aligned elements 2026: Benefits, Features & Pricing

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Overview
Pricing and Plans
Features
Integrations
User Reviews

Overview

aligned elements

4.1

(14)

Pricing

Starting at €1,300.00 per year

About aligned elements

aligned elements is an on-premise and cloud-based solution that helps medical device businesses leverage requirements management tools to create and trace design controls throughout the application lifecycle. Managers can sign documents electronically and generate reports in Microsoft Word or Excel format.

aligned elements allows organizations to assess cyber assets, vulnerabilities or threats using in-built templates and customize text styles according to requirements. Supervisors can maintain an audit trail to track changes across the entire project lifecycle, create or execute test cases to track defects and store documents in a centralized repository in compliance with various regulatory standards. Additionally, administrators can conduct consistency checks to identify issues such as failed tests, incomplete signatures, and more.

aligned elements facilitates integration with various third-party systems such as Azure DevOps, Redmine and Trac, among others. The product is available on a license basis and support is extended via documentation, FAQs, phone, email and other online measures.

aligned elements Screenshots

aligned elements Pricing and Plans

Starting price: €1,300.00 per year

Free Trial

Free Version

Basic

€1,300.00

per user, per year

No plan information available

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aligned elements Features

Popular features found in Quality Management
Change Management
Complaint Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Management
Electronic Signature
Incident Management
Quality Control
Risk Management
Task Management
Training Management
More features of aligned elements
Access Controls/Permissions
Activity Dashboard
Activity Tracking
Administrator Level Control
Agile Methodologies
Alerts/Escalation
Alerts/Notifications
API
Application Management
Approval Process Control
Archiving & Retention
Assessment Management
Audit Management
Audit Trail
Automatic Test Generation
Baseline Manager
Bug Tracking
Collaboration Tools
Commenting/Notes
Communications Management
Compliance Management
Compliance Tracking
Configurable Workflow
Customizable Fields
Customizable Reports
Customizable Templates
Data Import/Export
Deliverables Management
Document Coding & Control
Document Storage
Drag & Drop
Equipment Management
FDA Compliance
File Management
For Developers
ISO Compliance
ISO Standards Management
Issue Management
Iteration Management
Lifecycle Management
Maintenance Management
@mentions
Monitoring
Multiple Projects
Policy Management
Prioritization
Progress Tracking
Project Planning
Project Tracking
Project Workflow
Real-Time Data
Real-Time Updates
Reporting/Analytics
Reporting & Statistics
Requirements Management
Requirements Review
Risk Assessment
Stakeholder Defined Attributes
Status Tracking
Supplier Quality Control
Task Planning
Task Progress Tracking
Template Management
Test Case Tracking
Testing/QA Management
Test Library Maintenance
Test Run Tracking
Third-Party Integrations
Traceability
Version Control
Workflow Management

aligned elements Integrations

GitHub

Enterprise Architect

Redmine

Jira

GitLab

aligned elements User Reviews

Overall Rating

4.1

Ratings Breakdown

21%

64%

14%

Secondary Ratings

Ease of Use

3.9

Value for money

3.9

Customer support

4.9

Functionality

3.9

Have you used aligned elements and would like to share your experience with others?

Froukje D.

Verified reviewer

Medical Devices

11-50 employees

Used weekly for more than 2 years

Reviewed May 2023

Aligned; a very easy to use and useful tool for requirements management and risk management

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.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

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!

Vendor Response

Thank you for taking the time to provide a very in-depth review!

Replied June 2023

Nicolas R.

Verified reviewer

Medical Devices

51-200 employees

Used weekly for more than 2 years

Reviewed May 2023

Stilla Review

Document generation is sooo cool !

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

Reasons for choosing aligned elements

Pricing

Vendor Response

Thank you for your review Nicolas!

Replied July 2023

Ivo L.

Verified reviewer

Medical Devices

51-200 employees

Used weekly for less than 2 years

Reviewed June 2023

AE covers 80% of the needs

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.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

Reasons for choosing aligned elements

features, price, customer support.

Julie B.

Verified reviewer

Medical Devices

51-200 employees

Used daily for less than 2 years

Reviewed July 2023

Good tool for traceability but good bit more user friendly

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.

Ratings Breakdown

Ease of use

Functionality

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.

Sam A.

Verified reviewer

Biotechnology

51-200 employees

Used daily for less than 12 months

Reviewed June 2023

A great tool that makes managing requirements easier

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.

Ratings Breakdown

Ease of use

Customer support

Functionality

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.

Stefan S.

Verified reviewer

Medical Devices

11-50 employees

Used daily for less than 2 years

Reviewed May 2023

Needs some time but than its fine!

Needs some time to get warm with it, but as soon as you are its working well!

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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

Vendor Response

Thank you for your review! We welcome any feedback you can provide, especially around usability.

Replied June 2023

Reinhard K.

Verified reviewer

Medical Devices

2-10 employees

Used weekly for less than 2 years

Reviewed May 2023

Keeping track of medical device documentation

Excellent support in case of questions and issues. I always got a solution!

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

Vendor Response

Thank you for your review!

Replied June 2023

Filip P.

Verified reviewer

Nanotechnology

1001-5000 employees

Used weekly for more than 2 years

Reviewed June 2023

Nice requirements management system

Using it also for non-medical products. Wherever good requirements management is important, I would recommend Aligned.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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

Vendor Response

Thank you for your review, Filip!

Replied July 2023

Jaimin P.

Verified reviewer

Medical Devices

51-200 employees

Used weekly for more than 2 years

Reviewed July 2023

My experience with AE

AE was good enough to adapt to our development process and risk management process. Content traceability and content control from AE is always appreciated.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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

Stefan H.

Used unspecified for unspecified

Review source

Reviewed October 2015

Great tool for requirements management, risk management and easy traceability handling

This tool is used in our company to support the product development from the design analysis through the system/software requirements to the test cases. Furthermore it provides an integrated risk management module to connect the risk analysis points directly and easily with effected requirements and vice versa. One of the tool benefits is a huge reduce of spent time to create, update and manage several document inputs and the documents itself! Furthermore the tool provides a plenty of possibilities to customize it for the own required purpose.

Ratings Breakdown

Ease of use

Customer support

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