Alternatives to Matrix Requirements

QRA’s tools streamline engineering artifact generation, evaluation, and prediction, refocusing engineers from tedious work to critical path development. Our solutions automate the creation of risk-free project artifacts for high-stakes engineering. Engineers often spend excessive time on the mundane task of refining requirements, with quality metrics varying across industries. QVscribe, QRA's flagship product, streamlines this by automatically consolidating these metrics and applying them to your documentation, identifying risks, errors, and ambiguities. This efficiency allows engineers to focus on more complex challenges. To further simplify requirement authoring, QRA introduced a pioneering five-point scoring system that instills confidence in engineers. A perfect score confirms accurate structure and phrasing, while lower scores prompt corrective guidance. This feature not only refines current requirements but also reduces common errors and enhances authoring skills over time.

SPEC Innovations’ leading model-based systems engineering solution is designed to help your team minimize time-to-market, reduce costs, and mitigate risks, even with the most complex systems. Available as both a cloud-based and on-premise application, it offers an intuitive graphical user interface accessible through any modern web browser. Innoslate's comprehensive lifecycle capabilities include: • Requirements Management • Document Management • System Modeling • Discrete Event Simulation • Monte Carlo Simulation • DoDAF Models and Views • Database Management • Test Management with detailed reports, status updates, results, and more • Real-Time Collaboration And much more.

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.

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.

It can seem like a never-ending series of tradeoffs to bring breakthrough products to market within highly regulated industries. MasterControl's GxP software simplifies workflows, so you don't have to compromise quality for cost or innovation with regulation. Complete and connected meets flexible and fast. MasterControl Quality Excellence transforms quality data and processes to a competitive edge. Modern software is the first step in modernizing your manufacturing operations. MasterControl Manufacturing Excellence, from work orders to production records (EBR/eDHR), to logbooks and work instructions, is the easiest way to digitalize manufacturing.

SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry. SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5. The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more. SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel. Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.

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.

aqua, with its AI-powered technology, is a cutting-edge Test Management System built to streamline and boost QA processes. Perfect for both large and small businesses, especially in highly regulated sectors like Fintech, MedTech, and GovTech, aqua excels in: - Organizing and managing custom testing workflows - Handling various testing scales and complexities, - Managing comprehensive test data sets - Ensuring detailed insights through advanced reporting - Transitioning from manual to automated testing All of this becomes effortless with Aqua. Additionaly, it stands out with "Capture" - simplified 'single-click' bug tracking and reproducing solution. Seamlessly integrating with popular platforms like JIRA, Selenium, and Jenkins, and supported by REST API, aqua enhances QA efficiency, significantly reducing time spent on routine tasks and accelerating software release cycles by 200%. Take away your pain of testing! Try aqua today!

Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals. QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations. Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included. Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com

Intellect's QMS software has been proven to improve quality operations and reduce overall quality cost by up to 40%. Our apps were designed by certified quality professionals and can be easily customized with our no-code platform or drag-and-drop technology. Remote access for your team, mobile apps, dynamic workflows, analytics, reporting, and remote access are all possible with this modern and simple solution. Apps include Document Control and Employee Training, Audit Management CAPA, Nonconformance, as well as other useful features.

Introducing Doc Sheets: Streamline Your Enterprise Lifecycle & Requirements Management Effortlessly Doc Sheets is a powerful, user-friendly software solution that simplifies enterprise lifecycle and requirements management. With an intuitive interface, flexible features, and affordable pricing, it empowers organizations of all sizes to manage documentation and requirements throughout the product development cycle efficiently. Key Features: Intuitive Interface: Easy navigation for technical and non-technical users, minimizing the learning curve. Requirements Tracking: Capture, document, and prioritize requirements with traceability. Project Management: Plan and track tasks, milestones, and deliverables. Test Case Management: Create, organize, and track test cases, ensuring comprehensive coverage. Lifecycle Management: Manage the entire development cycle from planning to release. Customizable for Various Industries: Tailor the software to suit software, embedded systems, medical devices, and more. Collaboration and Version Control: Real-time collaboration and version control to enhance teamwork. Affordable Pricing: Cost-effective pricing for organizations of all sizes. Try Doc Sheets today!

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.

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.

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

Ensure timely and budget-friendly delivery of products with Orcanos, a comprehensive software solution for Application Lifecycle Management (ALM) and Quality Management Systems (QMS). This cost-effective cloud-based platform encompasses various functionalities, including Requirements Management, Test Management, Document Control, Risk Management, and Quality Management, all centralized in one repository. Moreover, Orcanos offers intuitive dashboards and real-time alerts, enabling organizations to monitor their projects effectively and maintain visibility on progress as it occurs. The Orcanos e-DMS functions as a complete document management system tailored for users to create, track, search, archive, and approve all documentation pertinent to each phase of launching a medical device. By facilitating quick access to documents related to planning, design, development, manufacturing, and servicing, the e-DMS enhances the efficiency of quality processes while significantly shortening the time to market. Additionally, this streamlined approach allows businesses to focus on innovation and meeting regulatory requirements without sacrificing productivity.

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.

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.

ZipQuality offers a software-driven service designed to aid medical device manufacturers in launching innovative products. Our collaborative platform adeptly manages swift design modifications for agile teams while upholding regulatory standards. With a pre-configured system that incorporates processes and tools, there’s no necessity to modify your existing quality system. The integrated platform efficiently accommodates rapid design iterations for product documentation. Our team of seasoned consultants supports your team throughout the entire process. Built on the robust ENOVIA platform, our comprehensive, scalable software tools are tailored to meet your needs. This integrated solution allows for quick design adjustments while ensuring that product documentation and data remain synchronized and that all records are maintained in a state ready for audits. We cover essential areas such as product, hardware, and software requirements. Our expertise extends to the complexities of software-heavy medical devices. The ZipQuality framework is founded on a structured documentation approach that enhances systems engineering, promotes effective risk management, and ensures transparent traceability, making it an invaluable asset for any medical device company. Additionally, our commitment to continuous improvement means we regularly update our service offerings to align with industry advancements.

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.

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.

Greenlight Guru is the only product development and quality management platform designed specifically for medical device companies. The Medical Device Success Platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance, and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control, and more. Device makers across the globe are replacing their outdated paper-based and general-purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and achieve True Quality.

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.

Integral QA management and coverage will ensure that you have full visibility and quality coverage. All aspects of manual testing, exploratory testing, and test automation management are included in one central hub of information TEST CASE MANAGEMENT will increase efficiency and reduce the need to do the same job repeatedly. Write your test cases once and then use them again. TEST SETS and RUNS allow you to save time, test faster, and gain deeper testing insights. Cleanly organize your exploratory and scripted tests and execute them Requirement management will help you keep your team's attention. Identify goals and objectives, and track their fulfillment Confidently release products or update products using ISSUE STATUS management You can monitor each phase of the testing process and track real-time progress. SMART AND EASY DATA STRUCTURING makes it easy to find what you need and executes it easily. You can work more efficiently by combining PractiTest elements with your workflow More

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.

Virje meets the standards set forth by 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. If you're feeling daunted by the complexities of Part 11 software validation, rest assured that help is just a click away, no matter where you are or when you need it. By eliminating paperwork, cutting costs, and enhancing productivity through automation and unified collaboration, it becomes an ideal solution for small to medium-sized enterprises. Designed specifically for medical device quality management, this system is constructed to be adaptable to your unique workflows and processes, ensuring you don’t have to make any sacrifices. It features configurable change order approvals that can be tailored by employee role and document type, along with timely notifications sent to accountable team members throughout every phase of the change process. Users can assign material dispositions for specific documents, gain easy access to both released and archived versions, and quickly view the history of document changes. Additionally, it tracks where-used locations and the distribution of hard copies, while also providing reminders for periodic document reviews to ensure compliance and efficiency remain top priorities. This comprehensive approach not only streamlines quality management but also empowers organizations to maintain rigorous standards effortlessly.

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.

Arena PLM assists companies in the high-tech and medical device sectors in swiftly designing, manufacturing, and launching cutting-edge products. By facilitating improved collaboration among all stakeholders involved in new product development (NPD) and new product introduction (NPI), Arena ensures that these processes adhere to essential regulatory standards, including those set by the FDA, ISO, ITAR, EAR, and environmental regulations. This comprehensive approach not only streamlines workflows but also enhances overall product quality and safety.

Transform your Life Sciences operations by significantly enhancing the control, efficiency, and quality of your products and processes. Maintain inspection readiness consistently with our fully compliant platform, which has undergone pre-validation in line with GAMP5 standards. Gain complete oversight of your processes and documentation, allowing for perfectly customized workflows and maximized automation wherever feasible. Experience smooth operations and comprehensive traceability through our seamlessly connected modules. Our committed team is available to address any inquiries you may have at any moment. Only the finest Scilife experience meets our high standards! The Scilife platform not only streamlines but also automates and organizes every aspect of your industry, whether in Medical Devices, Pharma & Biotech, or ATMP. Click below to explore the specific Scilife modules that cater to the distinct lifecycle stages within your industry. Our software is not just equipped with all the essential quality tools you would anticipate; it also comes with numerous additional features that surpass expectations, ensuring your operations thrive. We're excited to partner with you on this transformative journey!

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.

Efficiently collect, create, approve, and oversee requirements for intricate systems throughout the complete project lifecycle. Ensure seamless synchronization and effortless access to all Polarion data through a fully browser-based platform. Foster immediate communication among analysts, engineers, QA personnel, and DevOps teams through threaded discussions, wikis, notifications, alerts, and more. Successfully navigate audits, compliance checks, or regulatory inspections with traceability that is straightforward to implement and assured through automatic change control of each requirement. Oversee work items and documents through workflows that dictate how and when they transition from one state to another based on customizable rules, complete with comprehensive audit trails, electronic signatures, and security measures. A unique feature, Polarion LiveDocs, allows for concurrent and secure collaboration on specification documents, ensuring that every paragraph is distinctly identifiable and traceable, thereby enhancing team productivity and accountability. This approach not only streamlines processes but also elevates the quality and reliability of project outcomes.

Cloud-based Enterprise Quality Management Software tailored for the life sciences sector is essential in navigating today’s intricate operational landscape. With technology at the forefront, it ensures that quality assurance teams are promptly informed of issues as they arise, fostering a culture of proactive management. By gaining a clear view of the quality management system's performance alongside operational conditions, organizations can significantly reduce risks and avoid expensive delays. Montrium has crafted its Enterprise Quality Management System (EQMS) specifically to help life science companies confront their quality management challenges directly, particularly in content management. Our SharePoint QMS modules are designed for flexibility; they can function independently or as part of a cohesive quality management system. These modules are accessible through our Montrium Connect Platform and can be implemented either on-premise or via cloud solutions, making them ideal for pharmaceutical firms, contract manufacturing organizations, and medical device companies. Each component is meticulously built to ensure compliance with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP), thereby supporting organizations in maintaining the highest quality standards. Ultimately, this comprehensive approach not only enhances efficiency but also strengthens the overall integrity of the quality management process.

Honeywell's TrackWise Digital® serves as an innovative cloud-based Quality Management System (QMS) aimed at enhancing the efficiency of quality and compliance processes within organizations. Drawing on nearly thirty years of expertise in the field, it features integrated modules that cater to various elements of quality management, such as document control, training oversight, and corrective and preventive actions (CAPA). The platform utilizes cutting-edge digital technologies, including artificial intelligence and machine learning, to deliver actionable insights in real-time, which fosters a proactive approach to quality management. Its adaptable, modular framework ensures smooth integration with current enterprise systems, allowing for quick deployment and growth. By optimizing quality processes and maintaining adherence to industry regulations, TrackWise Digital® enables organizations to accelerate product launches while effectively reducing risks. This comprehensive system not only enhances operational efficiency but also supports continuous improvement initiatives across the quality management spectrum.

Userdoc is a cutting-edge platform powered by artificial intelligence that aims to simplify the management of software requirements, allowing teams to effectively define features, craft user stories, and integrate with popular project management tools. It plays a crucial role in the scoping of new features and the generation of comprehensive user stories, acceptance criteria, personas, and user journeys, which significantly improves both collaboration and the precision of documentation. By seamlessly connecting with existing project management environments like Jira, Asana, and GitHub, Userdoc ensures that requirements remain organized and current throughout the entire development process. Additionally, the platform provides various export options, including MS Word, MS Excel, and CSV formats, which makes sharing information and maintaining compliance straightforward. Utilizing AI technology, Userdoc not only expedites the process of creating software requirements but also reduces the hours spent on manual documentation, enabling teams to dedicate more time to the development of high-quality software. Overall, Userdoc empowers teams to enhance their workflow and achieve greater efficiency in their projects.

The EzyPro Adaptive Management system (QHSE) serves as a robust platform for merging compliance, performance, and ongoing enhancement efforts. It functions as a comprehensive solution for compliance, maintenance, and operational oversight, allowing for improved efficiency, information sharing, and collaboration among users. Featuring a modular design, it provides adaptable subscription options tailored to specific requirements. EzyPro Healthcare stands out as a Hospital Quality Management system that incorporates action tracking and dashboards to fulfill standards set by NABH and JCI, acting as a central hub for continuous improvement within healthcare facilities. Additionally, there is an option for remote consultancy services to assist with the implementation process. For the first time, a thorough maintenance management solution is paired with the QHSE Management system, aimed at prolonging the lifespan of equipment while enhancing time efficiency and equipment availability, ultimately leading to reduced expenses and increased profitability. Furthermore, the system includes QR code-assisted asset retrieval, which simplifies the management of work orders related to repairs, maintenance, or asset transfers, making it an invaluable tool for organizations. This innovative approach not only streamlines operations but also fosters a culture of accountability and excellence within the organization.

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.

ZenQMS improves the quality compliance profiles life sciences companies through a cloud-based platform. It is purpose-built to facilitate document collaboration, control, training, issues management, audits, and change management. ZenQMS is a team of technology and quality leaders who share the common goal of making quality management a business imperative.

Enhance your software development visibility by utilizing a flexible and secure management platform that accommodates both traditional and bi-modal development approaches. This solution enables you to improve delivery speeds and minimize expenses while adhering to necessary compliance processes. It fosters effective collaboration among cross-functional teams, allowing them to exchange expertise, best practices, and code seamlessly. Ensure the quality of your software through comprehensive traceability across various tools, teams, and workflows. You can oversee both distributed Git and centralized Subversion (SVN) version control systems from a single platform. With real-time data, enterprise-wide rollups grant managers unmatched capabilities in monitoring, reporting, and analysis. By uniting global teams, you can safely assign role-based access and enhance cohesion across different tools through TeamForge®'s robust integration and collaboration features. This comprehensive approach not only streamlines development but also empowers teams to innovate and respond to market demands more effectively.

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.

Opvia empowers R&D, Manufacturing and Quality Management teams to build custom Process Operating Systems that streamline their workflows, giving them a competitive advantage. We work with startups and enterprises in a variety of industries including biotech, pharmaceuticals, food and beverage, engineering, and medical devices to digitize their processes. Our powerful tools and expert assistance give companies the freedom they need to create and deliver in a way that has never been possible before.

QEdge QMS is Enterprise Quality Management Software (EQMS). It optimizes quality and ensures regulatory compliance. Enterprise Quality Management Software (EQMS), reduces the risk for quality process failures, lowers overall costs, and makes organizational processes more compliant. QEdge is an EQMS that allows companies to manage their Quality Management System in a disciplinary regulatory environment. It brings together all quality processes, such as Change Control and Deviation, Investigation and Market Complaints. OOS, OOT and Risk Assessment. Document Control activities, Training Records, and Document Control activities. QEdge, an intuitive and configurable software platform, allows for cross-functional communication and collaboration. It can interface with legacy systems and facilitates error-free, cross functional communication.

Quality Collaboration By Design (QCBD) offers a comprehensive quality management software solution tailored for the manufacturing sector. This cost-effective, Windows-compatible application streamlines the process of obtaining and sustaining compliance with various quality management standards, including ISO 13485, ISO 9001, TS 16949, AS9100, and SQF 2000 / ISO 22000. Developed by CAMA Software, QCBD encompasses a wide range of modules that facilitate training management, supplier oversight, process deviation tracking, document control, equipment management, and additional functionalities. With its user-friendly interface, QCBD not only enhances operational efficiency but also ensures that businesses can easily adapt to evolving quality requirements.

We provide tailored solutions for businesses that prioritize high-quality standards. Our innovative software is designed with a contemporary user experience, practical features, extensive modularity, and unwavering adherence to regulations. We deliver integrated solutions for both quality management and assurance, placing an emphasis on the digitization of regulated documents and quality assurance workflows. Our offerings cater specifically to the financial sector's requirements regarding procedural documentation, policy management, and information security oversight. With our cloud-based, pre-validated system, organizations can streamline their validation workflows and efficiently manage validation documents in a digital format. We also facilitate the early establishment of a digital Quality Management System (QMS), especially crafted for startups and emerging enterprises. Utilizing DHC VISION, our solution is ready for immediate deployment, ensuring compliance without incurring any licensing fees. Together, we transform quality management and assurance processes, paving the way for robust regulatory compliance and enhanced operational efficiency. Our commitment is to empower businesses by making quality processes not only accessible but also seamless.

HQMS applications, available on-premise or hosted, including Document Control, Audits, Corrective Action, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management and the HQMS Supplier Portal. Robust technical capability, including, configuration, personalization, and customization, with flexible and customizable security options, any HTML5 browser, Single Sign-On, and more. Integration with ERP and other apps. HQMS across several markets, including manufacturing (Aerospace and Defense, Automotive, Consumer Products, Medical Device, Food, Energy, and more), healthcare, retail, non-profits, and government.. Highly secure Document Control, Audits, Corrective Action, Calibration, Training, and the HQMS Supplier Portal with personalization, configuration, customization, and integration.

A cloud-based platform designed for product teams of all sizes, facilitating collaboration on requirements, issues, and change management. Managing a product presents distinctive challenges as it balances various aspects such as product vision, design, development, and sales. This role necessitates a shared language to effectively communicate requirements and priorities among executive leadership, sales, and engineering teams. Reqchoir serves as a comprehensive dashboard that empowers cross-functional teams to achieve this objective. As a web and cloud-based solution, Reqchoir allows users to capture and oversee requirements, issues, and associated team workflows effortlessly. Accessible from laptops, tablets, or mobile devices, teams can enhance their processes and product quality through effective collaborative product management, ensuring that all members are aligned and informed throughout the project lifecycle. This promotes a more streamlined and productive approach to tackling the complexities of product development.

Your customers and shareholders will be delighted by your profitable products. Buyers have changed. Supply chains are in chaos. The definition of a product is being redefined. However, product development technologies have not kept pace. We need a new approach. One that is focused on patient and customer outcomes. This helps product companies make the right decisions. This engages markets with engaging products and experiences. This is called product value management (PVM). Collaboration with all stakeholders, including suppliers and customers, is essential to develop and launch innovative products. Design for product quality and manage part quality. Take action to resolve quality issues. To engage customers with enhanced omnichannel product experiences, leverage a trusted source of product information.