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

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.

February 09 2017

One audit to rule them all. 

Sounds good, doesn't it?

ring

If you have spent a lot of time in audits lately, then you are certainly not alone. More and more company resources are devoted to a continuous string of auditing activities. The Medical Device Single Audit Program is an initiative by the IMDRF intended to curb the audit avalanch.  

But does the promise hold? Or is it too good to be true?

Read this inside story from a recent MDSAP audit experience.

February 09 2017

Our friends at Qadvis has grown steadily over the last couple of years and this is no wonder.

qadvislogo

These guys are co-authors of many of the standards you use today. If you have questions about ISO 13485, IEC 62304, IEC 80001-1 or IEC 60601-1, who would be better to ask than the person who actually penned it? 

I can highly recommend their services and advice. Just recently the Qadvis Team put together a ton of Quality and Regulatory material for download on their website. For free!

Go take a look!

 

November 17 2016

You spend too much time and money on documentation.

Agreed?

Good.

So what is your plan?

The regulations of the medical device industry requires us to produce a pretty hefty chunk of documentation to show that the device is safe and efficient. If the documentation is not compliant, then it does not matter how safe, secure and performant the device itself it. Therefore, the documentation aspect that receives the largest share of attention is compliance. The most common path to a compliant stack of documents is to throw heaps of man-hours at the problem. Quantity seems to be the weapon of choice in many firms.

As a consequence, a large number of people gets involved in the documentation creation and maintenance, especially people residing the R&D part of the organization as most companies do not have Document Officers or documentation experts in their organization.

However, engineers and scientists are not necessarily the best writers (And they probably have no ambition to be.) Staff who are necessary for other tasks struggle to find the time to write tehse documents, and so the documents they do produce may be of lower quality than their usual work.

The effect on these people is often a suffocating feeling of inefficiency and a frustration of spending an un-proportionally large part of the working day on menial documentation tasks, deciphering SOP:S and unpractical standards to compile documents that no-one reads (apart from the auditor).

lifebelt

Our studies show that up to 30% of the total project effort is spent on documentation required by regulations. There is also an overwhelming consensus in the industry that this is a far too much. Money and time is inefficiently spent and morale buckles as the workload increases.

The good news is that these problems can be fixed. The bad news is that you are going to lose time, money and people until you fix them.

Excelling at documentation efficiency is not intuitive to many R&D-centric organization. However, considering the situation described above, good documentation practices is an investment. In the medical device industry, it is even a competitive dimension.

Your company can be efficient!!

Some good starting points are:

  • Make documentation efficiency a prioritized objective using measurable goals
  • Assign a responsible Manager
  • Set up a tight collaboration between the people writing templates and SOPs (Quality people) and the people using the templates and SOPs (R&D people)
  • Analyze your documentation processes
  • Apply the right software tools to automate documentation tasks

You can start right away!

Download our Medical Device Documentation Self-assessment paper and take a few minutes to complete it. We assure you that you will have started the road to a more efficient documentation within the next 15 minutes!

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