Requirements management

Create and manage requirements

User Needs, Design Inputs, and other Requirements are fundamental when compiling your Design History File.

In Aligned Elements, you decide which data you want to capture for Requirement and other types. Editing, versioning, grouping, and tracing are accomplished with ease.

Use a single repository for all your requirements and ensure that there is never any doubt about the current state of your requirement catalogue.

Strict change control and complete audit trail

Any changes made in Aligned Elements takes place under strict version control, without letting the change management get in the way of your work.

A complete, chronologic audit trail of all events is automatically kept during the project life cycle, demonstrating clear accountability and ensuring compliance with regulations such as ISO 13485 and FDA QSR 820.

Cross-Team Collaboration

Requirements management is a highly collaboration-intensive activity requiring close interaction between users.

In Aligned Elements users gather input, discuss, review, approve, sign, and receive notifications about other users’ activity within the software. 

Use customized workflows to implement routing and responsibilities according to your own Quality Management System.

Workflows automate tasks, enforce controls and permissions and notify users of assigned tasks and important events.

Take advantage of existing requirements

Gather and reuse Requirements from multiple sources and leverage your existing data by easily transferring content into Aligned Elements.

Add Requirements in our rich forms, import existing design documents and electronic DHF data from Word, Excel, and xml, generate content from our regulatory wizards, kick-start development with content from our preconfigured extensions, or copy items from your existing Aligned Elements projects.