Two words we really like.
You should too, since they mean less work for you!
In this spirit, we created the Aligned Elements Automation Tool to speed up your Medical Device documentation work.
Aligned Elements - configured to match the manufacturer's QMS
But first, let's take a step back.
As you might know, the way a Medical Device Manufacturer's compile their development documentation is largely defined in its Quality Management System (QMS).
The QMS defines the processes, SOPs and templates used to design and document compliant medical devices in the most efficient manner given the manufacturers unique situation.
We go to great lengths to adapt and configure Aligned Elements to each customers QMS.
The result is a unique configuration that helps the manufacturer to write consistent, complete and compliant Design Control Documentation with minimal effort.
The configuration defines things like:
- Consistent naming of all Design Controls
- Customizable Quality Control checks
- Flexible Risk Assessment parametrization
- The Expected Traceability and rules to detect deviations
- Customer specific Report Designs
Each time a new Aligned Elements project is created, the configuration makes sure that the created content is structured and aligned with the manufacturers QMS.
Reusing existing content
However, when documenting a device, it often turns out that much of the created content itself has potential to be reused in other projects.
Moreover, if established content is used uniformly across all device projects, a higher degree of consistency is established.
Such content can include:
- Standard Design Control Items
- Chapter structures
- Trace Tables definitions
- Frequently used Queries
- Dashboard setups
- Chart settings
- Project settings like E-signature preferences and Email SMTP settings
- Users and User Groups
These things have always been reusable in Aligned Elements With the Aligned Elements Automation Tool, it is now possible to transfer these settings to new and existing projects with a single click.
Setting up a new Aligned Elements project containing your company's established best practices is done within seconds!
The Automation Tool is the best way to swiftly leverage existing content in a consistent manner and shorten the project setup time to an absolute minimum.
So how does it work?
The Automation Tool combines a number of action steps in a single xml file and executes these actions against a selected set of projects.
Multiple actions against multiple projects are performed in a single session.
The Automation Tool is installed as a Windows Application for manual use, as well as a Console application which can be used and triggered from other programs.
Note! The Aligned Elements Automation Tool levereges the Aligned Elements REST API. Deploying the Aligned Elements Web Application is thus a prerequisite to use the tool.
The Aligned Elements Automation Tool can be downloaded here.