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aligned elements
Aligned AG
World-class Design Control Management will accelerate your Technical File/DHF completion
We are Aligned. Our purpose is to assist our customers to develop innovative Medical Device in less time, using less resources.
Aligned was founded in 2006 by a team of experienced medical device developers with extensive and international background in the Life Science Industry.
Our clients are manufacturers, end-customers and sub-suppliers in the medical device industry, companies who develop and market products which are subjects to regulatory compliance such as FDA Quality Systems Regulations or the EU MDD/MDR and IVDD/IVDR.
Our goal is to enhance our customer's capabilities in how to rapidly and successfully create quality compliant medical devices through excellence in regulatory documentation.
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Jibility
Jibility
Streamline your strategic planning with comprehensive, free resources.
Jibility is a resource designed to assist organizations in developing strategic roadmaps effectively. It is offered at no cost, helping users navigate significant challenges they face in achieving their objectives. This tool is perfect for individuals engaged in strategic planning, whether they're part of a start-up, an established company, or a growing enterprise.
The application guides users through a comprehensive six-step methodology based on capability-driven planning, ultimately producing a straightforward and actionable roadmap. By utilizing an interactive prioritization matrix and capability map, along with a built-in content library and ready-to-use publishing templates, Jibility enables users to efficiently visualize and implement their strategic vision, making the planning process more accessible and organized. This holistic approach not only simplifies roadmap creation but also enhances collaboration among team members.
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Requirements & Test Management for Jira enables you to oversee your entire software development lifecycle, encompassing everything from requirements gathering to production deployment, all within the Atlassian ecosystem. Leveraging the inherent capabilities of Jira, it integrates testing harmoniously with requirements, development tasks, and reporting features. Once the configuration process is finalized, you can quickly dive into managing both requirements and tests. By following six straightforward steps, you can fully harness the testing capabilities offered by Jira.
1. Assess and define requirements.
2. Develop test cases and associate them with Jira tasks.
3. Ensure traceability between requirements and tests.
4. Formulate a test plan and outline its structure.
5. Carry out the test plan and monitor its execution.
6. Review results and make necessary adjustments.
Additional functionalities include:
- Built-in management for requirements
- Hierarchical folder structures for easy navigation
- Reusable templates for test plans
- Basic support for automated testing via REST API
- Customizable dashboards for better visualization
- A traceability matrix along with comprehensive coverage reports and other analytics
- An importer for test cases to facilitate smooth transitions.
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RequirementsHub
SelectHub
Streamline collaboration and enhance efficiency with centralized management.
RequirementsHub is an all-in-one cloud software solution tailored to help businesses effectively oversee their IT and software needs. Developed by Select Hub, this platform aims to enhance operational efficiency by gathering all necessary information in one place, minimizing the confusion caused by excessive meetings, various documents, notes, and emails. Through the use of RequirementsHub, organizations can boost productivity, cut costs, and refine their decision-making processes by systematically gathering, evaluating, and organizing all project-related data and communication within a single hub. This forward-thinking strategy not only makes management tasks more straightforward but also encourages improved teamwork among colleagues. Ultimately, RequirementsHub transforms the way teams collaborate and manage requirements, paving the way for a more organized and efficient workflow.
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SpiraTest
Inflectra
Streamline your software testing with comprehensive quality management solutions.
SpiraTest, created by Inflectra, provides an all-encompassing platform for managing quality assurance and testing activities. It allows software development teams to effectively organize their test cases, requirements, and any identified defects or issues, taking advantage of the platform’s capabilities such as requirements traceability and instant coverage analysis. Moreover, SpiraTest is available in both on-premise and cloud-based versions, catering to different user preferences and organizational requirements. This flexibility not only enhances user experience but also positions SpiraTest as an attractive option for teams aiming to improve their testing methodologies. Consequently, adopting SpiraTest can lead to more efficient and streamlined software development processes.
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iRise
iRise
Empower your team to create stunning prototypes effortlessly.
Swiftly design adaptive websites and mobile prototypes with iRise, an innovative platform tailored for prototyping and wireframing needs. iRise offers a unique combination of prototyping features and requirements management tools, enabling users to create and assess detailed application prototypes. Its notable functionalities include backlog management, story tracking, online review options, real-time documentation, interactive diagrams, and various other resources that foster collaboration and boost productivity. Consequently, this tool becomes indispensable for teams aiming to optimize their design workflows and achieve better project results. By leveraging iRise, organizations can enhance their overall project management and effectively bring their visions to life.
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Orcanos ALM and QMS
Orcanos
Streamline your development process for timely, quality deliveries.
Orcanos provides a robust software solution designed for Application Lifecycle Management (ALM) and Quality Management Systems (QMS), ensuring that products are delivered on time and within budget. This efficient cloud-based platform integrates functionalities such as Requirements Management, Test Management, Document Control, Risk Management, and Quality Management into a single repository. Users benefit from intuitive dashboards and real-time alerts that enhance project monitoring and visibility throughout the development process. The Orcanos e-DMS serves as a comprehensive document management system, enabling users to create, track, search, archive, and approve documentation critical to each stage of medical device launch. By streamlining access to essential documents related to planning, design, development, manufacturing, and servicing, the e-DMS improves the efficiency of quality processes and significantly reduces time to market. Furthermore, this optimized workflow empowers organizations to prioritize innovation and adhere to regulatory standards while maintaining high levels of productivity, ultimately fostering a culture of continuous improvement.
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in-STEP BLUE
microTOOL
Streamline your project management with customizable workflow solutions.
In-STEP BLUE is capable of overseeing various corporate processes, workflows, and standards, including the German V-Modell XT and Automotive SPICE. Activities and artifacts can be customized to fit specific requirements, enhancing flexibility. The software encompasses a range of features, including management of projects, requirements, documents, and resources. Additionally, it allows for risk management through centralized software version modifications utilizing a multi-user Oracle database. To aid in monitoring progress, Gantt charts, dashboards, cost planning, and resource charts are readily available. Furthermore, users can conveniently access progress data, scheduling, and other relevant information remotely through the web application. This versatility makes In-STEP BLUE a valuable tool for organizations looking to optimize their project management processes effectively.
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Codebeamer
PTC
Streamline your product development with comprehensive lifecycle management solutions.
Codebeamer serves as a comprehensive platform for Application Lifecycle Management (ALM), facilitating sophisticated product and software development processes. This open platform not only offers essential ALM features but also supports product line configuration, enabling the tailored management of intricate workflows to suit specific needs.
It empowers teams within the fields of industrial manufacturing and automotive engineering, enhancing the efficiency and quality of complex automotive technology products. By integrating various lifecycle management aspects, Codebeamer covers everything from requirements and risk assessment to thorough test management, ensuring a holistic approach to product development. In doing so, it helps organizations streamline their processes and achieve better project outcomes.
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ReqView
Eccam
Streamline requirements management for optimal product quality assurance.
ReqView is a leading requirements management tool designed to facilitate the management of software, hardware, and systems in accordance with established industry standards such as ISO 29148. It enhances the V-Model approach, ensuring comprehensive traceability and version control with integration options for Git and SVN. Additionally, ReqView seamlessly connects with platforms like Jira and supports ReqIF formats for efficient data handling.
Getting started with ReqView is straightforward; users can quickly import existing documents and then refine their requirements, risks, and testing processes.
The tool allows for customization of requirement attributes to fit specific workflows, enabling users to establish connections between related requirements, verification and validation processes, safety risks, and additional critical factors.
Users can generate traceability reports in various formats, including MS Word, Excel, PDF, and HTML, making it easy to share valuable insights with stakeholders and reviewers.
With ReqView, you can assess the potential impact of changes to avoid unforeseen costs, while also demonstrating that safety risks have been adequately addressed and all requirements have been satisfied. Furthermore, the tool is designed to enhance the overall quality of your product, ensuring that every aspect is meticulously managed and documented.
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An automation system combined with document assembly utilizing 'Plain Text' is straightforward to establish and simple to instruct others on. It offers optional text features along with a variety of strong functionalities to enhance usability. This flexibility makes it suitable for both novice and experienced users alike.
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ManagePro
Angbert Enterprises LLC
Streamline your projects and boost productivity effortlessly today!
ManagePro is an all-in-one software solution designed for effective project and business management, ensuring you stay organized with your daily responsibilities and commitments. This tool simplifies tracking your tasks and deliverables, making it easier to meet your objectives.
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Pearls
Pearls
Streamline your requirements management with unmatched efficiency today!
PEARLS is designed for exceptional user-friendliness and serves as a holistic online solution for managing requirements effectively. It boasts a robust set of tools that make the entire journey of handling requirements seamless, from their inception to their successful completion. This platform simplifies requirement tracking with an intuitive management system that enhances the delegation of tasks among team members, promoting greater efficiency. The advanced five-step project wizard aims to save valuable time for business analysts, significantly boosting their productivity. Moreover, PEARLS centralizes all crucial administrative data in one accessible location, highlighting its organizational capabilities. It also greatly improves the process of defining and managing project use cases, establishing itself as an essential asset. In addition, PEARLS skillfully organizes backlog items alongside user stories, further streamlining the workflow for business analysts. With its innovative features and user-centric design, PEARLS not only fulfills but surpasses user expectations, positioning itself as an indispensable tool in the realm of requirements management. As organizations continue to evolve, PEARLS adapts to meet their growing needs, ensuring long-term success.
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Valispace
Valispace
Streamline engineering workflows, enhance collaboration, and reduce costs.
This platform facilitates teamwork on crucial elements of the Engineering Lifecycle, encompassing:
- Requirements Management
- Data-Driven Functional Design
- Product Architecture
- Comprehensive Systems Design & Simulation
- Automated Verification
- Real-Time Documentation
Additionally, it fosters enhancements throughout the process lifecycle with features such as:
- Agile Engineering Planning
- Technical Change Management
In contrast to traditional siloed Requirement management systems or specialized Model Based Systems Engineering tools, this software's data-centric architecture supports agile hardware design across various departments while maintaining a digital thread throughout the engineering lifecycle. Valispace's unique calculations engine ensures that updates are promptly communicated to users, requirements architecture, verifications, and documentation. By integrating this tool into the engineering workflow, organizations can not only streamline development timelines but also mitigate the risk of costly design mistakes, which can lead to expensive rework and increased expenses. Ultimately, this leads to a more efficient and cost-effective engineering process that enhances overall project success.
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Xebrio
Xebrio
Streamline project success with precise requirements and collaboration.
Defining precise requirements is essential for the success of your products and projects. Rather than creating something entirely new, Xebrio focuses on refining the fundamental aspects of project management, particularly in the realm of requirements management. This platform effectively connects the fluctuating requirements with the ongoing developments of projects.
Xebrio serves as a comprehensive ecosystem that addresses every phase of a project or product's lifecycle, spanning from the initial requirements to the final deployment. By utilizing Xebrio, teams can enhance their productivity and ensure that operations are conducted smoothly and effectively.
With Xebrio, you gain access to an array of tools designed to foster a collaborative atmosphere. This platform optimizes your project management by uniting your team, tools, data, and essential information in one place.
Key Features Include:
1. Requirement Management
2. Task Management
3. Milestone Tracking for Projects
4. Test Coverage
5. Bug Tracking
6. Management of Project Releases
7. Collaborative Document Editing
Additionally, Xebrio's user-friendly interface makes it easier for teams to adapt to changing dynamics and maintain focus on their goals.
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Almware
Almware
Streamline your software projects with innovative requirement management.
Almware is an innovative Software Requirement Management System that aims to enhance and simplify the processes of managing requirements in software development initiatives. Recognizing the critical role that effective requirement management plays in the timely and successful completion of software projects, Almware has been thoughtfully crafted to address these needs.
The system provides a suite of functionalities that encompass requirements management, test management, and seamless integration with source code repositories, ensuring that documentation remains current and all modifications are tracked. By promoting transparency in software development efforts, Almware aids teams in maintaining alignment and encourages open lines of communication among members.
Rather than treating requirements as mere documents, Almware presents them as artifacts, aligning with the best practices outlined in the ISO/IEEE 29148 standards for enhanced clarity and usability. Furthermore, the platform is equipped with a comprehensive array of validation and verification features that significantly bolster the overall quality assurance process in software projects. This holistic approach not only elevates the requirements management experience but also empowers teams to deliver superior software solutions.
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DevSpec
TechExcel
Streamline collaboration, enhance clarity, and drive successful projects.
DevSpec is an innovative platform created for the collaborative oversight of project requirements, allowing users to measure and maintain thorough traceability of these requirements. This tool encourages participation from every stakeholder involved in the project, which helps teams to collectively define and confirm requirements before development begins. Furthermore, DevSpec integrates smoothly with MS Word, leveraging its powerful editing capabilities to improve the documentation workflow. Users gain access to real-time analytics through detailed reporting, which supports informed decision-making at every stage of the project. By enhancing communication and fostering clarity among team members, DevSpec ultimately streamlines the development process and contributes to better project outcomes. This collaborative environment not only boosts productivity but also ensures that all voices are heard and valued throughout the project.
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SILKROAD ALM
NSE Technology
Streamline software development with unparalleled reliability and clarity.
SILKROAD ALM is an all-encompassing application lifecycle management solution tailored for software projects that require exceptional reliability. Drawing its name from the historic "Silk Road," it symbolizes a vast network of trade routes that once connected Asia and Europe. This platform seamlessly integrates numerous legacy management tools, including those for requirements gathering, design, configuration management, and testing, which simplifies the development process for users. Developers often encounter obstacles when trying to produce highly reliable software because of the absence of a centralized tool that oversees the complete development lifecycle, from initial requirements gathering through to testing. SILKROAD addresses this issue by providing a comprehensive perspective on the software development process. The analysis phase consists of a systematic breakdown of requirements elicitation, fostering a more profound understanding of each requirement, and accommodating their representation in various complementary formats. By improving the comprehension and oversight of requirements, SILKROAD ALM significantly boosts the productivity and effectiveness of software development teams, ultimately leading to better outcomes. The system's emphasis on integration and clarity makes it an invaluable asset in the fast-evolving landscape of software development.
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ReqSuite® RM
OSSENO Software GmbH
Streamline your development process with customizable requirements management.
ReqSuite® RM, developed by OSSENO Software, is an ideal solution for forward-thinking mid-sized companies seeking a user-friendly, robust, and fully customizable requirements management tool that can be deployed rapidly. As part of the latest generation of requirements management tools, it is equipped with advanced features to facilitate the oversight of requirements, test cases, risks, standards, architectural components, and various conceptual artifacts throughout the development process. This software offers an extensive suite of tools for collaborative requirements management, encompassing tracking, analysis, approval, review, export, import, and reuse, while also allowing for personalization to suit specific organizational demands. Its user-friendly interface, straightforward installation process, and complimentary premium support ensure that businesses can implement a tailored solution swiftly. By utilizing ReqSuite® RM, companies can enhance the quality of their requirements and streamline their development processes, leading to increased efficiency and uniformity; in fact, organizations may realize savings of up to 30% in overall development effort, significantly benefiting their project timelines and resource allocation. Furthermore, the emphasis on collaboration and adaptability makes ReqSuite® RM a strategic asset for any organization aiming for continuous improvement in their development practices.
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RaQuest
Sparx Systems
Streamline your requirements management for enhanced project success!
RaQuest is a powerful Requirements Management tool specifically developed for the UML modeling software Enterprise Architect (EA), aimed at streamlining the organization of system and application requirements. It provides users with the capability to efficiently track changes to requirements while offering a variety of features for thorough management. This tool is particularly beneficial for enhancing the software development lifecycle of applications. The primary user interface is divided into two key sections: the Project Tree view, which showcases the hierarchy of requirements, and the List view that offers a concise snapshot of Requirement items. All information is securely saved in .EAPX/.EAP files or within the EA Repository, ensuring reliable data preservation. Users can make direct edits to Requirement items in EA, create Use Case elements drawn from existing requirements, and maintain synchronization between them. Furthermore, it enables the generation of Requirements from current Requirement elements as well as pre-existing Use Case components in EA. The Matrix View allows for referencing and modifying the relationships between Requirements and Use Cases, thereby enriching the overall functionality and user experience of the tool. With its extensive features, RaQuest proves to be an indispensable resource for development teams striving to optimize their processes. Its versatility and user-friendly design foster improved collaboration among team members, ultimately benefiting project outcomes.
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REQCHECKER
KHILOGIC
Streamline your documentation for seamless project success today!
Rediscover the ease of document management with REQCHECKER™. This innovative tool is crafted to be unobtrusive, enabling you to preserve your current documents and workflows while enhancing the creation, oversight, and traceability of a variety of documents including specifications, bid proposals, software outlines, system requirements, and quality assurance procedures. By utilizing REQCHECKER™, you can enjoy the benefits of proficient requirements engineering for your initiatives without facing exorbitant expenses. Its automated controls improve both the consistency and clarity of your documentation, making it easily understandable. The features for requirement traceability encompass tracking statuses, quantifying partial coverage, measuring management efficiency, and analyzing overall coverage metrics. With just a simple update of your input documents, REQCHECKER™ identifies essential modifications throughout your paperwork. Moreover, the tool's built-in impact analysis proficiently assesses how any changes to requirements ripple through version management, keeping your project synchronized and current. This seamless integration and functionality render REQCHECKER™ a vital asset for any project team striving for maximum productivity and precision. By adopting REQCHECKER™, teams can ensure that their documentation processes are both streamlined and effective, paving the way for smoother project execution.
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Kytes
Kytes
Effortless integration, exceptional value, and customizable project management.
Kytes PSA is capable of seamless integration with various systems such as ERP, CRM, HRMS, BI, and other custom or third-party applications, ensuring a unified source of truth.
Built on a modern technology stack, Kytes PSA delivers a wide range of thoughtful functionalities, outstanding user experience, and secure, scalable single-tenant cloud hosting. Its extensive configurability simplifies implementation, allowing for quick adaptations to change requests, which helps to optimize both time and costs. Consequently, Kytes PSA stands out as offering exceptional value for its cost compared to global PSA alternatives.
This software supports various project and contract types, including Time & Materials, Fixed Price, Retainership, and Unit Fixed Price, as well as numerous delivery methodologies such as waterfall, agile, and ticket-based approaches.
Moreover, Kytes PSA offers a unique combination of ready-to-use features while also providing customization options, making it ideal for clients aiming to digitize and automate all aspects of their business processes, including customer projects, New Product Development (NPD) initiatives, and internal projects. Ultimately, this versatility allows businesses to enhance their operational efficiency and project management capabilities.
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Reqchoir
Alignd Labs
Unlock seamless collaboration for successful product management today!
A cloud-enabled platform tailored for product teams of varying sizes, it enhances collaboration on requirements, issues, and change management. Navigating product management involves unique challenges as it integrates diverse elements such as product vision, design, development, and sales. This function requires a common language to facilitate clear communication of requirements and priorities among different stakeholders, including executive leadership, sales, and engineering teams. Reqchoir acts as a holistic dashboard that empowers teams across functions to meet this need effectively. As a web and cloud-based tool, Reqchoir enables users to seamlessly capture and manage requirements, issues, and related workflows. With accessibility on laptops, tablets, or mobile devices, teams can improve their processes and elevate product quality through effective collaborative management, ensuring that every team member is aligned and well-informed throughout the lifecycle of the project. This approach not only simplifies the complexities inherent in product development but also fosters an environment of continuous improvement and innovation. By leveraging Reqchoir’s capabilities, teams can adapt more swiftly to changes and drive their products to success.
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Kovair ALM-PLM CoE
Kovair Software
Enhance collaboration, innovate smart products, ensure compliance seamlessly!
Successful collaboration among various functions, diverse enterprise tools, multidisciplinary data, and stakeholders is essential for the simultaneous development of intelligent products. By utilizing an interoperable digital enterprise portal, teams can work together effectively to innovate smart products! This secure integration platform connects intricate tool data, facilitating the creation of competitive offerings. It supports collaboration by enabling the exchange of product development information across different enterprise tools. Additionally, stakeholders can engage in digital design reviews to ensure alignment and quality. To maintain a comprehensive workflow, it is crucial to oversee changes, revisions, and releases in a closed-loop process. Effective management of the Bill of Materials (BOM) throughout the digital thread is also vital. Furthermore, the system accommodates multiple product Variant Configurations, which enhances adaptability. Ultimately, it provides dynamic end-to-end traceability of product development artifacts, significantly contributing to regulatory compliance and fostering innovation in the product lifecycle.
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objectiF RM
microTOOL
Streamline your requirements management with comprehensive, collaborative solutions.
objectiF RM is a robust software solution aimed at effectively managing requirements and facilitating requirements engineering, offering extensive capabilities for the elicitation and analysis of requirements, as well as their modeling, documentation, validation, and verification, all in line with IREB and Business Analysis standards. With UML and SysML modeling features, users can easily illustrate dependencies, relationships, process refinements, and other critical components. Additionally, block diagrams serve as tools for designing system architecture, while real-time generation of requirements specification documents ensures that teams stay up-to-date. To ensure the completeness and accuracy of all requirements, the software allows for thorough reviews and testing procedures. Hierarchical structures are managed through backlogs, and dashboards provide real-time insights into the overall status of requirements. Collaborative efforts are enhanced through objectiF RM's integrated instant messaging and video call capabilities, allowing teams to work together seamlessly, whether on-premise or in the cloud, ultimately fostering a more efficient work environment. This combination of features makes objectiF RM a vital asset for teams aiming to streamline their requirements management processes.