Get Started With a Free Trial Today!
Try our world-class eQMS and Design Control Management and see how hundreds of Medical Device companies accelerate their journey with Aligned.
What you get for free:
- 30 days free trial
- Access to the Aligned eQMS
- Access to the Aligned Elements ALM
- Medical Device example projects included
- Free technical support
No Credit Card needed!
If you need a trial extension, just let us know.
Questions before moving ahead?
Absolutely! This is something we definitly recommend and support!
Seeing your own data in action helps you assessing wether the Aligned products are for you.
There are several options available:
Online Trial Version
Sign up for free access to our trial version to get a first overview.
Request a dedicated trial project
If you need a dedicated trial space for several users over longer time, contact our
Plan and Setup a Proof-Of-Concept (POC)
A POC is an excellent way to reduce and manage adoption risks. In a POC, we perform an initial configuration of the system to closer mimic a final outcome. We assist you with an initial training of your trial team. You can then upload your own, real data representing your typical technical file content to properly evaluate the software and validate your assumptions.
In all of these cases, we recommend establish success criteria before starting evaluating. From experience, the "I know it when I see it"-assumption does not always hold.
Very!
From day one, we built our products knowing that each customer will have their own QMS.
Therefore, our systems are built to adapt to each customer's unique situation.
Our idea is that you keep your, terminology, processes, trace structures and document templates and we adapt Aligned to match it.
Result: the fastest possible adoption for your team. They work in a system they recognize and know.
These configuration activities can be done by you, by us or by third-party experts, whatever best suits your situation.
When we engage with customer adaptation work (and the customer knows what he/she wants), we have a configuration available for you within 3-4 days.
The short answer is: no.
No limit on Users
There is no technical cap on the number of users using the system. The usage is limited based on what combination of licenses you have opted for.
No limit on Projects
There is no limit on the number of projects you can manage in the Aligned products.
No limit on Configurations
There is no limit on the number of configurations used on your system. This means you can set up several Aligned configurations in parallell, optimized for dedicated scenarios/end-customers/product lines etc.
At first log in
If you are logging in for the first time and have problems, we have detailed instructions in the user manual.
The most common situations for not being able to log in for the first time are:
- Cannot find the activation email
- The link in the activation email has expired
- Error message "Invalid login attempt" at first log in
Click on the situation that applies to you for explanations and troubleshooting steps.
In General or after resetting your password
If you have log in problems in general or, e.g. after resetting your password, there are instructions and tips available here.
The most common situations for not being able to log in are:
- Error message "Invalid login attempt" at log in
- Locked out after too many tries
- The link in the Reset Password email has expired
- Not using the correct URL/Web address for your Aligned Elements installation
Where applicable, click on the situation that applies to you for explanations and troubleshooting steps.
You can start right away. All data created with the Trial version can be uploaded to a production server once it is in place.
To get the production environment up and running, you can roughly count with two days which would include one full day of training (included in the purchase).
Yes, most definitely. Initially, Aligned Elements integrated quality checks will probably generate a slightly overwhelming number of correction points. However, once you have learned what they mean, you will find them indispensable for providing high-quality, consistent DHF data.
Usability
We know from experience that the maintenance of DHF's is a painstaking undertaking that very few people enthusiastically embrace. Therefore, we try to automate and facilitate the day-to-day DHF Management operations wherever we can, not by cramming in as much new functionality as possible but by selectively offering smart features in the context where it makes the most sense.
Consistency and Control
We want our customers to have full insight into their DHF status at all times and have full confidence in their product documentation. There should be no unpleasant surprises when the auditor arrives or when the 510k is submitted. We are always looking for new ways to quickly and accurately communicate the current consistency state of your DHF's.
Regulatory Add-On:s
A DHF never exists in regulatory isolation and it, therefore, makes sense to include regulatory knowledge and functionality in Aligned Elements.
Integration and Interfaces to external systems
We acknowledge that the benefits derived from Aligned Elements are dependent on its environment and that integration and interfaces with external systems is a natural extension of the product's domain. Aligned Elements' interface- and integration possibilities to external systems will continuously be evaluated and expanded.
Performance and Scalability
We are carefully observing our performance and scalability to make sure that it is not compromised by added functionality. We do extensive testing and keep in close contact with all our users to continuously locate bottlenecks and improve performance and scalability where it is most needed.
