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

October 31 2019

Computer Software Validation is something we discuss a lot where I work. Since Aligned Elements is a Medical Device Quality Management System relevant software, our customers make sure that their Aligned Elements installations and configurations are validated.

It is a necessary activity, although not always perceived as bringing an awful lot of value. Sometimes the cost of CSV activities actually supersedes the cost of acquiring the software itself. 

I sometimes get the question if I know any best practices when it comes to Computer Software Validation and I have made a few observations from my CSV experiences. 

Let me tell you about the top 3 things that has an impact on the Computer Software Validation effort:

1) How many test cases do you perform?

It is dead simple. More test cases (note: not necessarily "more requirements") is more work. But do YOU have to perform all those test cases? What if the supplier has already verified them? 

You are very much allowed to leverage existing supplier documentation and testing records. A properly conducted Supplier / Vendor assessment can lead you to the conclusion that the suppliers verification documentation suffice. Remember that the risk we are trying to mitigate with a Computer Software Validation effort is primarily about patient safety. A software like Aligned Elements is not directly involved in the patient safety and this fact can be leveraged when assessing and deciding on the validation scope. 

2) How do you record the test results?

The bulk of the CSV work resides in performing and recording the test results. The way you record those results can have a significant impact on the overall effort. In order to record that the actual behavior of a test step corresponds to the expected behavior, is it enough to tick a box (passed/failed)? Or do you need to write a text? Or do you need to make screenshots? As you can imagine, there is a huge difference between the former and the latter.

"But are we not required to take screen shots?".  The short answer is "No, you don't". Not if you do not think it proves anything more than the tester checking a box. FDA requires you to select your own methods and tools for quality assurance. If you have a good case for not making screen shots (which I think you have), you do not have to.

3) Who (and how many) has to sign all these CSV documents?

This might sound a bit odd but more than once I have run into cases where the validation is completed and everything that is missing is a signature from some top management figure. And now we run into a buy-in problem. If this guy has not been involved CSV approach and suddenly disagrees with how it was conducted ("BUT THERE ARE NO SCREENSHOTS?!?"), it can have a significant impact (significant as in "redo the validation").

So the lesson here is to get early buy-in from the people that sign the document. On a general level, reducing the number of signatures will speed up any documentation process. And you might want to contemplate on the necessity of having the IQ, OQ and PQ plans / reports in different documents (more documents to sign) or if you can combine them.

Validating Aligned Elements

When you acquire Aligned Elements, you get free access to our internal verification documents to use in your vendor assessments as well as pre-filled Validation documents to kick-start your validation. Contact us for more information on This email address is being protected from spambots. You need JavaScript enabled to view it.

What's up ahead regarding Computer Software Validation?

FDA announced that their much anticipated "Computer Software Assurance for Manufacturing, Operations, and Quality System Software" draft guidance should be out in 2019 but now it seems like it has been postponed to 2020. The new guidance is supposed to use a more agile approach, including a risk-based and value creating perspective on CSV activities.

 

September 23 2019

What's New

Aligned Elements V2.5 SP 1 is a service pack consisting almost exclusively of bug fixes. 

What's Changed

  • Web Client optionally authenticates against Active Directory
  • Improved security mechanisms in Web Client
  • Improvements for Linked project handling in Web Client
  • Fixes in the Web Client Word Document Handling

Upgrade now

With important fixes, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 SP 1 here.

August 14 2019

It is a well known tendency that changes made to software (new features, bug fixes etc.) often leads to new software errors. In a medical device context, this can have detrimental consequences.

The FDA requires that medical device manufacturers submit a new 510(k) when a marketed devices has changes, including changes to software, that could significantly affect the safety or effectiveness of the device or when there are major changes in the intended use of the device.

Of course, the word "significantly" is the moving target here. To facilitate the decision whether a new 510(k) is required, the FDA issued the guidence document "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" in October 2017.

FDA Commissioner Scott Gottlieb said a statement that the guidance ..."enhance predictability and consistency for innovators deciding when to submit new 510(k)s by better describing the regulatory framework, polices and practices underlying such a decision.”

Aligned has published an Aligned Elements Regulatory Wizard called When to Submit a 510(k) for a Software Change to an Existing Device that codifies this guidance document and makes it easy to asses and document whether the software changes (captured and managed in Design Control Items in Aligned Elements) will result in a new 510(k) or if documentation thereore suffices.

SoftwareChanges

The wizard When to Submit a 510(k) for a Software Change to an Existing Device is freely available for download from the Extension section of this website and serves as yet another example of how Aligned Elements can reduce the development documentation effort of your device.

 

June 27 2019

What's New

Aligned Elements V2.5 is here and brings a host of new enhancement and fixes. 

 

Branching and Merging Projects

Branch Aligned Elements projects to enable parallel development throughout the Product Development Life Cycle. For example, when V1.0 of your device has been released, branching the project ensures that your next release V2.0 can be developed in parallel with any fixes required to V1.0. Merge features back from a branch into the mainline with a few simple clicks.

 

Branch

 

Native Word Integration from Aligned Elements Web Client

The Aligned Elements Web Client now provides a native Word Add-In which makes it possible to an incredibly flexible report creator, freely mixing regular Word Content with Aligned Elements content. All Word Integration features available in the Aligned Elements Windows client are now available in our Web Application as well. Select a Document in Aligned Elements and Word will automatically start with the Word Add-In displayed on the right side of the Word application.

 

WordAddIn

 

Risk Assessment Improvements

Upon customer request, we have expanded the range of options available for configuring Risk Assessments, including Probability and Severity text dropdowns, unlimited number of risk zones with customizable coloring and fully customizable risk result presentation.

 

risks

 

What's Changed

  • Automatically pre-populate project with content at project creation
  • Dynamic List Attribute - expand selectable items range from GUI
  • Group Test Runs
  • Group User Favourites
  • Filter Office Explorer on Tags
  • Workflow action: Generate Object
  • Enhanced Security
  • Incoming suspect Trace validation rule
  • Validation on Incoming Trace rule
  • Illegal Trace From validation rule

Upgrade now

With important fixes and a handful improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 here.

April 07 2019

 

Sharpen your Skills 2019

May 21st, 2019 | HWZ University, 3 minutes from Zürich Main Station


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Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2019.

We have called on a group of experienced industry expert to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to see you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

REGISTER NOW!


Key Learning Objectives

The way to MDR: real world experience

The MDR transition window is closing. Manufacturers, Notified Bodies, and Distributors are working vehemently to reach the opposite shore in one piece.
An excerpt of the experience of adapting to these new requirements, including hints and best practice are presented in this session.

Presented by: Hansjörg Riedwyl, CEO, ISS AG

Hidden cost drivers in clinical investigations - the importance of strategy

Market access and approval is more dependent than ever on clinical data. Getting your clinical trial design right, in time and within budget, is one of the most important steps.
This session focuses on the importance of collaboration with regulatory and clinical operations experts to minimize the risk for delays as well as the costs.

Presented by: Carin Nilsson, Partner, Confinis CPM

Computer System Validation CSV – between ZERO and HERO

How to best handle the conflicting expectations from Management, IT, Quality Department and (last but not least) the Auditor?
Gerhard Dariz provides deep, real-world insights from corporate practice and show possible strategies to survive this area of tension.

Presented by: Gerhard Dariz, CEO, Inmedis GmbH

Clinical Evaluation and Post Market Clinical Follow-Up under MDR

MDR introduces important changes in expectations on how to demonstrate device safety and performance prior to market access.
This session provides an overview and hands-on examples of the Clinical Evaluation and Post-Market Clinical Follow-Up processes under the MDR.

Presented by: Dr. Autumn Lang, CEO, Confinis CPM

Automated Design Control Documentation

Machine Learning. Digitalization. The future holds a promise of machines performing more and more of our daily tasks. However, many of us are still putting Design Control Documentation together character by character. Can the Design Control Documentation be automated? What would that look like? What are the limitations?

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG


Time and Place

  • Date: Tuesday May 21st
  • Time: 08:15 - 13:30
  • Place: HWZ University, Zürich

Presentations are held in German. Slides written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel and other industry professionals engaged in medical device development.

Registration

We are looking forward to see you at this seminar!

Registration Fee: 125 CHF

30% early bird discount for registration before May 1st.

REGISTER NOW!


Location

Address: HWZ Hochschule für Wirtschaft Zürich, Lagerstrasse 5, Zürich

HWSMap

 

About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 HTCS

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