Aligned Elements Product News

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.

e-signature-blue

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.

October 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

 

April 15 2016

With the 2015 update of the IEC 62366-1:2015 and the issuing of the FDA  Human Factor Guidance, usability engineering in medical device development has received increased attention recently.

Human factor analysis gets more important with the rising trend of offering patient-centric solutions via new mobile health applications and wearables.
When patients, rather than specialists become the medical device user, increased focus needs to be placed on the patients capabilities and the environment in which the device is used. IEC 62366-1 is applied in an effort to increase patient and user safety by identifying, assessing and mitigating Use Errors, by paying attention to the usability of the device design and harness existing usability verification and validation methods to make sure that usability requirements are met and use errors are avoided.

usability

For medical device manufacturers with limited previous experience in usability engineering, the task of implementing IEC 62366-1 might seem intimidating. However, the updated 2015 version of the standard has simplified and clarified the required process steps and tasks and Aligned Element now features a preconfigured setup that integrates the inputs, outputs and risk relevant elements of the usability process into the oveall Design Control traceability.

The configuration includes:

  • 8 Design Control templates for capturing the input and output elements of the usability process
  • Pre-configured content validation checks assessing the consistency of the project in real-time
  • ISO 14971 compliant risk management to identify, assess and mitigate Use Error-driven risks
  • Interactive Checklist for reviewing the Use Specifications Document against IEC 62366-1:2015 
  • 20 usability example risks for Use Errors during the Transport, Storage, Installation and Decommissioning
  • 2 preconfigured Traceability Tables
  • Integrated test protocols for established test methods such as:
  • Cognitive Walkthrough
  • Heuristic Evaluation (based on the Nielsen-Schneidermann heuristics)
  • Simulated-Use Testing for Usability Validation

On top of all that, the Aligned Elements IEC 62366 includes all the standard features of Aligned Elements, including:

  • Completed change control of all Design Control Items
  • Complete audit trail for all changes
  • Keep your company specific look and feel of all report outputs
  • End-to-end tracability with real-time impact analysis
  • Easy and fast Word reporting using drag and drop
  • FDA QSR 21 CFR Part 11 compliant User Management
  • Efficient decision-making process using workflows and E-signatures


By applying selected parts of the Aligned Elements IEC 62366-1 configuration to your Aligned Elements setup, you can efficiently leverage Aligned Elements in your IEC 62366-1 compliance effort.

The Aligned Elements IEC 62366 configuration is available for download in our extension library.

For a live demonstration of the Aligned Elements IEC 62366 configuration, please This email address is being protected from spambots. You need JavaScript enabled to view it. to set up an appointment.

March 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.

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