Aligned Elements Product News

March 22 2019

Reuse. Automation.
Two words we really like.
You should too, since they mean less work for you!

Robot

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

Automated Reuse

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.

Automation Tool

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.

February 08 2019

What's New

This service pack contains an assortment of small to medium improvements. As always, it is based on a significant amount of input from the Aligned Elements User Community. The strongest focus is on improvements in the user management, web usability and Word reporting.

 

Improved User Handling

Collaboration with development partners in Aligned Elements is definitely something that will speed up your documentation work. But sometimes, some functions and data should stay off-limits for your partners.
With improved access management, Aligned Elements restricts access to functions and data and ensures that information is shared on a need-to-know basis. Optional log-in with Microsoft credentials is also possible, as well as optional display of full name and/or email of users wherever user actions are displayed.

 

User Groups

 

Inline Editing in Tables

The Aligned Elements Web client now supports inline editing in Design Control Items tables. This greatly improves usability as the Items don't have to be accessed individually for editing. A set of Items is opened for editing in table mode with a single click. Select the attributes to be displayed in the table, edit as you like and save all items with a single click.

 

InlineEditing

 

Word Improvements

Aligned Elements now optionally keeps track of Design Control Items inserted as Queries, Risk Tables and Trace Tables and will highlight any outdated documents where the items have changed after they were placed in the document. More flexibility in handling Word Template variants and enhanced coloring of Risk Assessments are welcome contributions from our users.

 

version office 14

 

What's Changed

  • Automatically add new Items to active Tags
  • Test Runs - Automatic removal of old attachments and issues at re-execution
  • Test Runs - Assign failed tests to new Test Run
  • Project Search Bar in Open Project Dialog
  • Generate, copy or execute multiple items in a single action
  • Signature stamp improvements now includes time and time zone information
  • Set Traces to existing items in Table Attributes
  • Import / Export of Project Settings
  • Synchronized import without synchmap files

Upgrade now

With important fixes and a handful improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 6 here.

July 10 2018

What's New

Aligned Elements V2.4 SP 5 (2.4.213.14327) is a hotfix for solving an upgrade problem for projects from V2.4 SP 2 and earlier to the newest version of Aligned Elements.

Upgrade now

This is the recommended version.

Find the installer to Aligned Elements V2.4 SP 5 here.

July 03 2018

What's New

With a complete overhaul of the Aligned Elements Web Client frontend, we are pleased to give you a much better user experience. In this release we also introduce the Aligned Element dashboards, improvements to the Review Experience as well as several changes requested by our customers (to whom we always listen!)

 

Dashboards

Have you ever thought that although there is an immense amount of valuable information in Aligned Elements, getting the overview of the current state of affairs is not particularly straight forward. Enter Dashboards, you can now configure your own cockpit from a large number of Widget types. Web client information at your fingertips!

Dashboard

 

Web Client Frontend UX Enhancements

With a proper Sidebar navigation as well as side-by-side operations of Project/Trace Explorer and the Items, the need for jumping back and forth is significantly reduced. Event based updates removes the needs of manual refreshing. A useful Test Run Burndown chart is now tracks your progress.

Frontend

 

Enhance Design Review UX

The Design Reviews now display the Design Control Items just like they appear in your documents. You can create and assign issues directly to the Design Control Items without having to leave the context. We have also added an option for the Reviewer explicitly state completion of all assigned tasks with a single button click.

Review

 

What's Changed

  • New Inconsistency rules for Missing Test Executions in Test Runs and Unique attribute values
  • Improvements in management of External Issue Management systems
  • Clearing File attribute values
  • Warn on commit on selected inconsistencies
  • Improved performance for Cloud Projects

Upgrade now

With important fixes and a handful improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 4 here.

November 11 2017

The IVDR (Regulation EU 2017/746), published in the EU Official Journal on May 5th, will have a significant impact on the manufacturers making IVDR products. 

IVDR EU Regulation 2017 746

The BSI Group calls the new risk classification in the IVDR  a “quantum leap” for products that could have been self-certified under the old directive to products soon needing notified body certification under the new regulation. Access to notified bodies has been  identified as a major bottleneck in the years to come.

IVD companies targeting the european market should therefore move swiftly and resolutly if they desire to stay in business. Compiling the Technical File could be one such task.

The EU IVDR Annex I General Safety and Performance Requirements section corresponds to the Essential Requirements section in MDD Annex I.

If you want to check how your current Technical Files complies with these Requirements, you can download our check list here:

IVDR (EU 2017/746) Annex I General Safety and Performance Requirements

Just like the MDR Annex I General Requirements, the IVDR Annex I counterparts are also available to Aligned Elements users as a free extension.

IVDR Annex I Requirements can be imported as Design Control into any of your Aligned Elements projects and included in the traceability. The extension corresponds to the requirements in the 31 page check list and are made readily available in your traceability in a matter of seconds!

Kickstarting your Technical File compilation with the IVDR Annex I General Requirements extension, available to Aligned Elements user in order to helps them accelerate their medical device Design Control documentation effort. Browse through the available extensions and discover how they could accelerate your project.

The extension is available here: IVDR (EU 2017/746) Annex I Extension

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