> For the complete documentation index, see [llms.txt](https://docs.aligned.ch/aligned-elements-web-client-user-manual/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://docs.aligned.ch/aligned-elements-web-client-user-manual/3.2.301.26526/basic-concepts.md). # 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. ## Projects 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 a 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, which 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 your local quality and development process. ## Revisions 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. ## Traces Document Objects can be linked to each other via "**Traces"**. A trace is a one-way relationship 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. {% embed url="" %}