Alternatives to Orcanos ALM and QMS

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.

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.

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.

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!

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.

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

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.

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.

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!

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.

Solutions for insurance tracking and compliance management. Full-service and self-service solutions that automate renewals of insurance certificates or proof of insurance. They also eliminate the need for manual data entry. Software and services for COI tracking that automates the tedious process of collecting certificates of coverage, renewing requests and confirming compliance with third parties. Property managers can easily track the tenant's policies using proof of insurance tracking software. This software helps them to comply with their renter's insurance requirements. Services that simplify the creation, delivery, storage, and management of certificates of insurance. SmartCompliance is the most trusted provider of certificate of insurance, proof of insurance tracking, issuance and compliance management.

Hansoft is an agile project management tool that enterprises can use. Hansoft is fast, efficient, flexible and allows teams to work together more effectively so they can build better products and advance together. Hansoft runs natively on major operating systems such as OS, Windows, Linux and Mac OS. It offers tools for Scrum, tailored agile methods, Kanban and collaborative Gantt scheduling. News feed, chat, document management and external party collaboration. Portfolio analysis, long-term planning, real time reporting, workload analysis, and long-term planning are all possible.

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.

Throughout the Lifeycle, manage, review and release requirements. All changes are subject to strict version control and integrated change impact analysis. A clear visualization of the traceability status and intuitive management of traces will eliminate compliant issues and ensure consistency. You can create, manage, and monitor test cases. Integrate seamlessly with your bug tracking systems. Automate scanning and monitoring your project to detect gaps and trends in your DHF's consistency and completeness. You can digitize your Technical File/ DHF document management with the industry's most flexible Word integration. Medical device companies estimate that documentation activities account for up to 30% of all development efforts.

Kovair ALM offers integrated, collaborative and mouse-configurable capabilities to all phases in Application Lifecycle Management. This includes Project Management, Requirements Management and Development. Kovair ALM is a single source of truth for all users involved in the lifecycle phases. It provides end-to-end traceability, real-time reporting and real-time reporting by using data from all phases. Kovair ALM, which features task-based workflow and notification, allows organizations to establish and enforce central governance across all phases of a project's lifecycle. This allows for the elimination of manual handoffs among teams, cost reduction, process automation across different lifecycle phases, and improved product quality by complying with industry standards. The Kovair ALM Platform has Value Propositions.

DataMetrics is able to provide all product manufacturers with the real-time SPC data and analytics that they require to evaluate current processes and develop a proactive approach to meet or exceed production goals, maintain or improve product quality, reduce scrap and rework costs, comply with industry standards and OEM requirements. The genius interface that connects to your entire manufacturing floor allows for universal data collection from manual, semi-automated and automated data acquisition. This allows you to collect all of your quality data in one central repository or database, and then report on it. Data silos can be eliminated by consolidating data from hundreds gages, sensors and CMM, as well as PLCs. DataMetrics, which is compliant with OPC UA, offers a solution that is backed by strict access control and advanced security.

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.

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.

qmsWrapper is an interconnected Quality Management Software for startups and small businesses. It helps all companies that want to increase productivity with ISO 9001:2015 and MedDev creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820. Best For 1. For companies who need guidance to implement and adopt validated QMS. 2. For companies who want to automate their quality management and go beyond a paper-based system.

Codebeamer is an Application Lifecycle Management platform (ALM) for advanced product and software design. The open platform extends ALM functionality with product line configuration capabilities. It also provides unique configurability to complex processes. Incorporate product teams in automotive engineering and industrial manufacturing. Optimize the delivery and production of complex automotive technology products. Codebeamer provides a complete lifecycle management solution that includes all-in-one requirements and risk management capabilities.

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.

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.

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

Software configuration management solution that is task-based and brings together distributed teams of developers worldwide on a single platform. IBM®, Rational®, Synergy (SCM) is a task-based software configuration management (SCM), solution that brings together global, distributed developers on a single platform. It offers capabilities that enable software and systems developers to collaborate and work faster. IBM Rational Synergy assists software delivery teams to manage global collaboration's complexity and improves overall productivity.

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.

IBM Engineering Lifecycle Management is a comprehensive, end-to-end engineering tool that is at the forefront of its market. It seamlessly guides you from requirements through systems design, workflow and test management. It extends the functionality of ALM to improve complex-systems' development. By adopting a holistic view of the entire product lifecycle and enabling digital data traceability, it is easier to track changes, reduce risk, and minimize costs. Use modelling and reuse to gain insights, and automate reporting for more accurate information. The digital thread's bi-directional data will provide functional, software, mechanical and electrical engineering domains a single source for truth.

Aha! helps companies build lovable software. We provide the world's #1 product development tools — Aha! Roadmaps, Aha! Ideas, Aha! Notebooks, and Aha! Develop — which are used by more than 700,000 builders. Product teams rely on our expertise, guided templates, and training programs via Aha! Academy to be their best. We are proud to be a very different type of high-growth SaaS company. The business is self-funded, profitable, and 100 percent remote. Aha! Roadmaps Set strategy, prioritize features, and build beautiful product roadmaps all in one place — so you can deliver the most product value. Aha! Ideas Crowdsource customer requests in a central ideas portal. Analyze feedback trends and engage with your community — so you can prioritize exactly what to build. Aha! Notebooks Showcase your best thinking with the expert's notebook for product managers. Craft beautiful notes and whiteboards with guided templates. Aha! Develop Empower your engineering team to connect technical work to the product roadmap, optimize workload, and streamline delivery. Aha! Develop is ideal for healthy agile development teams that use scrum, kanban, and SAFe® frameworks.

SoftExpert EQM (enterprise quality management software) is the most comprehensive. It assists companies in achieving and maintaining ISO 9001 certification by automating highly interactive quality processes that are tailored to their specific products, operations, and business practices. As a modular and scalable solution platform, SoftExpert Quality Management Software seamlessly integrates all key quality initiatives, including process mapping, documented information (SOP - standard operating procedures, work instructions and records), non-conformance reports (NCR/NCMR), corrective/preventive actions (CAPA), quality indicators (KPIs). The solution can also manage supplier relations, customer complaints and quality audits, as well as competence and training, quality controls, quality inspection, and statistical process control, increasing QMS flexibility and robustness.

Ennov Doc is part of Ennov's ECM platform for regulated industries, especially the Life Sciences Sector. Our solution is recognized by Gartner as a relevant actor in the Life Sciences sector (mentioned in Gartner's Hype Cycle for Life Sciences Reports as a Regulated SaaS EDMS, as well as for eTMF and QMS) , and suitable for large as well as small organizations. It comprises in the same interface and completely integrated : Document management (EDMS), Business process management (BPMS), Dossier management (composite documents management), Report management, Traceability and security (21 CFR part 11 compliance). With a very intuitive 100% web interface, deployments are easy and user adoption extremely high. Another key point is that document management is "metadata oriented", meaning that documents navigation and search is completely configurable using metadata rather than folder structures. Users can very quickly find documents based on what they are rather than where they are.

Be free from single-owner restrictions Microsoft Office applications can be used to separate software requirements, making it difficult for everyone to stay on the same page. Everyone can collaborate on the most current, up-to date requirements using the Helix RM requirements management software. You will be able to organize and reorganize your hierarchy in real time. It can be difficult to translate business requirements into software specifications. Without a requirement management tool, it can be difficult to translate business requirements into software requirements. Helix RM allows you to break down marketing requirements into product specifications, system specifications, or functional requirements. You can use impact analysis to understand the effect of requirement changes on related requirements (and test case). This is particularly useful for managing your development schedule, and maintaining product quality.

Effectively gather, approve, author, and manage requirements for complex systems throughout entire project lifecycles. All Polarion data is 100% browser-based, enabling synchronicity and ease of access. Real-time communication between engineers, analysts, QA members, and DevOps team members is possible. via threaded discussion, wikis and notifications. Any audit, compliance, and regulatory inspection can be passed with traceability. Every requirement can be easily changed and verified. Work items and documents can be managed using workflows that allow for the enforcement of when and how they move from one state to another based on clearly defined rules. These workflows include full audit trails, electronic signatures, and security. Polarion LiveDocs is an innovative innovation that allows you to collaborate concurrently on specification documents securely and with every paragraph uniquely identifiable and traceable.

Revolutionize your Life Sciences processes. You can dramatically improve the quality, control, and efficiency of your products and processes. Our fully compliant platform is pre-validated according GAMP5. This ensures inspection readiness at all time. You have complete control over all documents and processes. You can also customize workflows and automate when possible. You can enjoy uninterrupted workflows and full traceability with seamlessly connected and integrated modules. Our dedicated team is available to answer any questions you may have. Only the best Scilife experience is possible! Our Scilife platform automates, automates and organizes all processes in your industry space, no matter if you're in Medical Devices or Pharma & Biotech or ATMP. Click below to see which Scilife modules are available for your industry's unique lifecycle stages.

Virje complies to 21 CFR Part 11, 21 CFR Section 820, ISO 13485. Are you overwhelmed by the idea of Part 11 software validation Accessible wherever you are, whenever you work. Automated collaboration and automation can help you reduce paper, lower costs, and increase efficiency. This is the ideal solution for small- to medium-sized businesses. This system was designed specifically for quality control of medical devices. The system is flexible enough that it can adapt to your workflows without having to compromise. Modifiable change order approvals can be configured by employee role or by document type. Notifications to the responsible personnel at each stage of the change process. Ability to identify material dispositions for individual documents. Access to historical and released versions of documents is easy. Quick access to document history. Tracking of locations and distribution of hard copies. Notification of periodic document review.

EQUMAS provides digital solutions that are tailored to the operational needs of our clients. Our multimodal, modular technology is unique and helps manufacturing companies manage their QMS as well as all operational elements. You could use separate systems for quality control, inventory management, equipment management and report compilation. EQUMAS is a powerful, multimodal, integrated software package that can handle your entire workflow. Our system uses the latest AI components to make data driven decisions and find manufacturing deviations faster than humans. Our system integrates all aspects into one platform, allowing real-time communication. This unique feature allows for you to save both time and energy by coordinating multiple software programs to handle your data in one. Manage each employee with their own roles and responsibilities. EQUMAS maintains and tracks specific individual information throughout the platform.

To optimize your shop floor, combine manufacturing, MES and supply chain software. Learn how DELMIAworks, formerly IQMS, can help you improve visibility into every aspect your manufacturing operation and solve the most difficult production problems. Reduce downtime and increase manufacturing efficiency, quality, profit margins, and quality. Real-time data access across the entire supply chain can improve decision making. All ERP, manufacturing, MES and supply chain requirements can be handled by one system. Automating your business can lower your investment and maintenance costs. Our simple-to-use solution will double your plant output, eliminate human error, and improve the efficiency of production planning. To eliminate unplanned downtime, increase throughput and reduce downtime, manage, track and monitor all aspects of the production process. OEE graphs and charts are dynamically updated with performance data and quality data in real time.

objectiF RM management and requirements engineering software provides comprehensive support for requirements elicitation and analysis, modeling, documentation, validation and validation in accordance with IREB and Business Analysis standard. UML and SysML modeling help visualize dependencies, relationships, refinements and processes. Block diagrams can be used to design system architecture. In real-time, requirements specification documents can be created. To verify and validate all requirements, reviews and tests can be performed. Backlogs provide hierarchical structures, while dashboards give current information about the overall status of requirements. Teams can collaborate on objectiFRM on-premise or in the cloud using integrated instant messaging and videocall options.

SILKROAD ALM provides high-reliability software with a lifecycle management system. Its name is "Silk Road", which refers to a historical network of interconnected trade routes that runs across Asia and Europe. It provides interlinking routes to various legacy management systems such as design tools, requirement tools, and test tools. This makes it difficult for many developers to develop reliable software. SILKROAD is a great tool that provides an integrated view of the entire software development lifecycle.

UniPoint's Quality Management Software can be used on-premise to manage quality. Quality Management Software is easy to integrate with other ERP systems. Quality Management Software can be used by manufacturers of any product, in any manufacturing mode. With Quality Management Software, users can manage processes such as document control, equipment management, non-conformances, corrective/prevantative actions, and more.

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.

Quality Collaboration By Design (QCBD), a fully integrated quality management solution, is designed for manufacturing businesses. This Windows-based, affordable application makes it easier to achieve and maintain compliance with quality management standards like ISO 13485 and ISO 9001. CAMA Software's QCBD module offers a variety of modules for supplier management, training management, process deviations management, document control, equipment and more.

Pharmaceutical and Biotech companies face challenges in meeting control documentation requirements in their day-to-day operations. Document management and control are essential components of any quality and compliance solution. Global Regulatory agencies expect all regulated companies to follow industry best practices during the manufacturing process. Phama Soft Sol created Document Management System software to help manage and distribute SOP's, STP's, and other regulated documents. Document management software systems can not only lower compliance costs but also improve product quality and process efficiency. Document Management System (softDMS) allows you to quickly retrieve the information you need, at the exact time you need it. This reduces the risk of miscommunications and errors which in turn minimizes risks, manhours, and other documentation errors.

ZipQuality, a software-enabled medical device service, helps companies bring new products to the market. Our collaboration platform allows agile teams to make rapid design changes while maintaining regulatory compliance. System (processes and tool) pre-configured; no need to change your quality system. The integrated system is able to handle rapid design iterations in product documentation. Your team will be guided by experienced consultants at every stage. Software tools that are fully featured, scalable, and built on the powerful ENOVIA platform. Our integrated system allows for rapid design changes, while keeping data and documentation in sync. All records are maintained in a audit-ready condition. Product requirements, Hardware requirements, Software requirements. We have a deep understanding of complex, software-intensive devices. ZipQuality is a structured documentation system that supports good systems engineering and efficient risk management. It also provides clear traceability.

We offer solutions to companies that have a high standard of quality. Our software solutions are characterized by a modern UX and useful functionality. They also feature high modularity and consistent compliance. Integrated solutions to manage quality and ensure quality. Focused on digitizing controlled documents and QA process. Solutions designed specifically to meet the requirements of the financial sector for written rules of procedure and management of policies. Cloud-based, prevalidated solution for automating your validation processes as well as digitally controlling and managing validation documents. Early setup of a digital quality management system with a solution that is tailored for startups and young businesses. Based on DHC VISION. It is ready to use, with immediate compliance. No license fees. Together, we digitize the quality management and quality control processes and ensure regulatory compliance.

Vault QualityDocs provides automated workflows and audit trails that provide detailed audit trails. This reduces compliance risk and improves quality. It speeds up review and approval and facilitates the sharing SOPs and other GxP documents between employees and partners. Effective SOP management is made easier by automated workflows and visibility to the content status and processes. This reduces compliance risk. An intuitive, user-friendly interface is key to adoption and efficiency. Audit trails with detailed audit trails, content organization, powerful search, and robust search allow for better inspections and audits. You can securely access and use any web browser. If enabled, you can also print, distribute, track, and track the control of PDF copies. Pre-defined metadata and document taxonomy allow for operational harmonization. Organizations can quickly adopt best practices by using pre-defined pick lists for quality, manufacturing and validation documents.

Accompa is 100% cloud-based, allowing remote workers to work in real-time and collaborate to manage requirements efficiently and effectively. Accompa is used by 100s of companies, ranging from Fortune 500s to growing startups, for Product Management, Business Analysis and Engineering. Accompa is a privately owned, financially sound, and profitable company. We are a privately-owned, profitable, and financially sound company that is focused on our customers' needs. As such, we can be relied upon to provide reliable software. Our software is used by hundreds of companies across 6 continents. These companies range from Fortune 500 companies to small businesses. Accompa allows them to create more effective products and services by leveraging Accompa. We understand the challenges faced daily by those who manage requirements gathering, tracking and management.

Almond is a cloud-based professional quality management software designed for healthcare companies. The software allows for computerized management of quality processes that are in compliance with regulatory requirements. The system maintains an audit trail of documents, indexes all documents and provides documented evidence for all QMS processes. All information is centralized in a single place. This allows you to manage your suppliers easily. You can give your suppliers permission to conduct training at their premises using your quality system, if it is required by your system. Receive automatic emails before the expiration of supplier certification. You can be informed at any time about the status of your project using an electronic control dashboard. You can create as many logbooks you need without any budget or storage restrictions. Automatic conversion from ineffective to effective after training completion.

QualityKick provides a QMS solution for the biological sciences. It is divided into different modules, each of which solves a particular part of the quality-management processes: document control and control of training, change control and control of events, CAPA and risk assessment, as well as audits and qualification of suppliers and equipment. It is a web application that can be accessed anywhere and on any mobile device. It works on all devices: computer, tablet, and smartphone. A guided tour is automatically loaded when new users sign in. You can edit documents in MS Word, and then send them to a configurable review process. You can configure different types of events, such as deviations or nonconformities. CAPA plans can be defined, actions recorded, and their effectiveness verified. Solutions for quality management within the pharmaceutical, biotechnology and medicine sectors.

The AssurX platform is a powerful software platform for enterprise quality management (EQMS) and regulatory compliance to reliably communicate and coordinate information, documentation, and activities. AssurX allows regulated businesses to quickly identify and control quality issues and risk exposure to avoid quality or noncompliance problems while improving workflow. AssurX QMS software is uniquely configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. No other system is easier to deploy, configure, and modify. AssurX solutions integrate seamlessly to create a connected quality system. Solutions include audit management, corrective actions, training management, compliant management, document management, change control, risk management, EHS incident management, and more.

ACE Essentials is the pre-validated Electronic Quality Management System Software (EQMS) designed for highly regulated industries. ACE Essentials includes 10 workflows, as well as all the required Standard Operating Procedures (SOPs) and Policies. This ensures that your quality management system is fully compliant from the start. ACE Essentials features include a complete audit trail that tracks every action within the system. This allows you to understand the risks associated assets. Features of ACE Essentials Pre-Configured Workflows Pre-Configured Event Management (Due dates, Scheduling, Reminders) - Pre-Configured Permission Based Security - Pre-Configured Full Documentation - 50+ documents - Multiple Site Capability - No Charge Upgrades for the Product's Life Pre-Configured Tasks Liste - No Validation Period Pre-Configured In System Notifications Pre-Configured Email Notifications

Paradigm 3 is both a web- and desktop-based platform that helps businesses manage compliance in document control, CAPA compliance, Competency Tracking, Training, and Document Control. The software includes tools such as an event manager to handle customer complaints and incident investigations, as well as tasks sent by e-mail and audit preparations. Paradigm 3 is beneficial to the following industries: Manufacturing, Test Labs, Healthcare, and Service Industries.