Corporate Headquarters

Aligned AG
Klingenstrasse 37
CH-8005 Zürich
Schweiz

Telephone: +41 (0)44 312 50 20
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Authorized Persons

Anders Emmerich, CEO

Commercial Register

Registered company name: Aligned AG
Company ID: CH02030298549
Commercial registry office: Zürich
VAT Registration number: CHE‑112.934.507 MWST

Person responsible for content in accordance with 55 Abs. 2 RStV

Karl Johan Larsson, Managing Director

Disclaimer

Accountability for content

The contents of our pages have been created with the utmost care. However, we cannot guarantee the contents' accuracy, completeness or topicality. According to statutory provisions, we are furthermore responsible for our own content on these web pages. In this context, please note that we are accordingly not obliged to monitor merely the transmitted or saved information of third parties, or investigate circumstances pointing to illegal activity. Our obligations to remove or block the use of information under generally applicable laws remain unaffected by this as per §§ 8 to 10 of the Telemedia Act (TMG).

Accountability for links

Responsibility for the content of external links (to web pages of third parties) lies solely with the operators of the linked pages. No violations were evident to us at the time of linking. Should any legal infringement become known to us, we will remove the respective link immediately.

Copyright

The copyrights and all other rights to content, texts or other files on the website belong to Aligned AG or the specifically named rightholders. Unless expressly permitted, every form of utilizing, reproducing or processing works subject to copyright protection on our web pages requires the prior consent of the respective owner of the rights. Individual reproductions of a work are allowed only for private use, so must not serve either directly or indirectly for earnings.

We understand that Aligned Elements customers want the right answers and they want them fast.

In order to provide the best possible support to our clients, we have compiled a comprehensive Support Package that is included in the Aligned Elements licenses model at no extra cost. 

This offer includes:

• Technical Assistance and Support during CET business hours
• Free access to all product updates and service-packs
• FDA QSR 21 CFR Part 11 Assessment for your validation
• Validation Templates for IQ/OQ of Aligned Elements

The Aligned Support Team uses well-defined processes and tools to capture and track all incoming defects and enhancement requests. Our experienced support team has in-depth knowledge of Aligned Elements and stands in close contact with the R&D team to supply the best possible product quality in both the short and long term.

Submit a support request

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.

Thank you for taking interest in Aligned Elements. You will be up and running in a short moment.

• Unzip the downloaded file. (Have you checked the system requirements?)
• Click on the file setup.exe to start the installation.
• Before the Aligned Elements installer starts, a number of prerequisites are installed.
• Click through the Aligned Elements installation Wizard. (Problems during installation? Find solutions here.)
• Open Aligned Elements by clicking on the Aligned Elements application icon under Start->Programs.
• Follow the instructions to open the Aligned Elements sample project.

Contact Aligned Support on This email address is being protected from spambots. You need JavaScript enabled to view it..

There are several ways to insert data into Aligned Elements. The primary way is to use the Document Object forms for manual data entry. DHF data can also be imported from Word, Excel (via csv) and xml (by applying an appropriate XSLT conversion), generated from our regulatory wizards, downloaded and imported from our preconfigured packages on our website, or copied from your existing Aligned Elements projects.

If you have questions, please contact our This email address is being protected from spambots. You need JavaScript enabled to view it..

The primary way of exporting data is to use the Word integration. This mechanism automatically generates Word documents from your DHF data while applying your company Word templates keeping your current look-and-feel intact. Aligned Elements also support a powerful xml/xslt driven export function that outputs all DHF including rich content, traces, etc. You will never be locked-in using Aligned Elements.

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.

Since Aligned Elements is a highly configurable system that is built to adapt to your individual company needs, it does not make much sense for us to validate a pre-configured version that, effectively, never will be used.

We do, however, on request, provide you with pre-filled validation templates for Aligned Elements including a pre-filled FDA QSR 21 CFR Part 11 assessment that can be completed by your company with the missing information.