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
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
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.
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).
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.
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.
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
- Floating (sometimes also called "concurrent") licenses
- Node Locked (sometimes also called "named" or "personal") licenses
- Review Licenses
All Aligned Elements licenses include support and updates for the full licensing period (1 year) and are paid and renewed yearly.
The minimum term of service for the initial purchase is 12 months.
In due time before the license expiration, you will automatically be sent a license update invoice. You do not have to explicitly contact us for license renewal.
If all the floating licenses are currently in use, the next user logging in will be notified that all floating licenses are currently in use.
Any number of additional licenses can be bought at any time. For administration convenience, we usually suggest that the expiration date for the additional licenses is matched to the expiration date of the initially purchased licenses.
The setup searches for the file WINWORD.EXE file in the path
C:\Program Files\Microsoft Office\root\Office16\ (or similar based on the version of the word)
So you just have to create this path and add a dummy file with the name and extension WINWORD.EXE to this location.
For an optimal display of the Aligned Elements windows client on high screen resolutions, use the "Override High DPI Settings"
How to do it:
1) Find the Aligned Elements shortcut
2) Display Properties (right-click on the short cut) => Compatibility Tab
3) At the bottom of the tab click "Change high DPI settings"
4) At the bottom of the displayed dialog, in the section "High DPI scaling override", tick the check box for "Override high DPI scaling" and select "System" (and not e.g. "System (Enhanced)") in the dropdown.
If this error happened after 2020.03.08, it probably has to do with a prerequisite file that could not be downloaded during the setup.
To proceed, perform the following steps:
Download, unzip and install this file: SSCE x86
Then download, unzip and install this file: SSCE x64
If there are any instructions to restart the computer, please follow them.
Finally, rerun the setup.exe in the Aligned Elements install package to complete the installation.
If you get an error 0x80070BC9 when installing e.g. the prerequisites to Aligned Elements, then this might be caused by installed pending Windows updates requiring a reboot, but the reboot has not yet occurred. Try to reboot your PC and thereafter start the installation of Aligned Elements again.
