Medical Device Specific
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.
Design History File Index
A best practice for managing the large amount 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 on the DHF Index to visualise the current state of the DHF Index in real time.
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.
User Management prepared for FDA 21 CFR Part 11 compliance
Aligned Elements implements the technical controls for 21 CFR Part 11. The integrated user management ensures that the right people in your organization have the correct access. All changes to your DHF are tracked and Aligned Elements automatically captures the project audit trail.
In addition, we provide a prepared 21 CFR Part 11 assessment to be completed with your specific local procedural and administrative controls.