Aligned Elements Product News

July 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.

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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.

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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.

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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.

June 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?

This email address is being protected from spambots. You need JavaScript enabled to view it. 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

 

May 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.

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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.

March 14 2017

What's New

We are proud to have our customers bring you Aligned Elements 2.4. This release includes some of the top voted features requested by the Aligned Elements user community. We hope you enjoy them!

Managing Test Runs

Plan and Manage Verification and Validation Tests in Test Runs.
Get full overview of Test development and immediate feedback on Test Progression.

Test Management

Parallel Testing of Configurations

Assignment of Test Responsibilities

Test Run Progress Status Indicator

  

Organize with Tags

Apply tags to organize your Design Control Items by categories.
Activate Tag filtering in the GUI to work with the items that concern your current work.

Tag

Filter GUI on Tags

Perform Queries on Tags

Tag over multiple types and projects

 

Electronic Signatures Improvements

Electronic Signatures can significantly streamline the signoff and release process.
Base on customer feedback we have added a host of new signing improvements.

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Electronic signatures without Digital Certificates

Customize Signature location and page

Optional inclusion of Document Information

 

Azure Cloud Server Deployment

The Aligned Element Server can now be deployed in the Microsoft Azure Cloud.
Minimize your IT burden by using our hosted solution.

Cloud

Minimize your IT Infrastructure

Aligned Elements configuration stored in secure cloud File storage

A faster way to get up and running

 

 

What's changed

  • Dynamic Word Reporting in the Aligned Elements Web Client
  • Word Report Performance and Reliability improvements
  • New Inconsistency rules and rule options
  • Enhanced DHF Index support
  • Trace table columns based on Queries
  • Use larger range of attributes in integrated External Tickets
  • Locking of Design Control to prevent changes at certain stages
  • "Backlink" support in integrated External Tickets
  • SQL Server 2016 support

 

Upgrade Now

With more than 200 enhancements, fixes and usability improvements, this release is a recommended upgrade.

Find the installer to Aligned Elements V2.4 here.

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