Consistency and Completeness

Real-time consistency checks

Eliminating gaps and inconsistencies in the Design Control Documentation is paramount for all medical device manufacturers. Aligned Elements provides the industry's most extensive range of real-time consistency checks to find:

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

The consistency coverage visually summarizes how much work lies ahead before the documentation is ready to be scrutinized by the auditor.

The consistency coverage view gives direct access to the incomplete items and provides a tool-set for solving inconsistencies immediately. 

Design Reviews

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 save time and reduces error throughout the project.

 

Design History File Index

Design History File Index

A best practice for managing the large number of documents making up the Design History File is to track them in a so-called Design History File Index.

Aligned Elements provides an integrated DHF Index which carefully manages the states of all involved documents and is automatically updated as the documents are modified.

A range of consistency checks can be applied to the DHF Index to visualise the current state of the DHF Index in real-time.

Revision-based change control

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.

Complete Audit trail

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

The audit trail can be searched, sorted, filtered, and exported for further analysis.

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

Branching and Merging of Projects

Branch Aligned Elements projects to enable parallel development throughout the Product Development Life Cycle. Select which Document Object types to include in the Branch.

Merge features back from a branch into the main-line with a few simple clicks.