Change is not only unavoidable; it is essential for adjustments, optimization, and increased safety.

Support your team constantly navigating evolving regulations, customer feedback, design improvements, and manufacturing adjustment, with a smart change management system.

Track the full context, impact, and rationale behind every change to stay compliant.

Whether a change was driven by an event or an expected process improvement, clearly show the what, when, why, and how of any change.

Changes can be complex. Aligned eQMS assists you in breaking down your Change Requests into clear, actionable implementation tasks.

Assign and approve to automatically distribute individual Change Implementation Tasks to the right people.

As soon as a Task is assigned, the responsible person is notified via automated email alerts and can immediately start processing the task. 

Deadlines are tracked. Statuses are visible to the Change Owner. The Change is completed. The loop is closed.

"If it is not written down, it did not happen."

A regulated environment, like the Med Tech Industry, gives no quarters. Every change must be deliberate, documented, and done right.

The Aligned eQMS is built for medical device manufacturers and purpose built for efficiently achieve compliance with ISO 13485 and FDA 21 CFR Part 820.

With linked impact assessments, electronic approvals, and full audit trails, you will always know who did what, when, and why.

Give your teams a system that transforms change from a bottleneck into a strategic advantage — with structured tasks, real-time accountability, and minimal effort to reach compliance.