Alternatives to Polarion REQUIREMENTS

Interfacing’s Integrated Management System (IMS ) is an AI-supported platform that brings BPM, QMS, Document Control, and GRC together in one environment. Teams use IMS to design and manage processes, govern documentation, oversee risks, and demonstrate compliance with complete visibility and reliable audit evidence. Built for sectors that depend on strict oversight, such as aerospace, life sciences, public sector, and financial services, IMS offers real-time monitoring, automated workflows, and AI-driven analytics that strengthen quality and lower operational exposure. The system is ISO 27001 certified and validated for 21 CFR Part 11, ensuring secure and compliant use in regulated operations. IMS also provides low-code automation, process mining, audit tools, training management, CAPA workflows, and dashboards that help organizations improve performance and maintain regulatory control. AI enhances governance, improves precision, and supports continuous compliance.

Process Street is the Compliance Operations Platform built for teams that need to move fast without breaking standards. It combines document control, workflow automation, and AI-powered oversight in a single system so every policy is followed, every step is tracked, and every audit is effortless. Unlike legacy GRC tools or static SOP docs, Process Street turns compliance into a living system. Policies are documented in governed, version-controlled Pages. Those policies are executed through dynamic workflows with built-in task assignment, approvals, and forms. Every action is logged, monitored, and optimized in real time by Cora, our AI compliance agent. Used across industries like financial services, real estate, healthcare, and manufacturing, Process Street helps teams automate employee onboarding, streamline audits, manage policy updates, enforce vendor reviews, and run critical processes at scale. No code required. No micromanagement. Just proof that work gets done right, every time. Companies like Salesforce, Colliers, Drift, and Hartford Healthcare trust Process Street to eliminate busywork, improve operational visibility, and reduce compliance risk across the business. With native integrations, role-based access, audit trails, and ISO-aligned workflows, it is the platform that makes compliance a competitive advantage. From onboarding to audits, Process Street is how high-stakes teams enforce standards, automate execution, and prove compliance by default.

Jama Connect®, a product development platform, uniquely creates Living Requirements™. This digital thread is created through siloed, test, and risk activities to provide end to end compliance, risk mitigation, process improvement, and compliance. Companies creating complex products, systems, and software can now define, align, and execute on what they need. This reduces the time and effort required to prove compliance and saves on rework. You can be sure of success by choosing a solution that is easy-to-use, flexible, and offers support and services that are adoption-oriented.

Streamline every stage of the development lifecycle with a flexible solution built for SxMD. Efficiently manage design controls from requirements to compliance with end-to-end traceability to mitigate risk. Innovate faster with a flexible item-based approach to documentation designed to meet even the most complex SxMD product needs. Enhance quality management with full traceability from design input to output with a purpose-built software platform that enables a collaborative quality culture across all teams. Take charge of evolving design, quality, and regulatory requirements while empowering team autonomy and get your product on the front line faster. Ensure frictionless alignment between platforms with native integrations for Jira, GitLab, GitHub, Azure DevOps and more. Leverage our REST API to connect with all your tools.

Modern Requirements4DevOps is Microsoft's preferred partner for requirements management. It transforms Azure DevOps to a full-featured Requirements Management Tool. Your teams can come together on one platform to create a single source of truth model. Requirements are stored in the same place that your Test Cases or Code Repositories. Our tool supports agile, waterfall, and hybrid requirements by bringing reviews, end-to-end traceability, reporting, elaboration, modelling and more to Azure DevOps. Our robust requirements solution includes a leading feature set with project auditability.

Kualitee, a test management tool, is a complete ALM alternative to agile QA and Dev teams. It allows you to plan, write, execute, and track software tests in a collaborative environment. The tool allows for easy reuse of test cases from repository and tracks testing activities with complete traceability. Teams can manage multiple types of testing from one location, including functional, cross-browser, and automation. Kualitee has many popular features, including a built-in defect management module and on-premise and cloud versions, requirement management, as well as a mobile app. Kualitee can be integrated with many other tools, such as Jira and GitLab.

ScopeMaster automates the analysis of software requirements and user stories. ScopeMaster uses natural language processing (a branch AI) to perform requirements analysis work in seconds. This includes comprehensive defect detection, functional testing creation and functional sizing. Q.A. User story ScopeMaster can identify up to 9 types of potential defects in requirements. Sizing user stories. ScopeMaster automatically sizes user story in COSMIC function point and IFPUG function point. ScopeMaster creates functional tests. ScopeMaster generates positive and negative test scenarios that can be traced back to the functional intent of the requirements. There is native synchronisation with Jira Cloud and Azure devOps. Included is a REST API for integration with other tools.

Teamcenter® software represents a contemporary and flexible product lifecycle management (PLM) solution that integrates individuals and workflows across various functional areas through a cohesive digital thread that fosters innovation. Its extensive and diverse portfolio empowers organizations to tackle the complex challenges associated with creating highly successful products. With a user-friendly interface that is both simple and intuitive, Teamcenter enables team members from all corners of the organization to engage in the product development journey more seamlessly than ever. Regardless of your deployment preference—whether on-premises, in the cloud, or via the SaaS option Teamcenter X—you will access the same reliable capabilities that are tailored to accelerate your innovation. Begin your journey with Teamcenter by managing product data and processes, encompassing 3D designs, electronics, embedded software, documentation, and your bill of materials (BOM). By utilizing your product information across a wider range of domains and departments, you can achieve significantly improved returns on your PLM investment. Ultimately, Teamcenter not only streamlines operations but also enhances collaboration, making it an essential tool for modern product development.

Visure Solutions, Inc., a leading provider in requirements management tool suites, offers a comprehensive collaborative ALM Platform to system engineering industries. Visure's value proposition includes the complete innovative technology in key functions: standard compliance with safety-critical and business critical systems. - Traceability and Requirements Management - Test Management - Issue and Bug Tracking - Risk Management - Collaboration Management - Centralized data base, Review/Approval process - Certification Management (Support for many Standard Templates ISO26262, IEC62304 and IEC61508, CENELEC50128), DO178/C FMEA, SPICE, CMMI, CENELEC50128, CENELEC50128, DO178/C. + Tool Qualification Package - Configuration Management, Baselining and History Tracking, Requirements versioning - Dashboards + Report Customization - Integrated with DOORS and Jama, Siemens Polarion. PTC, Perforce. JIRA. Enterprise Architect. HP ALM. Microfocus ALM. PTC. TFS. Word, Excel. Test RT, RTRT. VectorCAST. LDRA.

ReqSuite® RM (from OSSENO Software) is the right choice for innovative (mid-sized) companies that want to benefit from an easy-to-use, powerful, 100% customizable, and quickly deployable requirements management tool. It belongs to the newest generation of RM tools and therefore includes powerful features for managing requirements, test cases, risks, standards, architectural elements, and other conceptual artifacts along the development cycle. The software provides a comprehensive toolkit for collaborative requirements management, tracking, analysis, approval, review, export, import, and reuse, as well as customization of the tool to meet individual needs. Additionally, its ease of use and simple set-up, as well as free premium support means you can get a customized solution quickly running. With ReqSuite® RM, organizations increase the quality of requirements, and achieve higher efficiency, ease and standardization in their development processes. Savings up to 30% of the total development effort are possible.

IBM Engineering Requirements Management DOORS Next offers a versatile platform designed to enhance communication and cooperation between teams and stakeholders, ultimately leading to increased productivity and quality outcomes. This solution allows users to effectively capture, trace, analyze, and manage modifications to requirements while ensuring adherence to relevant regulations and standards. By utilizing DOORS Next, organizations can enhance their ability to manage project scope and costs across their operations and supply chain. With deployment options available both on-premises and in the cloud, users can choose the setup that best suits their specific environment. Furthermore, the software promotes greater efficiency through advanced version and variant management features, while also fostering collaboration within diverse, multidisciplinary teams. Leveraging AI capabilities, such as the Requirements Quality Assistant, allows for further refinement of requirements, ensuring that users have the most effective tools at their disposal for comprehensive requirements management. Ultimately, this approach not only enhances transparency and minimizes rework but also significantly boosts the reusability of project components. Through these features, organizations can expect to achieve a more streamlined and efficient workflow.

Requirements & Test Management for Jira allows you to manage your entire software project, from requirements to production, right within the Atlassian suite. It is built on Jira native functionality that seamlessly integrates testing with requirements, development and reporting. After configuration is complete, you can immediately start managing requirements and testing. In 6 steps, you can unleash the full testing potential of Jira. 1. Analyze and create requirements. 2. Write test cases and link them with Jira. 3. 3. Verify the traceability. 4. Create a test plan and design it. 5. Execute the test plan and track its execution. 6. 6. Other features: Management of requirements built in - Tree folder structures and navigation module - reusable Test Plan templates, - Basic automated testing support (RESTAP), - configurable dashboards, - Traceability matrix, full coverage requirements and other reports - test case importer

Requirements Portal by Altium is a requirements management and verification tool integrated directly into Altium’s solutions, including Altium Develop, Altium Agile Teams and Altium Agile Enterprise. It enables engineering teams developing hardware products and embedded systems to create, store, and manage formalized requirements and link them to designs and verification data. Each requirement is traceable and connected to upstream system definitions and downstream design and verification artifacts, such as schematics, PCB layouts, BOMs, and test cases, providing visibility from system design through implementation, verification, handoff, and certification. This helps teams reduce rework, avoid misalignment across disciplines, and simplify compliance activities. — Why choose Requirements Portal? Unlike traditional requirements management systems that are rigid, expensive and maintained by dedicated admins, Requirements Portal offers an easy-to-use and easy-to-learn alternative that delivers a fast return on investment for engineering teams. Compared to document-based approaches that are near-impossible to scale beyond a few hundred requirements, Requirements Portal helps you scale across complex products and multiple projects with thousands of requirements. — Requirements Portal is the successor to Valispace, created after Altium acquired the company and integrated its technology into the Altium ecosystem. Requirements Portal is included in Altium Develop, and the starting price includes unlimited collaborators.

Effective collaboration across multiple functions, disparate enterprise tools, multidisciplinary data, and stakeholders is key to developing smart products simultaneously. Connect through an interoperable digital enterprise portal to create smart products! Secure integration platform connecting complex tools data for developing competitive products. To collaborate, exchange product development data across multiple enterprise tools. To conduct digital design reviews with stakeholders. For a closed loop process, manage changes, revisions, and releases! To manage Bill of Materials (BOM), across the digital thread. To handle multiple product Variant Configurations. To allow dynamic end-to-end traceability of product development artifacts, which aids regulatory compliance.

The Capella publication offers seamless integration between the Eclipse Capella modeling environment and various Requirements Management Systems that adhere to the OSLC-AM specification, such as Polarion and Doors Next. This integration significantly enhances engineers' productivity by allowing meticulous traceability between system requirements and design elements. By keeping the system model and requirements aligned, it helps prevent errors and ensures that consistency is maintained between the requirements in your management tool and the architecture in Capella. With the convenient drag-and-drop feature, users can easily incorporate requirements into Capella, fostering improved communication and collaboration among engineering teams. By breaking down barriers between teams, this integration provides online access to system architecture, enabling the effective reuse of requirements and system components. Ultimately, this creates a single source of truth, ensuring digital continuity where system designs and requirements are developed using optimal tools and are readily accessible. Furthermore, this cohesive approach streamlines project workflows, enhancing overall project outcomes and team synergy.

Dimensions RM allows you to easily manage requirements reuse, variant management and requirements branching/merging. This will allow you to meet today's product design challenges. Coordinate requirements definition and approvals with all stakeholders. Manage complex projects, dispersed development teams, multiple releases, and change efficiently. Dimensions RM supports both traditional and agile requirements management. It also offers a sweet spot for hybrid approaches that integrate both the best of both worlds and provide traceability. Dimensions RM was designed to allow organizations working in highly regulated or complex industries to reuse requirements without compromising audit trackability. Dimensions RM provides real end-to-end traceability of complex development projects through its requirements process support and integrations. It is easy to view requirements relationships, changes, or dependencies using wizard-driven reporting.

Facilitate both internal and external stakeholders in reviewing and commenting on work items while ensuring compliance with industry standards for electronic signatures and approvals. By granting access to relevant contextual information, the process of external review and approval by partners, suppliers, and customers becomes significantly streamlined. Project administrators have the capability to allocate review access with precision, maintaining the same level of security, permissions, and visibility available across all Polarion solutions. Additionally, reviewer rights can be activated based on project-specific or global workflow requirements, making it highly beneficial for partners, suppliers, customers, and managers who need to validate task completions. Polarion Reviewer also caters to CFOs who require approval regarding financial implications. Our solutions empower organizations of varying sizes to create and utilize digital twins, which offer valuable insights, uncover new opportunities, and enhance automation to foster innovation. This comprehensive approach not only boosts operational efficiency but also strengthens collaboration among all stakeholders involved.

Experience simplicity once again with REQCHECKER™. This tool is designed to be non-intrusive, allowing you to maintain your existing documents and workflows while facilitating the writing, management, and traceability of various documents such as specifications, bid submissions, software, system specifications, and quality processes. With REQCHECKER™, you can reap the advantages of effective requirements engineering for your projects without incurring high costs. The automatic controls enhance both consistency and readability, ensuring that your documentation is clear and accessible. Requirement traceability features include tracking statuses, measuring quantifiable partial coverage, assessing management rates, and evaluating overall coverage rates. By simply updating your input documents, REQCHECKER™ highlights necessary changes across your documents. Furthermore, the tool's automatic impact analysis effectively evaluates how all requirement modifications propagate through version management, ensuring that your project remains aligned and up to date. This seamless integration makes REQCHECKER™ an indispensable asset for any project team aiming for optimal efficiency.

An effective ALM tool significantly enhances the management of your product's application lifecycle. The premier ALM tools offer comprehensive traceability throughout the entire lifecycle, which is why development teams from various sectors opt for Perforce ALM (formerly Helix ALM). This versatile suite of ALM tools is designed to facilitate the tracking of requirements, testing, and issue management. Perforce ALM stands out as the top software for application lifecycle management, providing extensive traceability throughout the process. This means you will have clear visibility into whether requirements have been adequately tested and fulfilled, whether test executions were successful or not, and whether any issues have been addressed. Furthermore, should a requirement undergo changes, you will instantly know the test cases and issues that may be affected. Perforce ALM simplifies the creation of requirements and the sharing of related documents, allowing for seamless reviews and approvals directly within the application. Additionally, it offers the flexibility to reuse requirements across different projects, enhancing efficiency and collaboration. The collaborative features of Perforce ALM ensure that all team members stay informed and aligned throughout the lifecycle.

IBM Engineering Lifecycle Management (ELM) serves as a cutting-edge, all-inclusive engineering solution, effectively guiding users through every stage from requirements gathering to systems design, workflow, and testing management, while enhancing the capabilities of ALM tools to support intricate systems development. By embracing a holistic perspective throughout the product lifecycle and establishing a robust digital infrastructure for data traceability, organizations can efficiently monitor changes, thereby mitigating risks and lowering expenses. Tackle the intricacies of engineering from conceptual design to final execution, foster collaboration among teams through a cohesive digital thread, utilize modeling and reuse strategies, capitalize on insights derived from automated reporting, and confidently scale operations to create a robust foundation for continuous innovation. The interlinked data within the digital thread will provide a unified source of truth, empowering functional, software, mechanical, and electrical engineering disciplines to work in harmony. This interconnected approach not only streamlines processes but also enhances the overall efficiency and effectiveness of the engineering lifecycle.

Storywise is an innovative platform that leverages artificial intelligence to enhance the requirements engineering process for software development, making it easier to create, manage, and transition software specifications, user stories, and Software Requirements Specifications (SRS) documents. It facilitates the conversion of raw materials like meeting notes, mock-ups, and unstructured descriptions into organized epics, defined personas, user stories, and acceptance criteria, ensuring comprehensive traceability from the initial input to the finished product. The platform features a user-friendly wizard-based workflow, an AI chat assistant, and robust tools for version and change management, along with seamless integration with various applications such as Jira, Azure DevOps, YouTrack, Figma, and Zapier. Additionally, it provides options for exporting documents to Word or PDF formats, allows for the organization of optional features to generate tailored quotes, and supports a hybrid approach to agile and fixed-price workflows, effectively minimizing scope misunderstandings and optimizing documentation processes. By harnessing AI to automate the more tedious aspects of structuring requirements, development teams, consultants, agencies, and procurement professionals can significantly enhance their productivity and focus on more strategic tasks. This results in a more efficient workflow that ultimately leads to faster project delivery and improved overall quality in software development.

ReqView is an industry standard requirements management tool that allows SW, HW, and Systems (such as ISO 29148) to be managed in compliance with industry standards. It supports V-Model, end-to-end tracability, and version control in Git/SVN. It integrates with Jira, ReqIF and ReqIF. ReqView allows you to get started quickly. Import your documents, then elaborate on requirements, risks and tests. Customize the attributes of requirements according to your workflow. Link related requirements to verification & Validation, safety risks, and other factors. Create traceability reports in MS Word, Excel PDF or HTML formats, and share them with reviewers. Estimate the impact of changes in order to avoid unexpected costs. Prove that safety risks have been mitigated and that all requirements are met. Improve the overall quality of your product.

Reqode, a new Software Requirement Management System, is designed to streamline and improve the requirements management processes of software development projects. It was designed with the understanding of the importance of effective requirement management for the successful delivery and completion of any software project. Reqode offers functionalities for requirements management, test management, and integration with source code repositories. This allows documentation to be kept up-to-date and changes to be captured. Reqode brings clarity to software development projects, helps teams stay aligned and fosters clear communication. Reqode represents requirements as artifacts and not documents (like in a classic requirement management system). This approach was based on ISO/IEEE 29148 standard best practices. Reqode offers a wide range of validation and verification capabilities.

In-STEP BLUE can manage corporate processes, workflows, or standards such as the German V-Modell XT or Automotive SPICE. You can tailor activities and artifacts according to your needs. The software features include project, requirements, document and resource management. You can also manage risk by modifying the version of the software from a central, multi-user Oracle database. Gantt-Charts and dashboards as well as cost planning and resource charts are all available to facilitate tracking progress. Remote access to progress data, scheduling, and other information is possible via the webapp.

ReqXChanger facilitates two-way traceability that adheres to the ReqIF standard, connecting requirements management systems with UML/SysML modeling platforms. This tool allows users to export requirements in ReqIF format from their RM system, transforming them into UML-compatible components within their modeling software, and also supports the reverse process, enabling the import of model information back into the requirements environment for better visualization of implementation coverage and effective impact analysis. Additionally, it monitors changes to linked requirements and highlights related model elements as “Suspect Links” for further examination, which aids in preventing potential miscommunications or design inconsistencies. By ensuring transparency throughout the process, it provides comprehensive visibility of coverage, encourages data synchronization between RM and modeling tools, and enhances the regulated migration or reuse of engineering assets, thereby simplifying compliance procedures. Moreover, ReqXChanger enhances efficiency by offering automation capabilities through CLI scripting, which streamlines routine tasks such as export, import, and synchronization processes while maximizing productivity. The comprehensive features provided by ReqXChanger ultimately contribute to a more cohesive and organized approach to managing both requirements and models.

You can manage your needs, epics and user stories through a series sprints. Each sprint uses your choice of requirements management, model-based systems engineering (MBSE), and test management. You can also choose to use formal change control, configuration management, and change tracking. Cradle®, our requirements management and systems engineering software tool, integrates your entire project lifecycle into one, highly scalable, integrated, multiuser product. Cradle can handle all your requirements management, model driven, defect tracking, and test management needs, no matter how small or large your projects may be. Cradle's unrivaled feature list, flexibility, simplicity, and low cost make it the perfect choice for anyone new to agile methods, systems engineering, or requirements management.

SILKROAD ALM serves as a comprehensive application lifecycle management system specifically designed for software that demands high reliability. Its name, inspired by the historical “Silk Road,” reflects a network of interconnected trade routes spanning Asia and Europe. This system integrates various legacy management tools including those for requirements, design, configuration management, and testing, allowing for seamless navigation through the development process. Many developers face challenges in creating highly reliable software due to the lack of a unified tool that oversees the entire development lifecycle from initial requirements to testing phases. SILKROAD aims to address this gap by offering a holistic view of the software development journey. The process of analysis consists of a methodical decomposition stemming from the elicitation of requirements, which leads to a deeper and clearer comprehension of each requirement while allowing for the representation of these requirements in diverse and complementary formats. By facilitating better understanding and management of requirements, SILKROAD ALM can significantly enhance the efficiency and effectiveness of software development teams.

Enterprise software to improve business agility. objectiF RPM features include portfolio, requirements, test and risk management. UML/SysML diagrams allow you to visualize requirements, goals, and processes. You can also manage backlogs at different levels (from business use case, user story), plan taskmanagement with Kanban boards and run queries across multiple projects. This allows you to collaborate with distributed teams using one source of information. The software can be customized to meet your corporate needs. It is flexible, extensible, and integrable. It provides templates for agile and mixed project management, digitization programs, and projects following Scaled Agile Framework®, SAFe.

DevSpec is a tool designed for collaborative management of requirements, empowering users to quantify and ensure complete traceability of those requirements. This platform facilitates input from all project stakeholders, enabling the team to collaboratively establish and finalize requirements prior to the start of development. Additionally, DevSpec offers seamless integration with MS Word, making use of its robust editing features to enhance the documentation process. Users can also access real-time insights through comprehensive reporting, which aids in informed decision-making throughout the project lifecycle. Ultimately, DevSpec enhances communication and clarity among team members, fostering a more efficient development process.

Enhance collaboration among teams and streamline project management by utilizing a cohesive solution for requirements gathering, coding, testing, and release processes. In traditional software development settings, various fragmented tools are often employed to oversee the application lifecycle, leading to disorganized development assets. This disorganization can impede teamwork, reduce clarity, compromise system integrity, and obstruct innovation. Polarion ALM offers a comprehensive solution that promotes project transparency by providing real-time, consolidated management insights. This ensures that all team members understand the objectives of their work, fostering alignment and facilitating progress while safeguarding both integrity and compliance. With this unified approach, teams can react more swiftly and efficiently to emerging business opportunities and evolving customer expectations. Furthermore, this solution enables seamless collaboration among all stakeholders by offering 100% browser-based access to a centralized data repository, enhancing overall productivity and effectiveness.

Kovair ALM is a cohesive and user-friendly platform that streamlines Application Lifecycle Management (ALM) across various stages such as Project Management, Requirements Management, Development, and Testing & Quality Assurance. Equipped with features like comprehensive traceability and real-time analytics derived from all lifecycle phases, Kovair ALM serves as a definitive reference point for all stakeholders engaged throughout the process. Additionally, its task-oriented workflows, along with customizable notifications and business rules, empower organizations to establish and maintain centralized governance throughout each project phase. This integration helps to eliminate unnecessary manual transitions between teams, reduces costs, automates processes across different lifecycle stages, and improves product quality by ensuring adherence to a range of industry standards. By leveraging its extensive capabilities, Kovair ALM positions itself as a valuable asset for organizations aiming to enhance their ALM practices. Exploring the platform's value propositions can provide deeper insights into its benefits.

SpiraTest, developed by Inflectra, offers a comprehensive solution for quality assurance and test management. It enables software teams to efficiently handle their test cases, requirements, and any defects or bugs, all while benefiting from the platform's features like requirements traceability and real-time coverage analysis. Additionally, SpiraTest is accessible in both on-premise and cloud-based formats, accommodating various user preferences and organizational needs. This versatility makes it an appealing choice for teams looking to enhance their testing processes.

IRIS Business Architect stands out as more than just another enterprise architecture tool; it is primarily a collaborative software application designed with a focus on business-centric planning, encompassing elements like business design, transformation architecture, project and initiative planning, as well as agile delivery tailored for an organization's complete planning ecosystem. Typically, this tool is managed by the Business Transformation Committee rather than being solely the responsibility of the CIO. As organizations face the pressing challenge of digital transformation, the ability to deliver agile business architecture has emerged as a crucial skill. Achieving this level of agility is often a struggle for traditional enterprise architecture approaches, which may not adapt swiftly to the demands of modern business environments. While it is imperative to plan and establish architectural concepts in advance, the methodology for doing so needs to evolve. According to a whitepaper authored by Daniel Lambert, effective product management plays a pivotal role in driving a customer-focused transformation within businesses. Emphasizing a shift in perspective can greatly enhance the overall outcome of transformation initiatives.

TraceCloud stands out as the leading requirements management and traceability solution available today. Whether accessed through the cloud or installed on-site, it empowers organizations to work together effectively, articulate, oversee, and fulfill the needs of their clients. Among its key features are a comprehensive system that integrates defect tracking, requirements, and test management, robust two-way compatibility with Excel and Word, along with an internal change control board and approval workflow system. This platform not only streamlines processes but also enhances overall project visibility and accountability.

Aligned provides Aligned Elements, an ALM system to ensure compliant development documentation for regulated products in the Medical Device Industry. We assist our clients in developing, manufacture and market regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. At Aligned, we believe that management of product and project documentation of regulatory compliant products shall be efficient and pragmatic. We advocate an approach that allows your development team to focus on innovation instead of administration. We strive to build value that last and therefore stay deeply involved with the undertakings of our clients until we are sure that sustainable results are achieved.

Effortlessly capture software requirements and use cases while automating the generation of requirements documents. The Roadmap provides a structured method for efficiently collecting a comprehensive set of requirements, ensuring you always know your next steps. This agile requirements management tool is favored by Business Analysts for its effectiveness. You can begin using it in just a few minutes, allowing you to start documenting requirements quickly, and you will also gain access to our complimentary online course. Additionally, this streamlined process empowers teams to enhance collaboration and productivity significantly.

Rapidly create responsive websites and mobile prototypes using iRise, a cutting-edge platform designed for prototyping and wireframing. iRise provides a distinctive blend of prototyping capabilities and requirements management tools, allowing users to develop and evaluate high-fidelity application prototypes. Among its standout features are backlog management, story tracking, online review functionalities, real-time documentation, interactive diagrams, and additional resources that enhance collaboration and efficiency. This makes it an essential tool for teams seeking to streamline their design processes and improve project outcomes.

In the role of a project manager or business systems analyst, it is standard practice to convene with a project team to finalize and secure agreement on project requirements. Nevertheless, it often occurs that clients introduce additional features that fall outside the agreed-upon scope detailed in the current requirements documentation. This situation, commonly referred to as "scope creep" or "feature creep," poses a significant risk to the success of the project, making it essential for project managers to adeptly navigate these challenges when they arise. To effectively recognize scope creep, having a comprehensive understanding of the initial requirements is crucial. It is advisable to maintain a well-organized requirements management document that encompasses a mission statement, a background statement addressing needs, an overview of high-level features, and as many specific requirements as possible, all of which should align with the identified features. By creating a detailed and extensive set of requirements, you establish a clear baseline for the system’s functionalities, which can often help to prevent or at least lessen the impact of scope creep right from the start. Additionally, regular communication with stakeholders can further ensure that everyone remains aligned on project goals and expectations, minimizing the likelihood of unexpected changes.

Cockpit Enterprise, our software application for medium-sized to large medical device product developers, integrates requirements management and test management in a single environment. Cockpit Enterprise can be customized to meet the needs of any company. It offers a rich development environment that allows organizations to implement Standard Operating Procedures (SOPs), and Work Instructions(WIs) in a controlled, auditable environment. Cockpit Enterprise is a tool that helps medical device manufacturers of Class II or III devices to author, review, and approve documents necessary for regulatory submissions. Cockpit Enterprise is best for mature companies that have established standard operating procedures, and can devote the necessary resources to configuring the system and deploying it.

Conversations, brainstorming, and teamwork occur seamlessly within a document environment. Every interaction is recorded and can be revisited at any moment with clarity. Kloud meetings allow participants to share documents alongside their screen without the need for video streaming, ensuring high performance at lower costs. Unlike traditional screen sharing, LiveDocs breathes life into your documents, enabling features like annotations, voice recordings, and video embeds for enhanced presentations. This dynamic approach to collaboration captivates your audience effectively. With both private and public workspaces tailored to your needs, teams can engage in interactive, secure, and straightforward collaboration. Kloud offers tools like LiveDocs, Calendar, SyncRooms, and Meetings, along with integrations such as P1 Jira and others. As we transition into the digital age, Kloud empowers teams to elevate their collaboration and communication efforts. LiveDocs further enhances meeting experiences by incorporating engaging elements like annotations, synchronized voice, and video content, making every session memorable and impactful.

P4 Plan (formerly Hansoft) serves as a dynamic project management and planning solution aimed at fostering teamwork and collaboration among different teams, while offering the versatility to manage projects using various methodologies including SAFe, Scrum, and Kanban. This tool enables teams to monitor their tasks, time, and overall progress in real-time, delivering extensive visibility along with sophisticated features like capacity planning and historical project data. It seamlessly integrates with existing systems and tools, such as P4 and Perforce ALM, to enhance traceability and streamline operations. Designed with a user-friendly interface that can be customized to fit the needs of individual teams, Helix Plan not only speeds up planning and decision-making processes but also promotes quicker delivery and improved efficiency for development teams, ultimately leading to more successful project outcomes. By supporting diverse methodologies and ensuring adaptability, it becomes an invaluable asset for organizations aiming to optimize their project management efforts.

Reqtest enables you to quality assure all of your IT projects and release new software with full confidence. Within the platform you can easily manage requirements, perform extensive testing and track bugs. Managing the scope, quality, & progress of your IT projects have never been easier. – Collaborate with suppliers and within the organization – Integrate with Jira, DevOps or other tools – Track the project progress with your own dashboards

Compile and organize Action Items that stem from compliance mandates, audit results, incidents, and other occurrences, while offering real-time insights into compliance levels and EHS performance metrics. The Completion Scorecards enable site leaders to assess their team's effectiveness and pinpoint which positions are heavily burdened with work. By utilizing interactive dashboards and filters, Corporate EHS leaders can analyze trends and uncover compliance deficiencies across various facilities and regulatory sectors. Customized regulatory profiles for each site ensure that compliance strategies are consistently precise and current. Compliance Calendars and dashboards outline both completed tasks and upcoming deadlines, and task details provide information on any changes to related regulations. The Action Items feature includes connections to pertinent citations, audit inquiries, and event specifics, creating a reliable knowledge repository that delivers context for your teams. Furthermore, email alerts keep accountable individuals updated, while event logs meticulously track all modifications, making it evident who executed each action. This comprehensive approach not only enhances accountability but also fosters a culture of continuous improvement in compliance and performance management.

NewSysRS is an online platform designed for comprehensive project and requirements management, catering to a diverse range of businesses. It offers customizable solutions including specifications, task manager work items, and adaptable dashboards tailored to meet specific organizational needs. Users can define unique attributes, create custom views, and establish various types of specifications and task manager work items, as well as outline workflows for these work items. The platform enables linking between different task manager items and specification types, ensuring seamless integration of project components. Custom views allow users to display relevant information in task manager and specifications with ease. Moreover, it offers diverse data visualization options such as line charts, pie charts, bar graphs, and other formats to showcase essential metrics, ensuring that teams can interpret data effectively. To enhance project oversight, each work item's state can be configured to require certain mandatory attributes, fostering accountability and precision in project management. This flexibility makes NewSysRS an invaluable tool for any organization looking to streamline its project and requirements management processes.

PEARLS is crafted for remarkable ease of use, strategically built to serve as your comprehensive online requirements management software solution. Featuring a suite of powerful tools, PEARLS simplifies the entire process of managing requirements from their initial conception all the way to final execution. This requirements tracking platform includes a user-friendly management system that streamlines the assignment of roles to various team members, making it more efficient than ever before. The innovative five-step project wizard is designed specifically to save time for business analysts, enhancing productivity. With PEARLS, all essential administrator information can now be consolidated in one convenient location, showcasing the software's organizational prowess. Additionally, PEARLS significantly enhances the effectiveness of defining and managing project use cases, making it an invaluable resource. Furthermore, as the latest editor in requirements management, PEARLS excels at organizing backlog items alongside user stories, thereby optimizing the workflow for business analysts. Ultimately, PEARLS stands out as a comprehensive tool that not only meets but exceeds the expectations of its users.