# aligned elements Software Pricing, Alternatives & More 2026 | Capterra > With the help of Capterra, learn about aligned elements Software - reviews, pricing plans, popular comparisons to other Quality Management products and more. Source: https://www.capterra.com/p/145708/aligned-elements/alternatives --- # aligned elements Software Review 2026: Features, Integrations, Pros & Cons Last updated on March 13, 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)[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/) Overall rating Based on 14 user reviews Reviews sentiment Positive \- Neutral \- Negative \- Starting price €1300 Per User, Per Year Free trial available 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... Do you work for aligned elements?[Manage this product listing](https://digitalmarkets.gartner.com/get-listed/claim-bx?url=http://www.aligned.ch&name=aligned elements) ## 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. [4.3 (37)](https://www.capterra.com/p/92271/ALM-2-0/reviews/) Starting Price €1300 Per User, Per Year Starting Price $99 Per Feature, Per Month Free Trial Free Version Pricing Options Free Trial Free Version Ease Of Use 3.9 (14) Ease Of Use 4.3 (37) Value For Money 3.9 (7) Value For Money 4.4 (30) Customer Service 4.9 (13) Customer Service 4.3 (35) ## aligned elements alternatives Highest Rated [4.7 (648)](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 [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 94% of reviewers rated it above 4 stars [4.2 (18)](https://www.capterra.com/p/242193/Tricentis-Tosca/reviews/) Starting price Contact vendor for pricing Pricing Options Free Trial Free Version User Rating 83% of reviewers rated it above 4 stars [4.0 (104)](https://www.capterra.com/p/70008/SpiraTest/reviews/) Starting price $43.66 Per User, Per Month Pricing Options Free Trial Free Version User Rating 85% of reviewers rated it above 4 stars ## Features Features with the highest number of reviews are displayed first. Those that have no reviews appear next, sorted alphabetically. 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 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 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 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 media files, communicate, and work together Document Storage 3.0 (2) 50.00% of 2 reviewers that rated this feature as important or highly important Store and organize documents in a centralized system 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 aligned elements 74 features An @mention is a way to tag or notify a specific person about a message/post Define levels of authorization for access to specific files or systems Dashboard to view the status of ongoing processes, identify current incidents and track past activities Track and document all activities across devices, networks, and other systems Iterative project Management approach that involves technologies such as Kanban, Scrum, XP, APF, XPM and more System alerts about the need to escalate an issue or request Alerts or notifications of various types such as pop-up messages, sounds, banners, or badges Application programming interface that allows for integration with other systems/databases Track, manage and store the applications of potential future members, customers or candidates Manage the process of evaluating documents or requests submitted for approval Moving and separately storing data that is not actively used or continuous storage of data for compliance purposes Creation, administration, and evaluation of assessments or tests Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws A record of all activities within the system, including user access, changes made, etc. Define network parameters and threshold settings to monitor network health and take necessary precautions Monitor and track bugs and issues in the system. Track and monitor efficient handling of all changes/transitions Provides a channel for team members to share media files, communicate, and work together Leave comments and notes on documents for others to view Record and track all relevant internal and external communications Obtain, monitor, and review customer feedback/complaints relating to products and services to improve customer satisfaction Track and manage adherence to policies for any service, product, process, or supplier Track and report regulatory data to either internal management or external stakeholders Configure existing workflows to meet your organization's needs Investigate and take action at root cause or error in processes to prevent recurring issues Customize data fields to support various needs and use cases Alter the layout and content of reports Pre-designed layouts that can be customized to match preferences and requirements Import and export data to and from software applications Process of tracking logged defects (errors) in a product or service to create new versions to fix the error Management and control of the creation, approval, and distribution of documents and processes to ensure they meet industry regulations Store, manage, and track all electronic documents in a centralized location Store and organize documents in a centralized system Assemble applications and processes by dragging over and arranging pre-built components Monitor and maintain equipment used to manufacture and deploy products and services, and to reallocate assets where needed Track and ensure quality of products in accordance with food and drug administration (FDA) act Create, save, and store files For the intention to be used by developers Manage and track all disruptions and incidents Guidelines set by the International Organization for Standardization Track and monitor processes/products to ensure they meet international standards developed by the ISO Identify and respond to unexpected problems or failures (ie. "negative events") Planning out the structure and duration of repetitive intervals of time dedicated to specific tasks during the development cycle Manage the end-to-end lifecycle, from initial setup/development to deployment and maintenance Manage, maintain and track the performance of assets and equipment Observe and track the demand, usage, progress or quality of a system, product, or user Ability to handle several projects simultaneously Create, manage, and track policies and procedures within an organization Arrange tasks based on the level of priority or urgency Reporting on how each user, task or process has advanced since its initiation Organize and schedule projects Monitor the progress of projects from start to finish Create, manage, or update project workflows. Estimate or forecast of a future scenario based on the study of present trends Ensure that quality requirements and standards are met across production processes Receive data and information in real time Receive system updates as soon as any changes are made Collection, analysis, and representation of numerical data and generation of reports to understand various patterns View and track pertinent metrics to find patterns and gain insights from data Enables creation, management, and tracking of product requirements & features during product production/development Initiate collection and analysis of known risks Process of identifying, evaluating, mitigating, addressing and reporting on potential risks or uncertainties Define the exact requirements needed by all stakeholders in the requirements process Track the status over time for a request, process, asset, or transaction Qualify, select, and monitor supply chain partners Create, manage and track all task activities and progression Track the status and progress of tasks Create, save, and re-purpose templates for emails, forms, etc. Checking for errors to prevent quality issues and maintain the integrity of the product/service as per set standards Set up connections to third-party platforms to improve business processes Track and document the history, application, or location of an item or activity Track employee/learner's progression through training programs Track revisions and updates made to files and navigate between different versions 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 Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. 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 Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. 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 Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. 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 Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. 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 Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. 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 Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. 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 [Matrix Requirements](https://www.capterra.com/p/143557/Matrix-Requirements-Medical/) [Greenlight Guru](https://www.capterra.com/p/140578/greenlight-guru/) 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 Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. 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 Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. 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 Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. 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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