aligned elements

RATING:

4.1

(14)

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 ...

aligned elements Pricing

It is also available at $1416.58/yr & $2715.12/yr with additional features.

Starting price: 

€1,300.00 per year

Free trial: 

Available

Free version: 

Available

Aligned Elements hazard analysis

aligned elements Reviews

Overall Rating

4.1

Ratings Breakdown

Secondary Ratings

Ease-of-use

4

Customer Support

5

Value for money

4

Functionality

4

Most Helpful Reviews for aligned elements

1 - 5 of 14 Reviews

Froukje

Medical Devices, 11-50 employees

Used weekly for more than 2 years

Review Source: Capterra

OVERALL RATING:

5

EASE OF USE

5

VALUE FOR MONEY

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

5

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.

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.

Reason 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

Sam

Biotechnology, 51-200 employees

Used daily for less than 12 months

Review Source: Capterra

OVERALL RATING:

4

EASE OF USE

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

4

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.

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.

Ivo

Medical Devices, 51-200 employees

Used weekly for less than 2 years

Review Source: Capterra

OVERALL RATING:

3

EASE OF USE

4

VALUE FOR MONEY

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

3

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.

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.

Reason for choosing aligned elements

features, price, customer support.

Julie

Medical Devices, 51-200 employees

Used daily for less than 2 years

Review Source: Capterra

OVERALL RATING:

4

EASE OF USE

3

FUNCTIONALITY

4

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.

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.

Nicolas

Medical Devices, 51-200 employees

Used weekly for more than 2 years

Review Source: Capterra

OVERALL RATING:

4

EASE OF USE

3

VALUE FOR MONEY

4

CUSTOMER SUPPORT

5

FUNCTIONALITY

3

Reviewed May 2023

Stilla Review

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.

Reason for choosing aligned elements

Pricing

Vendor Response

Thank you for your review Nicolas!

Replied July 2023