When submitting your Technical File, the last thing you want is doubt. Gaps, inconsistencies, and missing things in your Design Control Documentation can lead to delayed market access and lost revenues.

Uncover and eliminate inconsistencies such as:

• Missing, suspect, and illegal traces
• Insufficiently mitigated risks
• Unexecuted and failed tests
• Incomplete and inconsistent Documents

Our visual consistency coverage shows you exactly where you stand and how far you have to go. No more guesswork. 20+ inconsistency rules available to provide complete transparency.

With powerful real-time consistency checks, you’ll instantly uncover what’s incomplete, risky, or out of sync before things get critical.

And when issues arise? You are only a click away from resolving them.

With our context-driven solution suggestions, Aligned Elements presents you with the available options. Select and work through the best option given the current circumstances, and the gap is closed. 

Reviewing is a required task in medical device development documentation, used both to enhance quality and ensure accountability. 

Reviewing is also a notoriously time-consuming activity. By tightly integrating a collaborative design review process into Aligned Elements, much time and effort is saved. The review status and post-review modifications of each individual Design Control Item are carefully tracked.  

Instant revision comparison, highlighting of unreviewed changes, and automatic review document generation saves time and reduces error throughout the project.

To achieve clarity at every step., knowing exactly who changed what, when, and why is a prerequisite. With change control occurring automatically, teams work with confidence. Communication improves, and regulatory risk is minimized without disturbing your flow.

All changes made to all Design Control Items require a change comment from the user, explaining the reason for the change. In this fashion, each change is tracked including why, when, what, and by whom.

The modified item automatically gets a new revision number and can at later stages be compared to previous revisions.

Trust is built up on accountability. With an audit trail, every change in your design process is documented and explained, turning compliance from a burden into a built-in strength.

By capturing the full context of each modification, you ensure accountability is always clear and effortless to demonstrate.

All changes made in the project, including modification, trace changes, and other actions, are recorded in a chronological audit trail.

Each Design Control Item has its own revision history readily available in the Document Object form for analysis and comparison.