Aligned Elements Product News

Juni 27 2019

What's New

Aligned Elements V2.5 is here and brings a host of new enhancement and fixes. 

 

Branching and Merging Projects

Branch Aligned Elements projects to enable parallel development throughout the Product Development Life Cycle. For example, when V1.0 of your device has been released, branching the project ensures that your next release V2.0 can be developed in parallel with any fixes required to V1.0. Merge features back from a branch into the mainline with a few simple clicks.

 

Branch

 

Native Word Integration from Aligned Elements Web Client

The Aligned Elements Web Client now provides a native Word Add-In which makes it possible to an incredibly flexible report creator, freely mixing regular Word Content with Aligned Elements content. All Word Integration features available in the Aligned Elements Windows client are now available in our Web Application as well. Select a Document in Aligned Elements and Word will automatically start with the Word Add-In displayed on the right side of the Word application.

 

WordAddIn

 

Risk Assessment Improvements

Upon customer request, we have expanded the range of options available for configuring Risk Assessments, including Probability and Severity text dropdowns, unlimited number of risk zones with customizable coloring and fully customizable risk result presentation.

 

risks

 

What's Changed

  • Automatically pre-populate project with content at project creation
  • Dynamic List Attribute - expand selectable items range from GUI
  • Group Test Runs
  • Group User Favourites
  • Filter Office Explorer on Tags
  • Workflow action: Generate Object
  • Enhanced Security
  • Incoming suspect Trace validation rule
  • Validation on Incoming Trace rule
  • Illegal Trace From validation rule

Upgrade now

With important fixes and a handful improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 here.

März 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.

Februar 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.

Juli 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.

Juli 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

November 06 2017

What's New

Continued integration with external systems has been the theme of this release. We are glad to have incorporated GitHub tickets in our ecosystem. Operating with Linked Projects has now also become easier.

Hello, GitHub!

We are finally integrating towards the tickets of the most popular source code control system on the planet! The GitHub integration allows you to create, modify and trace towards GitHub Tickets e.g. when you are performing your Tests.

GithubBig

 

Web Client Usability

Improved linked project support as well as the display of Help Texts have been implemented in this release.

HelpText

 

Starting external processes

Via Workflows, it is now possible to start external processes, triggered by events in Aligend Elements. These external processes can be fed with Aligned Elements content for further processing.

adam

 

What's Changed

  • A new Inconsistency rule detecting obsolete traces
  • Default texts in Table attributes
  • Renaming of Files in Web Client
  • Creating Projects with templates in Azure File Storage
  • Optional automatic updates of linked traces

Upgrade now

With important fixes and a handfull improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 3 here.

Juli 17 2017

What's New

In this release, we have continued to expand existing features in alignment with our customers feedback. Charts are now persistent, the Web client is getting really smooth and the powerful Test Run gets even more powerful.

Charts

Although charts have been a feature of Aligned Elements quite a while, you can now save them and integrate them in your Word reports.The Chart Designer lets you design and organize your charts and present the project's Design Control data in the most capturing way.

workWithCharts

Web Client Usability

We have included popovers of Document Objects when hovering on Document Object IDs in the Web Client. This gives a quick preview of the item's content without having to leave your context.

popup

Test Run Improvements

Test Runs have been enthusiastically received by the Aligned Elements User community. In this release, we have added new requested features, improved performance and fixed a number of bugs.

TestRunPic

What's Changed

  • Two new Inconsistency rules
  • Signalize suspect traces across project boundaries
  • Improved import mapping capabilities
  • Improved reliability and performance for Word Reports
  • Additional DB security options- Chapter content optionionally displayed as lists

Upgrade now

With more than 100 enhancements, fixes and improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 2 here.

Juni 23 2017

Performing Medical Device Cybersecurity Risk Assessments is something we Medical Device Manufacturers must get used to. And the sooner the better, During 2016 and 2017 a mounting number of health associated cybersecurity incidents have been reported. Cybersecurity breaches may well become THE main safety concern in our industry within the next few years. Increased regulation on this matter is to be expected.

Hacking

FDA has already published guidelines on its view on how medical device manufacturers ought to address cybersecurity in Medical Devices. The guidance outlines the documentation FDA expect to see in the premarket submissions as well as what is expected to be conducted for SOUPs and during postmarket activities.

At the core of this documentation lies the Cybersecurity Risk assessment. As already discussed, this type of risk assessment is slightly different to the typical Design Risk Assessment conducted during development.

To address this task, which many manufacturers will have to perform, we have developed a risk assessment template set specifically for documenting Cybersecurity risks and mitigations.

This template package is free to download and use for all Aligned Elements customers.

Are you interested in how the Cybersecurity Risk Assessment can be conducted and integrated with the rest of your Design Controls?

Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein! for a free demonstration!

The Aligned Elements Cybersecurity Risk Assessment package contains:

  • Risk assessment templates based on AAMI TIR 32, modelling Assets, Threats, Vulnerabilities and Risk Controls as Measures
  • More than 30 Best Practice Cybersecurity Risk Mitigations ready to use

If you are looking for a Cybersecurity Risk Assessment Word Template, you can download an example here:

Cyber Security Risk Assessment Word Template

 

Mai 07 2017

On May 5th, the final texts of the MDR (Regulation EU 2017/745) and the IVDR were published in the EU Official Journal

It's quite a chunk of text and if you have not yet started to update your Quality Management System, SOP:s and Technical Files, you should (seriously!) take some to to plan these actions accordingly.

 MDRJournal

The EU MDR 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 checklist here:

MDR (EU 2017/745) Annex I General Safety and Performance Requirements Checklist

The MDR Annex I General Requirements are also available to Aligned Elements users as a free extension. This means that the MDR 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 37 page check list and are made readily available in your traceability in a matter of seconds!

The MDR Annex I General Requirements extension is yet another of the many available free extensions available to Aligned Elements user which 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: MDR (EU 2017/745) Annex I Extension

April 11 2017

With the Aligned Elements V2.4 Service Pack 1 (2.4.132.12658) we have fixed a small number of bugs.

This service pack mainly addresses known problems with Word 2010 and Word 2007 from Aligned Elements V2.4.

It also provide fixes to the integration mechanims with Countersoft Gemini and the usability of Test Runs.

If your team is using Word 2010 or Word 2007, you are recommended to upgrade to this service pack.

Oktober 29 2016

A few years ago we could read articles claiming "Exoskeletons will one day replace wheelchairs". That the FDA regulates these kind of devices is a clear sign that they are about to enter the mass market.

Miniaturization of electronics, a steep drop in manufacturing costs of mechatronic parts, increased computational power, more powerful batteries. A number of recent technical developments converge into the realization of exoskeletons growing nearer and nearer.

In this rapidly expanding field, competitors are scrambling to put their new models onto the market.

exoskeleton

In the beginning of 2015 FDA announced that power exoskeletons will be classified as Class II devices with Special Controls, which clarified the regulatory situation for these kinds of wearable devices. The special controls have been put in place to address a number of risk factors identified by FDA to be associated with the usage of powered exoskeletons.

For those used to medical device development, both the risks as well as the suggested requirements are straight forward. They include among other things, thermal and electric safety, biocompatibility and the obvious risk of falling to the ground.

To help exoskeleton manufacturers getting up and running with their documentation, we provided the Aligned Elements Exoskeleton Extension Package containing:

  • 9 Potential Hazards (including mitigation strategies) outlined as exoskeleton associated risk factors by the FDA
  • 38 exoskeleton Special Control Requirements deduced from 21 CFR Part 890 Docket No. FDA-2014-N-1903

This will give manufacturers a predefined starting point of setting up their Design History File with the intention of accelerating the documentation effort.

The Aligned Elements Exoskeleton Extension Package is downloadable here: Aligned Elements Exoskeleton Extension Package

 

März 22 2016

2016 seems to become the year when it all comes together. The traditional domination of hardware and pharmaceuticals is being caught up by health-through-information.

With wearables becoming a commodity, the 5G standard approaching fast, enabling a revolution in IoT communication, health apps, electronic handling of prescriptions and patient dossiers, health becomes more and more about collecting, analyzing and acting on data.

E Health Data

The digitization of medical device products will have a profound effect on the way the industry conducts business and generates growth.

However, according to McKinsey, medical device companies have been slow to adopt, not necessarily when it comes to what they produce but rather how they produce it. I am often surprised to see how the digitization of the medical devices themselves rarely are matched by an equal digitization level of the development processes.

Ironically, the medical device industry, with its well-known dilemma of being required to provide high-quality innovative products in a regulated market is an exceptionally good candidate for process digitization.

The documentation requirements on a medical device manufacturer are both growing and changing, forcing the development effort to become increasingly focused on the paper trail. 

For safety reason, compliance rightfully requires each step and decision to be carefully recorded. Even though being a just and fair requirement, the operational reality of such a process unrelentingly divides the attention of a professional R&D work force from innovation to administration. A traditional paper-based approach is simply not up to the task of managing the interconnected nature of the DHF. 

Digitizing the development documentation process and rely on a unified repository for the design history file management will not only increase the efficiency of the work and free up valuable innovators from menial documentation tasks. It also makes it possible to automatically analyze and verify the completeness and consistency of the DHF artifacts, increasing the quality of output.

With a medical device ALM like Aligend Elements, allowing the digitization of work practices and document handling, the medical device manufacturer will match the innovation of his products with the efficiency of his processes.

Aligned Elements supports facilitating capabilities like:

  • Electronically sign and release document
  • Automatically route documents according to a workflow process
  • Push released documents to external systems
  • Collaborate on the documentation creation, management and review
  • Perform real-time consistency checks at any time
  • Synchronize documents and generate traceability tables with a single click

Read more about Aligned Elements here.

März 11 2016

What's New

Performance Improvements

This release brings a host of performance improvements, making Aligned Elements data load faster and make your day-to-day work a lot smoother. Quicker loading of the Trace Explorer content and Project explorer books will allow you to concentrate on the moe important tasks at hand.

icon-stopwatch-blue-big

 

Usability Improvements

Use drag and drop to add images and files to the Rich Text and Table attributes. Use menu quick links to add symbols to your texts. Use key-combinations to get your prefered AE hyperlink content. Fewer clicks to accomplish your daily documentation tasks.

DragAndDrop

 

Improved Signing Experience

List your pending signature tasks with a single click. Electronically sign single or multiple documents with a simple point and click. 

 

images

 

What's changed

  • Web client Clear Suspect Traces support added
  • Web client Synchronization of Word files support added
  • Expanded Double attribute options
  • Expanded Copy To File workflow options

 

Upgrade Now

With more than 60 enhancements, fixes and usability improvements, this release is a recommended upgrade.

Find the installer to Aligned Elements V2.3 Service Pack 5 here.

Januar 12 2016

With the Hotfix Aligned Elements V2.3 Service Pack 4 (2.3.52.11241) we have fixed a small number of bugs.

Note that these issues do not pose any danger to the data integrity of the projects. It is only a matter of fixing performance and usability issues that have a negative impact on the Aligned Elements user experience.

Dezember 26 2015

What's New

Cloud Deployment

If you don't have the required skills and resources for installing and managing your own IT infrastructure and software, consider using Aligned Elements cloud option. With a cloud option, you can get up and running quickly while simultaniously keep down costs for IT infrastructure and reduce deployment risk. 

Cloud

 

 

Fast and Flexible Word Reports

Create and update Word reports even faster. Generate template-based Word reports on-the-fly with customized look and feel, create and populate Word documents with two simple clicks or update your documents with the latest database changes without even opening Word!

print2

 

Simple signing with electronic signatures

Collecting document signatures is a final mandatory step when compiling medical device development documentation. A simple but often tedious action since finding the right signees at the right time can be a challenge in today's dynamic environment. Use Aligned Elements e-signatures to send e-signature invitations to the signees. They are just two clicks away from completing their signature.

 

sign3

 

What's changed

  • Web client Display Snapshot support added
  • Web client Word document creation and synchronization added
  • Web client Electronic signatures added
  • Web client Batch editing support added
  • Web client Export functionality added
  • New Project information placeholder 
  • Absolute mitigation reduction calculation
  • Support for Word 2016
  • Support for Windows 10

 

Upgrade Now

With more than 100 enhancements, fixes and usability improvements, this release is a recommended upgrade.

Find the installer to Aligned Elements V2.3 Service Pack 3 here.

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