# 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="" %} --- # Agent Instructions: Querying This Documentation If you need additional information that is not directly available in this page, you can query the documentation dynamically by asking a question. Perform an HTTP GET request on the current page URL with the `ask` query parameter: ``` GET https://docs.aligned.ch/aligned-elements-web-client-user-manual/3.2.287.25450/basic-concepts.md?ask= ``` The question should be specific, self-contained, and written in natural language. The response will contain a direct answer to the question and relevant excerpts and sources from the documentation. Use this mechanism when the answer is not explicitly present in the current page, you need clarification or additional context, or you want to retrieve related documentation sections.