Aligned Elements is a Medical Device application lifecycle management (ALM) solution enabling fast development and regulatory compliance through improved Design History File management.

February 24 2018

Test managers often have to deal with superhuman juggling of timelines, resource allocations and continuously changing specification while facing increasing pressure from management as the shipping-date draws closer. Furthermore, the test manager is responsible for making sure that the traceability is completed, that test data integrity remains intact and that change management procedures are followed correctly, even under situations of extreme stress.

Efficient change management, planning, tracking and reuse of test executions are therefore much appreciated tools in the V&V Managers tool box. The Aligned Elements Test Runs aims to address these challenges. The Test Runs manages the planning, allocation, execution and tracking of test activities. Let's dive into the details.

Planning the Test Run

The Test Run Planning section is the place to define the Test Run context, much as you would write a Verification Plan.

The Test Run Planning information includes:

  • What to test i.e. information the Object Under Test and the addressed configurations
  • When to perform the tests i.e. the planned start and end date for the Test Run
  • Who participates in the test effort i.e. the team of testers and their allocated work
  • How to test the device i.e. which test strategy to use by selecting among the existing test types
  • Why the test is being done i.e. the purpose or reason for performing this particular set of tests on this Object Under Test

Quality Assurance in Aligned Elements

Allocate existing Test Cases from your Test Case library to the Test Run by using simple drag-and-drop. You can use any number of tests of any available types from any number of projects. If needed, add Test Run specific information to the Test Cases and designate the Test Cases to the members of the Test Team.

Once the planning phase is completed, the Test Execution can begin.

The Test Execution phase 

Test Case data is kept separate from the Test Execution result data, permitting a high degree of test case reuse and a clear separation between Test Instructions and Test Results.
Consistency checks are optionally carried out on the Test Case before execution in order to ensure that tests cannot be performed until all foreseen process steps are completed.
During execution, the test input data is optionally kept read-only, preventing testers to modify a reviewed and released Test Case during execution.

All Test Team Members can access the Test Run and simultaneously Execute Tests as well as continuously monitor how the Execution phase progresses.

Test Run Progress Bar

Real-Time Test Execution data is presented through:

  • Individual Test Execution results including any found defects as well as colour coded feedback on states
  • Colour coded test progression statistics, with possibility to drill down on e.g. individual Testers or Test Types
  • Burn down charts, showing how planned Test progress over time corresponds to the actual progression

Defect Tracking

During Test Execution, Defects and Anomalies can be created and traced on-the-fly without having to leave the Test Execution context. The Defects can be tracked in either Aligned Elements internal Issue Management system or already existing integrated Issue Trackers such as Jira, TFS, GitHub, Trac or Countersoft Gemini or any mix of these systems. Created Defects and their corresponding status are displayed in the Test Run.

TestCaseList

Test Case Change Management

When developing medical devices, it is of paramount importance to keep your Design Control under tight change control.
The Test Run assist the testers and test managers in several ways to accomplish this goal, including optional actions:

  • Preventing inconsistent tests from being executed
  • Preventing input data to get modified during test execution
  • Allowing Test Managers to lock/freeze Design Input and Tests during execution
  • Alert testers when attempting to modify tests for which valid results already exist
  • Signalize weather a Test Case has been reviewed and released or not
  • Allowing the user to explicitly invalidate existing test results when a test is updated with major changes

Testing Variants of the Object Under Test

If several variants of the Object Under Test exist, it is sometimes desirable to create variant specific test results for common test cases and subsequently create separate traceabilities for the variants. The Test Run uses a concept called "Configurations" to achieve this behaviour. A Test Case is executed for one or more Configurations to make sure that variant specific test results are kept separate.

The exact data composition of a Configuration is customizable to fit the needs of each customer.

Complete the Test Run

Once all Test Cases has been completed, the Test Run and all its content is set to read-only. Optionally, a Snapshot of all Test Run relevant items is created as part of the completion procedure. A Test Run report containing all the necessary Test Run information can be inserted into any Word Document using Aligned Elements Word Integration with a single drag and drop action.

The Test Run is a Test Managers best friend, providing the flexibility needed during test planning and full transparency during test execution, making it possible to quickly react as real time test events unfold.

Note: Burn Down Charts is under development at the point of writing and planned to be released in the next service pack.

November 21 2017

Last week we met up with some of the Swiss Aligned Elements users at the Aligned Elements User Conference 2017. It was a very rewarding occasion for me and our team. For ten years, we have grown together with our customers and many of the best improvements we have done to Aligned Elements, are ideas from our customers.

It is not always about new features

It is easy to get locked into the thought process of adding new features as an ISV. However, this user gathering underlined how much unlocked potential lies in slightly tweaking existing features, features that might not look very impressive on the surface but still has an enormous impact on the usability due to its frequent use. For us it was a real eye opener to hear about the large impact of two small features called "Reset Format" and "Paste as Plain Text". The participants had some good suggestions for improvements that we certainly will implement for the next service pack.

Different Users have different needs

As the discussion went on, it became clear that the needs of the groups "Frequent Users", "Infrequent Users" and "Administrators" are quite different. Whereas the Administrator representatives requested better support for User Management and changes made over large Project sets, the Infrequent Users were in greater need of clearer work instructions and an interface adapted to their specific tasks. One user compared Aligned Elements with Photoshop, "if you are a power user, Aligned Elements is extremely powerful, but if you only log in every six months to tick of tasks assigned to you, the interface is intimidating and do not do much to guide this user." We have great ideas in this area that we hope to be able to include in our next version.

Follow that document

Several users pointed out that Document Management, Review, Release and Sign-off actions have potential for improvements, both in scope and implementation details. This is something we are aware about and the user feedback delivered during the conference was very helpful on these points.

We are grateful to the participants for having joined this year's User Conference and will do our best to incorporate the improvements and suggestions in future Aligned Elements releases.

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.

September 12 2017

Cybersecurity issues resulted in 465 000 St Jude pacemakers being subjected to a FDA recall due to fears of exploiting existing cybersecurity vulnerabilities in the device. A security hole exposes the device to hacking risks, potentially resulting in running the batteries down or even alter the patient’s heartbeat.

pacemaker

Although the risk is extremly low, the cost for St Jude / Abbott is significant. For a smaller firm these ramifications can be detrimental. The long life time of medical devices and an ever evolving cybersecurity arena makes devices vulnerable to cyber risks. Handling them effectively will be a significant challenge for the industry in the years to come.

We are addressing Cybersecurity issues in the Supply Chain during a Key note at the Swiss Medtech Expo in Luzern, 19-20 September.

Join us for this key note or come and meet us at the Expo at Booth B2045, Halle 02.

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