--- title: "aligned elements Software Pricing, Alternatives & More 2026 | Capterra" description: "With the help of Capterra, learn about aligned elements Software - reviews, pricing plans, popular comparisons to other Quality Management products and more." source_url: "https://www.capterra.com/p/145708/aligned-elements/" page_type: "product" language: "en" --- # aligned elements Software Review 2026: Features, Integrations, Pros & Cons Last updated on September 16, 2026 Provider data verified by our Software Research team, and reviews moderated by our Reviews Verification team. [Description](#description)[Use cases](#use-cases)[Alternatives](#alternatives)[FAQs](#faqs)[Features](#features)[Pricing](#pricing)[Integrations](#integrations)[Support](#support)[Reviews](#reviews) aligned elements ## What is aligned elements? Aligned eQMS and Aligned Elements Design Control software are built for medical device and IVD companies needing global regulatory compliance without added complexity. The platform supports ISO 13485, FDA QSMR, EU MDR, and IVDR, giving teams full control over quality, design, and regulatory processes across the product lifecycle. Aligned combines a complete electronic QMS with robust Design Control in one integrated system. Design inputs, outputs, verification, validation, risk management, and change control link directly to the QMS for end to end traceability that withstands audits. Built in matrices, impact analysis, and real time status views simplify demonstrating compliance. CAPAs, non-conformities, complaints, and changes connect seamlessly to suppliers, equipment, audits, and documents. Deployable as secure SaaS or on premise, Aligned Elements suits startups, scale ups, and established manufacturers with varying IT and data protection needs. ## What is aligned elements used for? [Requirements Management](https://www.capterra.com/requirements-management-software/)[Application Lifecycle Management](https://www.capterra.com/application-lifecycle-management-software/)[Quality Management](https://www.capterra.com/quality-management-software/) Top alternative Featured Overall rating Based on 14 user reviews Reviews sentiment Positive \- Neutral \- Negative \- Starting price €1300 Per User, Per Year Free trial available Includes Free Version Capterra Shortlist charts the highest-rated and most popular products... Our "Best of" badge program showcases products with the highest ratings... Our "Best of" badge program showcases products with the highest ratings... ## aligned elements Overview Updated September 2026 AI summary Aligned elements supports organizations of all sizes with tools for managing quality, compliance, and requirements across their application lifecycle. Offering features such as audit management, CAPA, document control, and risk assessment, it integrates optional capabilities like API access, customizable reports, and workflow management. Deployment is flexible, with options for cloud, web, or Windows environments. ## Compare with a popular alternative Capterra selects software alternatives based on relevant features, verified user reviews and user interactions. Placement may be influenced by client status. ### aligned elements 4.1 (14) VS. [4.6 (138)](https://www.capterra.com/p/134050/Quality-Management-Software/reviews/) Starting Price €1300 Per User, Per Year Starting Price Contact vendor Free Trial Free Version Pricing Options Free Trial Free Version Ease Of Use 3.9 (14) Ease Of Use 4.5 (37) Value For Money 3.9 (7) Value For Money 4.4 (30) Customer Service 4.9 (13) Customer Service 4.7 (35) ## aligned elements alternatives [4.6 (6,117)](https://www.capterra.com/p/147657/monday-com/reviews/) Starting price $9.00 Per User, Per Month Pricing Options Free Trial Free Version User Rating 94% of reviewers rated it above 4 stars [Orcanos](https://www.capterra.com/p/92271/ALM-2-0/) [4.3 (37)](https://www.capterra.com/p/92271/ALM-2-0/reviews/) Starting price $99.00 Per User, Per Month Pricing Options Free Trial Free Version User Rating 89% of reviewers rated it above 4 stars [Learn More](https://www.capterra.com/p/92271/ALM-2-0/) Highest Rated [Process Street](https://www.capterra.com/p/135004/Process-Street/) [4.7 (652)](https://www.capterra.com/p/135004/Process-Street/reviews/) Starting price Contact vendor for pricing Pricing Options Free Trial Free Version User Rating 96% of reviewers rated it above 4 stars [Learn More](https://www.capterra.com/p/135004/Process-Street/) [Arena QMS](https://www.capterra.com/p/135978/Arena-Quality/) [4.4 (97)](https://www.capterra.com/p/135978/Arena-Quality/reviews/) Starting price Contact vendor for pricing Pricing Options Free Trial Free Version User Rating 95% of reviewers rated it above 4 stars [Learn More](https://www.capterra.com/p/135978/Arena-Quality/) ## FAQs about aligned elements Overview ### Which roles and teams benefit most from aligned elements? aligned elements is most used by R&D, quality, and regulatory teams that need traceability across requirements, risks, tests, and compliance documentation. Project and program managers use it to coordinate delivery and visibility, while IT and engineering roles support structured product development, verification workflows, and audit-ready change control. Answer based on 13 reviews Overview ### What company size and specific industries is aligned elements built for? aligned elements is designed for medical device companies of any size that need application life-cycle management built around regulated product development. It is especially suited to teams working in medical device development, where industry regulations and standards must be supported out of the box. Features and Usability ### What are the key features of aligned elements? aligned elements offers quality management and compliance features such as CAPA, audit trail, compliance tracking, and ISO and FDA compliance. It also includes document management, version control, configurable workflow, task and project tracking, risk management, issue and defect tracking, plus reporting, alerts, and third-party integrations. Integrations ### Which third-party tools and platforms does aligned elements integrate with? aligned elements connects natively to Jira, Azure DevOps Server, Enterprise Architect, Gemini, GitHub, GitLab, Redmine, and Zephyr. These integrations cover issue tracking, DevOps, code hosting, modeling, and test management tools, giving teams a broad set of options for linking work items and development workflows. Answer based on 3 reviews Getting Started and Support ### What training and onboarding options does aligned elements offer? aligned elements provides in person training, live online sessions, documentation, and videos. In person training supports guided instruction, live online sessions allow remote setup help, documentation offers written reference material, and videos provide visual walkthroughs for reviewing features and steps. Getting Started and Support ### What customer support options does aligned elements offer? aligned elements provides Email/Help Desk, FAQ/Forum, and Phone Support. Users can contact the team through written requests, browse self-service guidance, or speak by phone. No reviewer feedback about support quality is available, so response times and helpfulness cannot be assessed from user comments. ## Features AI summary Based on 2,611 Quality Management reviews Capterra data shows that buyers of Quality Management software rank the following features as their top priorities: - **Document Management** (**54%** of reviewers rated this feature as critical) - **Quality Control** (**50%**) - **Compliance Management** (**44%**) aligned elements supports all three features that reviewers identify as most important: **Document Management**, **Quality Control**, and **Compliance Management**. Combined, these capabilities help businesses keep records organized, maintain product and process standards, and stay aligned with regulatory requirements, allowing teams to improve consistency, reduce risk, and manage quality work more efficiently. Document Management 3.3 (4) 100.00% of 4 reviewers that rated this feature as important or highly important Store, manage, and track all electronic documents in a centralized location Quality Control 4.5 (2) 100.00% of 2 reviewers that rated this feature as important or highly important Ensure that quality requirements and standards are met across production processes Change Management 4.5 (4) 100.00% of 4 reviewers that rated this feature as important or highly important Track and monitor efficient handling of all changes/transitions Corrective and Preventive Actions (CAPA) 3.0 (1) 0.00% of 1 reviewers that rated this feature as important or highly important Investigate and take action at root cause or error in processes to prevent recurring issues Traceability 4.7 (6) 116.67% of 6 reviewers that rated this feature as important or highly important Track and document the history, application, or location of an item or activity Collaboration Tools 2.0 (2) 50.00% of 2 reviewers that rated this feature as important or highly important Provides a channel for team members to share AI models, media files, communicate, and work together aligned elements 74 features ### All Features - @mentions: An @mention is a way to tag or notify a specific person about a message/post - Access Controls/Permissions: Define levels of authorization for access to specific files or systems - Activity Dashboard: Dashboard to view the status of ongoing processes, identify current incidents and track past activities - Activity Tracking: Track and document all activities across devices, networks, and other systems - Agile Methodologies: Iterative project Management approach that involves technologies such as Kanban, Scrum, XP, APF, XPM and more - Alerts/Escalation: System alerts about the need to escalate an issue or request - Alerts/Notifications: Alerts or notifications of various types such as pop-up messages, sounds, banners, or badges - API: Application programming interface that allows for integration with other systems/databases - Application Management: Track, manage and store the applications of potential future members, customers or candidates - Approval Process Control: Manage the process of evaluating documents or requests submitted for approval - Archiving & Retention: Moving and separately storing data that is not actively used or continuous storage of data for compliance purposes - Assessment Management: Creation, administration, and evaluation of assessments or tests - Audit Management: Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws - Audit Trail: A record of all activities within the system, including user access, changes made, etc. - Baseline Manager: Define network parameters and threshold settings to monitor network health and take necessary precautions - Bug Tracking: Monitor and track bugs and issues in the system. - Change Management: Track and monitor efficient handling of all changes/transitions - Collaboration Tools: Provides a channel for team members to share AI models, media files, communicate, and work together - Commenting/Notes: Leave comments and notes on documents for others to view - Communications Management: Record and track all relevant internal and external communications - Complaint Management: Obtain, monitor, and review customer feedback/complaints relating to products and services to improve customer satisfaction - Compliance Management: Track and manage adherence to policies for any service, product, process, or supplier - Compliance Tracking: Track and report regulatory data to either internal management or external stakeholders - Configurable Workflow: Configure existing workflows to meet your organization's needs - Corrective and Preventive Actions (CAPA): Investigate and take action at root cause or error in processes to prevent recurring issues - Customizable Fields: Customize data fields to support various needs and use cases - Customizable Reports: Alter the layout and content of reports - Customizable Templates: Pre-designed layouts that can be customized to match preferences and requirements - Data Import/Export: Import and export data to and from software applications - Defect Tracking: Process of tracking logged defects (errors) in a product or service to create new versions to fix the error - Document Coding & Control: Management and control of the creation, approval, and distribution of documents and processes to ensure they meet industry regulations - Document Management: Store, manage, and track all electronic documents in a centralized location - Document Storage: Store and organize documents in a centralized system - Drag & Drop: Assemble applications and processes by dragging over and arranging pre-built components - Equipment Management: Monitor and maintain equipment used to manufacture and deploy products and services, and to reallocate assets where needed - FDA Compliance: Track and ensure quality of products in accordance with food and drug administration (FDA) act - File Management: Create, save, and store files - For Developers: For the intention to be used by developers - Incident Management: Manage and track all disruptions and incidents - ISO Compliance: Guidelines set by the International Organization for Standardization - ISO Standards Management: Track and monitor processes/products to ensure they meet international standards developed by the ISO - Issue Management: Identify and respond to unexpected problems or failures (ie. "negative events") - Iteration Management: Planning out the structure and duration of repetitive intervals of time dedicated to specific tasks during the development cycle - Lifecycle Management: Manage the end-to-end lifecycle, from initial setup/development to deployment and maintenance - Maintenance Management: Manage, maintain and track the performance of assets and equipment - Monitoring: Observe and track the demand, usage, progress or quality of a system, product, or user - Multiple Projects: Ability to handle several projects simultaneously - Policy Management: Create, manage, and track policies and procedures within an organization - Prioritization: Arrange tasks based on the level of priority or urgency - Progress Tracking: Reporting on how each user, task or process has advanced since its initiation - Project Planning: Organize and schedule projects - Project Tracking: Monitor the progress of projects from start to finish - Project Workflow: Create, manage, or update project workflows. - Projections: Estimate or forecast of a future scenario based on the study of present trends - Quality Control: Ensure that quality requirements and standards are met across production processes - Real-Time Data: Receive data and information in real time - Real-Time Updates: Receive system updates as soon as any changes are made - Reporting & Statistics: Collection, analysis, and representation of numerical data and generation of reports to understand various patterns - Reporting/Analytics: View and track pertinent metrics to find patterns and gain insights from data - Requirements Management: Enables creation, management, and tracking of product requirements & features during product production/development - Risk Assessment: Initiate collection and analysis of known risks - Risk Management: Process of identifying, evaluating, mitigating, addressing and reporting on potential risks or uncertainties - Stakeholder Defined Attributes: Define the exact requirements needed by all stakeholders in the requirements process - Status Tracking: Track the status over time for a request, process, asset, or transaction - Supplier Quality Control: Qualify, select, and monitor supply chain partners - Task Management: Create, manage and track all task activities and progression - Task Progress Tracking: Track the status and progress of tasks - Template Management: Create, save, and re-purpose templates for emails, forms, etc. - Testing/QA Management: Checking for errors to prevent quality issues and maintain the integrity of the product/service as per set standards - Third-Party Integrations: Set up connections to third-party platforms to improve business processes - Traceability: Track and document the history, application, or location of an item or activity - Training Management: Track employee/learner's progression through training programs - Version Control: Track revisions and updates made to files and navigate between different versions - Workflow Management: Create, design and manage workflows for repetitive tasks --- Get Advice We can help you find the software with the features you need. Features 3.9 (9) 3.9 Based on 9 reviews ## Pricing Value for money 3.9 (7) Free Trial Free Version Basic €1,300 Per User,Per Year Value for money 3.9 (7) 3.9 Based on 7 reviews ## Integrations [ Jira](https://www.capterra.com/p/19319/JIRA/)[ GitHub](https://www.capterra.com/p/129067/GitHub/)[ GitLab](https://www.capterra.com/p/159806/GitLab/)[ Redmine](https://www.capterra.com/p/212445/Redmine/)[ Azure DevOps Server](https://www.capterra.com/p/177262/Team-Foundation-Server/)[ Enterprise Architect](https://www.capterra.com/p/78757/Enterprise-Architect/)[ Zephyr](https://www.capterra.com/p/173447/Zephyr/)[ Gemini](https://www.capterra.com/p/88290/Gemini/) Connect with a Capterra advisor for a free 15-minute consultation Get a personalized software list aligned to your business needs with guidance from our expert advisors. Our team has helped 1 million+ businesses like yours find options that fit their needs. ## Support, customer service and training options Customer Service 4.9 (13) Support - Email/Help Desk - FAQs/Forum - Knowledge Base - Phone Support - 24/7 (Live rep) - Chat Training - In Person - Live Online - Webinars - Documentation - Videos Deployment - Web - Android - iPhone/iPad Typical users - Freelancers - Small businesses - Mid size businesses - Enterprises Customer Service 4.9 (13) 4.9 Based on 13 reviews ## User reviews Overall rating 4.1 Based on 14 reviews Filter by rating 5(3) 4(9) 3(2) 2(0) 1(0) Mentioned topic Sorted by most recent JB Julie B. Project manager Medical Devices ### "Good tool for traceability but good bit more user friendly" 4.0 Overall Rating 4.0 4.0 Ease of Use 3.0 3.0 Features 4.0 4.0 Customer Service 0.0 0.0 Likelihood to Recommend 6/10 July 7, 2023 It took me a long time to feel comfortable with the software but now that I know how to use it, I like it. However, until the complete development team is not using it in their daily work, we will not use all the functionalities of the software such collaboration or prioritization. Pros I like that the structure of our documentation is directly reflected inside left menu and that this can be customized depending on processes the project needs to follow. This is helping to work according to our processes. Cons Not so user friendly even if this was improved a lot the last 2 years. It is hard to remember how to use the software when it is only for sporadic use, a bit more guidance from the software would be helpful. Review source Vendor Referred - Incentive Offered: This reviewer was invited by the software vendor to submit an honest review and offered a nominal incentive as a thank you. JP Jaimin P. Regulatory Affairs Manager Medical Devices ### "My experience with AE" 3.0 Overall Rating 3.0 3.0 Ease of Use 3.0 3.0 Features 4.0 4.0 Customer Service 4.0 4.0 Likelihood to Recommend 7/10 July 6, 2023 AE was good enough to adapt to our development process and risk management process. Content traceability and content control from AE is always appreciated. Pros Good adaptability with processes, Good content control, and Good traceability of the document objects especially in case of Linked Projects Cons Poor team collaboration as well as limitations in the adaptation of the AE with other tools Review source Vendor Referred - Incentive Offered: This reviewer was invited by the software vendor to submit an honest review and offered a nominal incentive as a thank you. SA Sam A. Quality Engineer Biotechnology ### "A great tool that makes managing requirements easier" 4.0 Overall Rating 4.0 4.0 Ease of Use 5.0 5.0 Features 4.0 4.0 Customer Service 5.0 5.0 Likelihood to Recommend 8/10 June 26, 2023 Aligned Elements is so helpful to us in enabling containment of the design and development process. The team @ Aligned are also incredibly receptive to our requests for customisation, and also always quick to act whenever we have issues or bugs. Pros I really like the organisation which Aligned Elements provides. The ability to link together all items from your business needs and user needs, all the way through the design & development process, including your hazard analysis, verification & validation, will really help when it comes to performing a regulatory submission. With all of the key information being traced, change controlled, and managed in the same space, it is easy to follow the design process from start to finish. Cons I feel there is definitely room to improve in terms of automating some tasks. It would be helpful to have the ability to set up reminder emails with a frequency for tasks which require completion. When adding tables within areas like a Verification test case, having the ability to set the width of columns would be helpful, as sometimes we have found that the visual aspects of a page can get a bit unwieldy, and side scrolling of a page then becomes necessary. Review source Vendor Referred - Incentive Offered: This reviewer was invited by the software vendor to submit an honest review and offered a nominal incentive as a thank you. IL Ivo L. Program Manager Medical Devices ### "AE covers 80% of the needs" 3.0 Overall Rating 3.0 3.0 Ease of Use 4.0 4.0 Features 3.0 3.0 Customer Service 5.0 5.0 Likelihood to Recommend 9/10 June 20, 2023 The product helps a lot to better adhere to processes. Secondly, missing items / traces / reviews are identified with 1 click. It improves efficiency during the life cycle mgmt of a product compared to manual paper work. Even if not used every day, it is intuitive to use. Pros Easy to use. Great user support. Easy configurable for client's needs. Big plus: risk management included compared to other tools. Thus, traceability is easy among the artifacts. Cons Sometimes, 2 AE windows next to each other would be useful to work efficiently -> work around with Word export. Need to log off / on again sometimes due to bugs. Alternatives considered [Polarion ALM](https://www.capterra.com/p/192715/Polarion-ALM/) [Greenlight Guru](https://www.capterra.com/p/140578/greenlight-guru/) [codebeamer](https://www.capterra.com/p/92177/codeBeamer/) Reasons for choosing aligned elements features, price, customer support. Review source Vendor Referred - Incentive Offered: This reviewer was invited by the software vendor to submit an honest review and offered a nominal incentive as a thank you. FP Filip P. PMO Nanotechnology ### "Nice requirements management system" 4.0 Overall Rating 4.0 4.0 Ease of Use 5.0 5.0 Features 4.0 4.0 Customer Service 5.0 5.0 Likelihood to Recommend 8/10 June 19, 2023 Using it also for non-medical products. Wherever good requirements management is important, I would recommend Aligned. Pros \- Requirements management- Risk management- Tracing- Collaboration- Ease of use- Principle / architecture of the system- Tracking changes Cons ReviewsConfiguration management, especially tracing of verification to certain versions of the product Review source Vendor Referred - Incentive Offered: This reviewer was invited by the software vendor to submit an honest review and offered a nominal incentive as a thank you. Response from Vendor July 7, 2023 Thank you for your review, Filip! NR Nicolas R. R&D SQA Director Medical Devices ### "Stilla Review" 4.0 Overall Rating 4.0 4.0 Ease of Use 3.0 3.0 Features 3.0 3.0 Customer Service 5.0 5.0 Likelihood to Recommend 7/10 May 25, 2023 Document generation is sooo cool ! Pros The Support Team : they are doing a GREAT job ! Cons Queries should be more flexible, more powerful. Same for widgets. Widgets should be able to display the results of complex queries.The User Interface is difficult to grasp at the beginning.Need at least 1 to 2 weeks to understand how it is organized. Alternatives considered [Jama Connect](https://www.capterra.com/p/80432/Jama/) Reasons for choosing aligned elements Pricing Review source Vendor Referred - Incentive Offered: This reviewer was invited by the software vendor to submit an honest review and offered a nominal incentive as a thank you. Response from Vendor July 7, 2023 Thank you for your review Nicolas! FD Froukje D. Quality Manager Medical Devices ### "Aligned; a very easy to use and useful tool for requirements management and risk management" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 May 25, 2023 We use Aligned for both risk management (dFMEA 60812 and risk analysis 14971) and requirements management. It is a no nonsense tool, with a good support team, customizable and easy to use. Pros Easy requirement tracing, good trace table creation possibility, quick and personal support from Aligned when you have a problem, possibility to get templates from Aligned and/or create/adapt them yourself (if needed with their help via a video chat). I really like the personal support and the ease of use and tweakability. Cons If you encounter an issue they are very willing to help. They can have a look with you really fast and if the problem requires an Aligned issue, they really want to improve their tool. Alternatives considered [Greenlight Guru](https://www.capterra.com/p/140578/greenlight-guru/) [Matrix Req](https://www.capterra.com/p/10050974/Matrix-Requirements/) Reasons for choosing aligned elements During demonstration is seemed easy to use, it is an inexpensive tool, you can get templates but you also have the option to customize it and support was good. Aligned seemed the best tool to our company and after 5 years still does its job well! Review source Vendor Referred - Incentive Offered: This reviewer was invited by the software vendor to submit an honest review and offered a nominal incentive as a thank you. Response from Vendor June 26, 2023 Thank you for taking the time to provide a very in-depth review! RK Reinhard K. Manager IT and Infrastructure Medical Devices ### "Keeping track of medical device documentation" 4.0 Overall Rating 4.0 4.0 Ease of Use 3.0 3.0 Features 4.0 4.0 Customer Service 5.0 5.0 Likelihood to Recommend 8/10 May 22, 2023 Excellent support in case of questions and issues. I always got a solution! Pros Constency is always assured even in complex projects. Risk management is flexible and reliable. Cons It's a complex project. Setup, configuration and learning to handle it takes a while. Review source Vendor Referred - Incentive Offered: This reviewer was invited by the software vendor to submit an honest review and offered a nominal incentive as a thank you. Response from Vendor June 26, 2023 Thank you for your review! SS Stefan S. Head of Research and Development Medical Devices ### "Needs some time but than its fine!" 4.0 Overall Rating 4.0 4.0 Ease of Use 3.0 3.0 Features 4.0 4.0 Customer Service 5.0 5.0 Likelihood to Recommend 7/10 May 19, 2023 Needs some time to get warm with it, but as soon as you are its working well! Pros Integrates a lot of functions to ensure an accurate development file and to track Requirements Cons Hard to setup and the Usability during daily use is due to the Database like workflow some times difficult Reasons for choosing aligned elements It combines Riskmanagement with Requirements Review source Vendor Referred - Incentive Offered: This reviewer was invited by the software vendor to submit an honest review and offered a nominal incentive as a thank you. Response from Vendor June 26, 2023 Thank you for your review! We welcome any feedback you can provide, especially around usability. BB Beat B. Senior Verification Engineer ### "Great tool with even greater support" 4.0 Overall Rating 4.0 4.0 Ease of Use 4.0 4.0 Features 0.0 0.0 Customer Service 5.0 5.0 Likelihood to Recommend 0/10 November 6, 2015 I have been using Aligned Elements for a few years now in different projects and one of the I like most is the flexibility/customizability of the software, so you can easily adjust it to fit your processes, templates and needs. As with every piece of software you encounter once in a while a problem, but in these cases the guys from Aligned are there within no time to resolve your issue. All in all, aligned has been an excelent experience for me so far. Review source Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. 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