10.2. From what sources are design inputs sought? 2.10.2. From what sources are design inputs sought?
4.5. Assign responsibility for each requirement
2.10.3. Do design input procedures cover the relevant aspects, such as: (Mark all that apply and • Impact Links and Reports from affected design element(s)requirement
2.10.3. Do design input procedures cover the relevant aspects, such as: (Mark all that apply and
4.5. Assign responsibility for each • Impact Links and Reports from affected design element(s)
4.6. Manage incomplete requirements 4.6. Manage incomplete requirements
list additional aspects.) 4.7. Manage ambiguous requirements list additional aspects.) 1.2.1.Associate design element changes with decisions, rationale, and approval authority
4.7. Manage ambiguous requirements
1.2.1.Associate design element changes with decisions, rationale, and approval authority
2.10.3.1. intended use 4.8. Manage conflicting requirements 2.10.3.1. intended use information 4.8. Manage conflicting requirements information
2.10.3.2. user/patient/clinical 4.9. Approve all requirements 2.10.3.2. user/patient/clinical • Change Decision Objects with following Attributes:
4.9. Approve all requirements • Change Decision Objects with following Attributes:
2.10.3.3. performance characteristics 2.10.3.3. performance characteristics
2.10.3.4. safety 2.10.3.4. safety • Disposition Attribute • Disposition Attribute
5. Manage acceptance 5. Manage acceptance
2.10.3.5. limits and tolerances 5.1. Ensure the acceptance of every user need2.10.3.5. limits and tolerances • Decision Attribute 5.1. Ensure the acceptance of every user need • Decision Attribute
2.10.3.6. risk analysis 2.10.3.6.
5.2. Ensure the acceptance of every design input requirementrisk analysis • Rationale Attribute 5.2. Ensure the acceptance of every design input requirement • Rationale Attribute
2.10.3.7. toxicity and biocompatibility 5.3. Document the results of every user need acceptance test and biocompatibility
2.10.3.7. toxicity
• Owner Attribute 5.3. Document the results of every user need acceptance test • Owner Attribute
2.10.3.8. electromagnetic compatibility (EMC) 5.4. Document the results of every design 2.10.3.8. electromagnetic compatibility (EMC)
input requirements test 5.4. Document the results of every design input requirements test
2.10.3.9. compatibility with accessories/auxiliary devices 2.10.3.9. compatibility with accessories/auxiliary devices • Management Approval Attribute • Management Approval Attribute
5.5. Make acceptance results available 5.5. Make acceptance results available
2.10.3.10. compatibility with the environment of intended use 2.10.3.10. compatibility with the environment of intended use 1.2.2.Provide associations within and across any organizational procedure 1.2.2.Provide associations within and across any organizational procedure
2.10.3.11. human factors 6. Manage change 2.10.3.11. human factors • Change Design Object Traceability Link on Procedure Attribute
6. Manage change • Change Design Object Traceability Link on Procedure Attribute
2.10.3.12. physical/chemical characteristics 2.10.3.12. physical/chemical characteristics
2.10.3.13. labeling/packaging
6.1. Maintain history of design element changes
2.10.3.13. labeling/packaging
• Change Design Object Impacts Link history of design Attribute
6.1. Maintain on Procedure element changes • Change Design Object Impacts Link on Procedure Attribute
6.1.1. Make complete change history available 1.2.3.Provide associations within and across any project milestone available
6.1.1. Make complete change history 1.2.3.Provide associations within and across any project milestone
2.10.3.14. reliability 2.10.3.14. reliability
6.1.2. Maintain history within and across any organizational procedure 6.1.2. Maintain history within and across any organizational procedure
2.10.3.15. statutory and regulatory requirements 6.1.3. Maintain history within and across any project milestone regulatory requirements
2.10.3.15. statutory and • Change Design Object Traceability Link on Milestone Attribute project milestone
6.1.3. Maintain history within and across any • Change Design Object Traceability Link on Milestone Attribute
2.10.3.16. voluntary standards 6.1.4. Maintain history within and across any Design Control standards Elements
2.10.3.16. voluntary Guidance • Change Design Object Impacts Link on Milestone Attribute any Design Control Guidance Elements
6.1.4. Maintain history within and across • Change Design Object Impacts Link on Milestone Attribute
2.10.3.17. manufacturing processes 2.10.3.17. manufacturing processes
6.2. Capture frequency and nature of element changes 1.2.4.Provide associations within and across Design and natureGuidance changes
6.2. Capture frequency Control of element Elements 1.2.4.Provide associations within and across Design Control Guidance Elements
2.10.3.18. sterility 6.2.1. Provide rationale for change 2.10.3.18. sterility
2.10.3.19. MDRs/complaints/failures and other historical data 2.10.3.19. MDRs/complaints/failures and other historical data • Change Design Object Traceability Linkrationale for design elements
6.2.1. Provide to traced change • Change Design Object Traceability Link to traced design elements
6.2.2. Describe decisions made 6.2.2. Describe decisions made
2.10.3.20. design history files (DHFs) 6.2.3. Identify approval authority for the change design history files (DHFs)
2.10.3.20. • Change Design Object Impacts Link to linked design elementschange
6.2.3. Identify approval authority for the • Change Design Object Impacts Link to linked design elements
2.10.4. For the specific design covered, how were the design input requirements identified? 2.10.4. For the specific design covered, how were the design input requirementsMange the change process
6.2.4. Capture date, time, and signature of approving authority 1.3. identified? 6.2.4. Capture date, time, and signature of approving authority 1.3. Mange the change process
2.10.5. For the specific design covered, how were the design input requirements reviewed for 6.3. Identify impacted elements due to a change in the specific design covered, how were the design input requirements reviewed forChange Module
2.10.5. For another element
adequacy? adequacy?
• Design 6.3. Identify impacted elements due to a change in another element • Design Change Module
6.3.1. Create backward traces to design elements within and across any organizational procedure Design Change Reports 6.3.1. Create backward traces to design elements within and across any organizational procedure
• • Design Change Reports
6.3.2. Create backward traces to design elements within and across any project milestone 6.3.2. Create backward traces to design elements within and across any project milestone
• Object History • Object History
• Object History Reports • Object History Reports
• Versions • Versions
• Baselines • Baselines
Реализацию этого
требования как раз
упустили из виду
59
15. IBM Software Group | Rational software
IBM Software Group | Rational software
Виды... Атрибуты...
Практически неограниченное число атрибутов (колонок)
60
16. IBM Software Group | Rational software
IBM Software Group | Rational software
61
17. IBM Software Group | Rational software
IBM Software Group | Rational software
62
18. IBM Software Group | Rational software
IBM Software Group | Rational software
Подозрительные связи
Подозрительные связи (Suspect links) представлены в документе:
либо как индикаторы либо как полное описание
Цепь последовательности никогда не прервется
63
19. IBM Software Group | Rational software
IBM Software Group | Rational software
Трассировка поддерживает целостность набора документов
Если документы связаны …
то изменение, ... отражается в
сделанное в одном виде флага в
документе... другом документе
Может быть организована нотификация исполнителей по e-mail
64
20. IBM Software Group | Rational software
IBM Software Group | Rational software
Система внесения изменений:
Change Proposal System (CPS)
Внесение предложения
на изменение E-mail
К какому требованию ed
e pt
Acc E-mail
Принятие какой причине
По
Предложения других решения ld
пользователей Ho
в режиме on-line On ew i
In Rev
ted
Текущая формулировка
Re jec
Предлагаемая формулировка
Пусть DOORS вместо вас контролирует процесс внесение изменений
65
21. IBM Software Group | Rational software
IBM Software Group | Rational software
Сравнение Baselines модулей, проектов
66
22. IBM Software Group | Rational software
IBM Software Group | Rational software
DWA как альтернатива DOORS Desktop
67
23. IBM Software Group | Rational software
IBM Software Group | Rational software
DOORS Web Access – все для работы
Полный
доступ к базе
Удобные линки
Полная панель
атрибутов
Поиск
Доступ к
дискуссиям
68
24. IBM Software Group | Rational software
IBM Software Group | Rational software
Расширение возможностей Doors
DXL : Doors eXtension Language
Специальные
окна
пользователя
Анализ
Статистика
Подсказка
25. IBM Software Group | Rational software
IBM Software Group | Rational software
Экспорт модели в Rhapsody, Tau, Rose
• Перенос модели в TAU/Architect
• Детализация модели
• Проверка архитектуры и фукционала
• Перенос модели в TAU/Developer
• Детализация модели
DOORS/Analyst • Проверка архитектуры и функционала
• Генерация кода
Traceability
TAU/Architect
Traceability
Application
TAU/Developer
70
26. IBM Software Group | Rational software
IBM Software Group | Rational software
Разработка на основе требований
Предпосылки перехода к Model Driven Architecture
DOORS:
Управление требованиями и трассировка
Rhapsody & Tau:
Визуализация требований и модели
«Привяжите» элементы модели к вашим требованиям
71
27. IBM Software Group | Rational software
IBM Software Group | Rational software
Сравнение результатов тестирования
72
28. IBM Software Group | Rational software
IBM Software Group | Rational software
Тестирование требований (статус реализации)
Фильтр:
результаты
всех тестов
по каждому
требованию
73
29. IBM Software Group | Rational software
IBM Software Group | Rational software
Сравнение результатов тестовых запусков
Наглядность
Понятность
Доступность
74
30. IBM Software Group | Rational software
IBM Software Group | Rational software
Основные преимущества DOORS:
Полная информация по проектам – в любое время, в любом месте
В работе всегда самая последняя редакция любого документа
Возможность контролировать реализацию каждого отдельного
требования и всего проекта в целом
Эффективная работа в коллективе (в т.ч. и с заказчиками):
Работа с единой базой данных
Контроль доступа к информации
Контроль за исполнением на любом этапе (особенно на самых ранних)
Простота внедрения:
с текстом умеет работать все
остальному – научатся
Значительное повышение качества разработок. Проект реализуется:
В нужные сроки
В рамках бюджета
С уверенностью, что каждый пункт задания выполнен
Значительная экономия времени, средств и ресурсов
75
31. IBM Software Group | Rational software
IBM Software Group | Rational software
Rational DOORS решает проблемы наших партнеров…
Телеком Авиация, ВПК Автопром Кораблестроение
76