Frequently Asked Questions

What is Aligned Elements?

Aligned Elements is as system built to compile and manage the project and product documentation of your Medical Devices (called Design History File or DHF) by efficiently controlling a large number of individual but related Design Control items.

 

What is the latest product version?

The latest version of Aligned Elements is V1.7.0.11.

 

What are your prices?

Please contact us on sales@aligned.ch for a quotation.

 

What is included in the price?

The price includes:
- The server installation (but not the server software itself, see below)
- An unlimited number of client installations depending on license type purchased
- The 8 hours Aligned Elements training for maximum 10 people
- 8 hours of customization and consultation

Furthermore, an extensive Support and Maintenance package is included. For detailed information on the Support Package. Read more here [click].

Note that neither server Windows software, Word nor the SQL Server is included in the price. These have to be purchased separately from Microsoft.

 

Is Aligned Elements Validated?

Since Aligned Elements is a configurable product and each customer configuration is slightly different, we cannot provide a comprehensible validation.

However, we do support your validation effort with:

- Prefilled Validation Templates

- Prefilled FDA 21 CRF Part 11 assessment

- Access to our Development Documentation

- Help with carrying out the validation itself

 

Can I operate Aligned Elements from a remote location?

Yes, if you set up a VPN connection (Virtual Private Network) to your server location you can access your AE projects remotely. The performance is dependent on the connection bandwidth. Aligned Elements also operates on Citrix and with replicating SQL Servers.

 

Can I operate Aligned Elements without Internet Connection?

Yes, it is possible to take a project Offline, which creates a local copy of the project on your disk. This enables you to work on your documentation when you have no internet connection. Changes made Offline can later be synchronized back online.

 

Can I import my current DHF documentation into Aligned Elements?

If your DHF documentation is available in Word documents, Excel or any output that can be transformed to xml, then the Aligned Elements Word Customization can be used for import.

For data migration from other systems, see below.

Can I migrate data from Telelogic DOORS or IBM Requisite Pro?

Aligned Elements has import interfaces for XML files. Data from any system that can export into XML format can be imported into Aligned Elements. Data can also be directly imported from Word Documents.

 

How do I get a demo or trial version of the software?

Yes, you can [click here].

 

How long is the free trial period?

The free trail period is usually 30 days. If this time frame should be too short for your evaluation an extension of the trail period can be requested.

 

Whom do I contact for technical support?

Please constant us by sending a mail to support@aligned.ch. For more information, read here [click].

 

Which database does Aligned Elements use?

Aligned Elements uses SQL Server 2005 or SQL Server 2008 for online use and SQL Server Compact Edition 3.5 for Offline use. At the server installation, we install SQL Server 2005 Express or SQL Express 2008.