With the purchase of Aligned Elements, a full day of on-site training for 8-12 people is included. In this training session, we not only work practically with you using Aligned Elements hands-on, but we will also analyse the advantages and disadvantages of your current DHF structure.

Our experience shows that the training session is a great opportunity to harmonize how people work with the DHF content, process, and structures and lay a great foundation to avoid corrective rework later on.

Aligned Elements is explicitly process independent, meaning that your processes can stay just as they are.

Your current Word templates can (most probably) be applied in Aligned Elements' integrated Word reporting mechanism, meaning that the look and feel of your Word templates will stay intact.

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).

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.

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.

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.

Aligned Elements run on the following Microsoft Windows operating systems:

• Windows XP SP 2 or higher
• Windows Vista
• Windows 7
• Windows 8
• Windows 10

Aligned Elements run as a 32bit application on Windows x64 OS.

Aligned Elements requires Microsoft Word to be installed.

The following Microsoft Word versions are supported:

• Microsoft Word 2007
• Microsoft Word 2010
• Microsoft Word 2013
• Microsoft Word 2016

For running Aligned Elements on the 64bit version of Word, please use the designated installer.

For running the Web Server required for the Aligned Elements Web Client, please contact 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..

When you install Aligned Elements, the following prerequisite components are automatically installed (if not already existing on your computer):

• Microsoft SQL Server Native Client
• NET Framework 4.5
• Microsoft Visual Studio Tools for Office 2010
• SQL Server Compact Edition 3.5 SP 2
• Windows Installer 3.1
• MSXML 6.0 Parser and SDK

These are needed for Aligned Elements to be installed and run on your computer

The Aligned Elements Trial runs in the so-called "Offline Mode".

This means that no external server is needed and a small local database is created on your computer.
All projects created with the Trial can later be transferred to a Production Server.

Note that the Trial is set up for an optimized experience with Word 2007/2010/2013.

In Trial mode the following functions are not available:

• Setting Snapshots
• Performing Reviews
• User Management
• Electronic Signatures
• Using Linked Projects