Aligned Elements Product News

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. 

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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!

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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.

 

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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.

May 27 2015

What's New

Document Management System integration

Automatically push updated, synchronized and released DHF documents from Aligned Elements into your Document Management System. Aligned Elements workflow actions push documents from Aligned Elements to a designated file location of your chosing. The push action includes optional PDF conversion, dynamic file name strategies and transfer of document meta data.

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Efficient Test Case Execution

Create and assign bugs and deviations to individual test points / test rows without having to leave the testing context. Seamlessly use your existing issue tracking system, be it TFS, JIRA, Trac or Gemini, from inside Aligned Elements' test execution environment.

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External links

Use the Aligned Elements specific URL:s to reference Aligned Elements Document Objects outside the application. The URL is a clickable link that can be used in emails, on the web or in Office documents to designate individual Aligned Elements Document Objects. Click on the link to automatically open the Document Object in Aligned Elements.

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What's changed

  • Web client User Management support
  • Web client Project Settings support
  • Web client Snapshot setting functionality
  • Web client export of Word and Excel reports
  • Web client Document Object unlock support
  • New inconsistency rule: Missing Trace From
  • New inconsistency rule: Is Test Executed from last Revision
  • Checkbox, Dropdown, Datetime, User and Multiselect columns in Table Attributes
  • Set traces to individual rows in Table Attribute
  • Save and reuse company customized word formats in Richtext and Table attributes
  • Batch execution, generation and copying of Document Objects
  • Discontinuation of Word 2003 support

 

Upgrade Now

With more than 130 enhancements, fixes and usability improvements, this release is a recommended upgrade.

Find the installer to Aligned Elements V2.3 Service Pack 2 here.

January 23 2015

With the Hotfix Aligned Elements V2.3 Service Pack 1 (2.3.2.10145) we have fixed a small number of crucial bugs fixing some serious inconviniences in Aligned Elements V2.3.

Note that these issues in Aligned Element do not pose any danger to the data integrity of the projects. It is only a matter of fixing GUI problems that degrades the usability.

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