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Getting Started

What about training?

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.

Do I have to change my processes or my templates?

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.

How fast can I get it up and running?

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).

Is Aligned Elements validated?

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.

Will Aligned Elements really speed up my work?

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.

How do I get the DHF out of Aligned Elements?

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 software requirements

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..

How do I get my current DHF documentation into Aligned Elements?

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..

Installation prerequisites

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

Trial application restrictions

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

Help with installation

Using High DPI settings / high screen resolutions

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.

I get an error when installing the Setup.exe

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.

 

Why does my project load freeze/hang during normal work?

If your network is using a Proxy, make sure that the Aligned License Server (http://license.aligned.ch) is excluded from caching and blockage. Aligned Elements needs both incoming and outgoing access to the License Server.

How do I know that I am using Word x64 (64 bit version)?

If you have installed the x64 Version of Microsoft Word, then you need to use a special installer. Using the regular (Word as 32 bit) installation package on your computer will result in a corresponding warning message.

To find out if you are using the 64 bit of Micorosft Version, open Word's "About" dialog. Where this dialog is located in Word is version dependent.

If the first text line in the dialog contains "64-bit", then you should use the Wordx64 installer of Aligned Elements.

WordVersionScreenshot

 

I get an error 0x80070BC9 when I install Aligned Elements

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.

 

Why doesn't Aligned Elements find my SQL Server on the network?

Type the server and instance name manually in the server combo box (e.g. <MyServerName>\SQLEXPRESS) and press return (Note! Observe that the slash is a backslash, not a front slash!). If you now cannot get connected to your server, the problem might lie in firewall settings on either the client or the server side.

See the AE User Manual for details.

How do I find the version number of my Aligned Elements Client?

Open your Aligned Elements client and select Help -> About.

Aligned Elements crashes when I designate the license file. Why?

Aligned Elements tries to copy the license file into the AE working directory. It might be the case that the current user does not have permission to copy files into the working directory.

Talk to your IT department and see if they can help you copy the license file into the AE working directory.

I installed a different version of Word (or) I installed a number of Office security patches and now I can't even start Aligned Elements anymore.

If the error claims "Unable to cast COM object of type 'Microsoft.Office.Interop.Word.ApplicationClass' to interface type 'Microsoft.Office.Interop.Word._Application'", do the following:

This is an error that can occur if a version of Word (say Word 2010) was installed and later a different (earlier) version of Word is installed (say Word 2007). The technical reason for the error has to do with the Word Primary Interop Assemblies that might have become mixed up.

This error is sometimes solved by uninstalling and reinstalling Word.

Another possible fix is to make the appropriate changes in the registry. In the log error message, there is a CLSID listed (like {00020970-0000-0000-C000-000000000046}). Open the registry editor (Run->Cmd->RegEdt32), copy the CSLID from the log-file (you can get help from Aligned to access the log files and extract the CLID), and perform a search in the HKEY_CLASSES_ROOT for the CLID.

You will find a key matching the CLSID. Expand this key and you should see 3 nodes: ProxyStubCLSID,ProxyStubCLSID32, and the important one - TypeLib. (Essentially what is happening is that when you make the COM call to a specific Office assembly. The assembly opens up the registry and finds this key which gives it the CLSID of the TypeLib it must call in order to initiate a call to the COM.)

The TypeLib key has two sub-entries of which one is a new CLSID. Copy that new CLSID. Now go to HKEY_CLASSES_ROOT->TypeLib and search for an entry matching the new CLSID.

Once you find it, expand it and see if there are multiple versions of the typelib i.e. 8.3, 8.4, 8.5. You want to eliminate the later versions that are pointing to non-existent TypeLib's.

To do this, expand the Version key (ie. 8.3), then expand the "0" key, then the win32 key, and check the value of the default entry. This value should be a file path or a reference to a Word PIA. If the entry is pointing to a Word version that is no longer installed, then simply delete this key, and now when the COM interface attempts to locate the latest TypeLib it will find one that does indeed exist, and will hopefully run error-free.

I get a message that my license file can not be validated and that I shall restore the internet connection. But I DO have connection to the internet. What is wrong?

It seems like Aligned Elements cannot communicate with the license server and/or the internet.

This could happen if the order of your network adapters on your computer is compromised. Check the order of your network adapters and be particularly attentive to network adapters that are invalid or no longer have a corresponding hardware component.

It could also happen if your computer or the network is blocking (e.g. a firewall or a proxy setting) outgoing http calls to http://license.aligned.ch.

More FAQ's

Database Support FAQ

Word Support FAQ

Misc Support FAQ

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