Aligned Elements Product News

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.

March 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.

January 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.

December 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.

July 03 2015

The "IEC 62304 – medical device software – software life cycle processes" is a standard specifying life cycle requirements for the development of medical software and software within medical devices. 

This international standard is harmonized by the EU and USA and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.

Software development according to IEC 62304 is a risk-driven approach, requiring the developer to perform reliability- and safety enhancing actions and tasks proportional to the risk the software poses to the patients and users.

Getting compliant with IEC 62304 may seem daunting at first. The Aligned Elements IEC 62304 configuration has been set up to guide you through this process and has been tuned to automatically take care of most of the involved quality checks, making sure that the required tasks and actions are sufficiently covered.

The Aligned Elements IEC 62304 configurations contains:

  • Pre-configured templates using IEC 62304 standard naming conventions
  • Software Safety Classification automatically based on risk analysis results
  • Numerous quality checks for consistency verification
  • Pre-configured Reviews and checkpoints according to IEC 62304 stipulations
  • Pre-configured Trace Tables based on the IEC 62304 requirements
  • Included Process-checklists for documented verification of process compliance

The Aligned Elements IEC 62304 supports documentation management of:

  • System and Software Requirements
  • Software Architecture building blocks(Software Items, Units SOUPs and segregations)
  • Risk Management using a Preliminary Hazard Analysis technique (listed in ISO 14971)
  • Verification and Validation (Unit, Integration and System testing)
  • Change and configuration management (Problem Reports and Change Management)


On top of all that, the Aligned Elements IEC 62304 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 62304 configuration to your Aligned Elements setup, you can efficiently leverage Aligned Elements in your IEC 62304 compliance effort.

The Aligned Elements IEC 62304 configuration is available for download in our extension library.

For a live demonstration of the Aligned Elements IEC 62304 configuration, please This email address is being protected from spambots. You need JavaScript enabled to view it. to set up an appointment.

googleplus facebook