| 1
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SYS2
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SYS2Search Functionality
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The system shall provide users with the ability to search the repository for relevant knowledge using keywords, categories, or tags.
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functional requirements
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STK1 Knowledge Access
search content
search knowledge
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This requirement addresses the need for Knowledge Access, ensuring that users can easily find relevant information within the repository, thereby meeting the needs of Medical Device Engineers.
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Test
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Test the search functionality with sample queries and verify that relevant knowledge items are returned.
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| 2
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SYS3
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SYS3Regulatory Document Repository
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The system shall include a dedicated section for storing and accessing regulatory standards, guidelines, and documentation.
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functional requirements
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STK2 Regulatory Information
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This requirement fulfills the need for Regulatory Information, ensuring that Regulatory Compliance Officers can easily access relevant regulatory documents, thereby meeting their requirements.
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Inspection
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Review the repository structure and ensure a separate section is available for regulatory documents.
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| 3
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SYS4
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SYS4Quality Assurance Documentation
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The system shall contain templates, protocols, and procedures for quality assurance activities such as validation, verification, and testing.
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functional requirements
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STK3 Quality Management
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This requirement addresses the need for Quality Management, providing Quality Assurance Professionals with the necessary documentation and procedures to ensure the quality of medical devices.
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Inspection
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Review the repository content to ensure it contains relevant quality assurance documentation.
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| 4
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SYS5
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SYS5Research Database Integration
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The system shall integrate with external databases or libraries to provide access to research papers, patents, and emerging technologies
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functional requirements
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STK4 Research and Innovation
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This requirement meets the need for Research and Innovation, enabling Research and Development Teams to access relevant research materials and stay informed about emerging technologies.
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Test
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Test the integration with a sample research database and verify that users can access relevant research materials.
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| 5
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SYS6
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SYS6Clinical Studies Repository
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The system shall include information on clinical studies, user feedback, and usability testing relevant to medical device design.
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functional requirements
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STK5 Clinical Requirements
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This requirement fulfills the need for Clinical Requirements, providing Clinical Specialists with access to information essential for designing safe and effective medical devices.
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Inspection
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Review the repository content to ensure it includes a section dedicated to clinical studies and usability testing reports.
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| 6
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SYS7
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SYS7Market Analysis Reports
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The system shall provide access to market research reports, customer feedback, and competitor analysis.
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functional requirements
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STK6 Market Insights
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This requirement addresses the need for Market Insights, enabling Product Managers to make informed decisions about product development based on market trends and customer feedback.
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Test
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Test access to market analysis reports and verify that users can retrieve relevant market insights.
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| 7
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SYS8
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SYS8Compliance Checklists
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The system shall include compliance checklists and guidelines to ensure medical devices meet regulatory and safety requirements.
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functional requirements
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STK7 Safe and Effective Devices
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This requirement meets the need for Safe and Effective Devices, providing guidance and documentation to ensure compliance with regulations, thereby meeting the requirements of End Users and Regulatory Compliance Officers.
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Inspection
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Review the repository content and confirm the presence of compliance checklists for relevant regulations and standards.
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| 8
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SYS9
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SYS9Administrative Dashboard
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The system shall include an administrative dashboard for managing users, permissions, and monitoring repository usage.
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functional requirements
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STK8 Repository Management
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This requirement fulfills the need for Repository Management, providing Administrators and Decision Makers with the tools they need to oversee and manage the knowledge repository effectively.
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Test
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Test the administrative dashboard functionality and verify that administrators can perform user management tasks and access usage analytics.
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| 9
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SYS10
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SYS10Search Speed
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The search functionality should return results within a maximum response time of 2 seconds.
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non-functional requirements
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STK1 Knowledge Access
search duration constraint=<= 10 seconds
search content
search knowledge
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This requirement ensures efficient Knowledge Access, meeting the needs of Medical Device Engineers who require timely access to information during their work.
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Test
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Measure the response time of the search functionality under various load conditions and verify it meets the specified threshold.
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| 10
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SYS11
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SYS11Concurrent User Support
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The system shall support a minimum of 100 concurrent users without degradation in performance.
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non-functional requirements
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STK1 Knowledge Access
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This requirement addresses the need for Scalability, ensuring that the repository can accommodate the simultaneous access of multiple users, meeting the requirements of Medical Device Engineers and other stakeholders.
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Test
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Perform load testing with simulated concurrent users and verify that performance remains stable.
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| 11
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SYS12
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SYS12User Interface Intuitiveness
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The user interface shall be intuitive and easy to navigate, requiring minimal training for users.
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non-functional requirements
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STK1 Knowledge Access
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This requirement ensures a positive user experience, meeting the needs of all stakeholders who interact with the repository by providing a user-friendly interface.
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Test
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Conduct user testing with a sample group of users and gather feedback on the ease of use of the interface.
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| 12
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SYS13
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SYS13Role-based Access Control
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The system shall implement role-based access control to ensure users only have access to information relevant to their roles.
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non-functional requirements
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STK8 Repository Management
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This requirement addresses the need for Security, ensuring that sensitive information is protected and only accessible to authorized users, meeting the requirements of all stakeholders who rely on the repository for information.
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Inspection
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Review the access control settings and verify that users can only access information based on their assigned roles.
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| 13
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SYS14
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SYS14System Uptime
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The system shall have a minimum uptime of 99.9% over a one-month period.
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non-functional requirements
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STK8 Repository Management
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This requirement ensures continuous access to the repository, meeting the needs of all stakeholders who depend on it for access to critical information and resources.
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Analysis
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Monitor system uptime using monitoring tools and verify that it meets the specified uptime requirement.
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| 14
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SYS15
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SYS15Content Support
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The system shall support content: articles, videos, interactive content, images.
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functional requirements
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STK9 Content Type
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Demonstration
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