Consistency and Completeness

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. 

The Aligned Elements regulatory wizard serves two important purposes:

1) As a Q-and-A-based generator of regulatory Items, such as requirements or potential hazards.

2) Guiding the user through regulatory checklists to ensure that the current project state matches desired requirements.

In both cases, Aligned Elements stores the user input and results in its audit trail and makes the result available for Word export.

The state of your current documentation quality at a glance. 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. 

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.

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.

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.

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.

Consistency checks can be applied as process guidance, triggering on-the-fly checks before saving information.

Set up control rules in workflow transitions to automatically verify that the entered information is consistent with the development process before it is committed.

In order to prevent the change management from getting in the way of your work, Aligned Elements provides a number of usability aids.

Recently used change comments and standard company change comments are readily available.

Automatic application of the same change comment to multiple objects in the same change session saves time and effort. Revision comparison simplifies analysis of past changes. Reverting to a previous revision without damaging the audit trail saves manual intervention.

Imagine having a medical device module that is used in multiple products within your company. Aligned Elements makes it possible to create the documentation for the module once and then referer to the applicable content from all Products making use of the module.

Reusing existing Design Control Documentation using linked projects can save a significant amount of time and effort.  

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.