Basic Concepts

Aligned Elements is a Medical Device ALM that captures and manages the documentation parts in your project that are intended to be under design control.


Aligned Elements is a Project oriented software. The workspace in which a User acts is called a Project. The Project will contain all Design Control Items related to a Medical Device, including the Traceability and the Documents.

Document Objects

The fundamental building blocks of Aligned Elements are the so called Document Objects. A Document Object corresponds to a Design Control item such as requirement, a specification, a use case, a test, a risk etc.

The document object types are defined in xml templates and are therefore highly customizable. These xml files are called Document Object Templates and contain (among other things) the Attributes making up the data set captured by a certain Document Object Type. A Document Object contains a set of attributes e.g. a requirement would have a title, a priority and a description.

Each Document Object Template defines a Document Object Type.

You can modify the existing Document Object Templates or create new templates in order to accommodate to your local quality and development process.


The data set making up a Document Object is under strict version control. All committed changes made to a document object create a new Revision of the object. Consequently, each document object has a Revision Number indicating how many times it has been altered. Old revisions of a document object cannot be altered.


Document Objects can be linked to each other via so called Traces. A trace is a one-way relation between two document objects with a defined direction e.g. a trace from a requirement to a specification indicates that the requirement has been fulfilled by the specification. In Aligned Elements, you can trace any document object to any other document object.

Validation Rules and Inconsistencies

To verify the consistency and completeness of the Document Objects, Aligned Elements uses Validation Rules to validate the existing state of the Document Objects. If the deviates from the Validation Rules' expectations, the deviations are displayed as Inconsistencies.

Pop-up on mouse hover on Document Object IDs

When hovering the mouse over a Document Object ID in any View, a pop-up is displayed containing the information data about the selected Document Object.