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

January 30 2015

As an example of Aligned Elements project consistency control, the Aligned Elements Pre-Submission checklist demonstrates how various aspects of the project content can be analyzed in order to avoid failed audits and unwelcome FDA 483 warning letters.

Both EN/ISO 13485 and EN/ISO 14971 are concerned with the completeness and consistency of the project content and this checklists serves as an instrument to make that effort easier and faster.  

The checklist guides the user through a number of analysis action steps and optionally records the results in a checklist report, which serves as objective evidence of the analysis. Detailed instructions and screenshots accompanies the steps to facilitate the execution.

The checklist has been designed to check a project that uses the Aligned Elements default templates.

The checklist verifies test points such as:

  • Have all the Requirements traces to Specifications?
  • Have all Specifications been tested?
  • Are all Tests passed?
  • Have all Risks been mitigated?
  • Have all Mitigations been either tested or traced to a Specification?
  • Have all Document Objects been placed in Word files?
  • Do any Word files contain outdated Document Objects?

The check list further performs optional checks, if you have selected to use features such as:

  • The integrated Issue Management System
  • The integrated Design reviews
  • The integrated Risk Summary
  • The integrated DHF Index

 The Checklist, which is implemented as a Regulatory Wizard, is available for Aligned Elements users on the Extensions page in the Wizard section. 

January 29 2015

"If it is not documented, then it has not been done", according to the FDA saying. "Documentation not available", or "Documentation not adequate" are most frequently cited deviations in FDA Warning Letters. The effects of inconsistent documentation can be devastating, implying postponed market launches, product withdrawals and fines.

The reason for this flood of FDA 483 warning letters, addressing seemingly obvious and simple errors, is not that the medical device manufacturers are ignorant or incompetent.

It is simply hard to keep the DHF documentation consistent. 

The documentation requirements are many and detailed, the development projects often spans over a long time-period, involves a large number of alternating team members, all contributing to the large set of deliverables that make up the Design History File / Technical File. The deliverables are highly interdependent and a small change can cause unexpected ripple-effects over large parts of the documentation.   A considerable amount of the total project effort is thus placed in the handling and management of the DHF.

Not long ago, I was contacted by a customer. He had recently taken over a project with the objective to take the product to market. After a brief introduction, he found the project to be in a miserable state. The project had switched project manager four times during the last four years, the team members were all new, knowledge about the documentation process was lacking.

 In short, the situation was very opaque. 

The project manager wanted help with assessing the current state of the development documentation and within 10 minutes, we could extract the following information from Aligned Elements:  

  • About 20 Requirements lacked traces to Specifications. They were all software related and entered by the same person during a short time-span about two years ago.
  • All Specifications had adequate Test Cases assigned.
  • About 10 Test Cases had never been executed. None of these were functional Test Cases and they had all been entered after the last milestone.
  • About 10 Test Cases had the current state "Failed". Most of them had to do with reliability, maintenance, spare-parts and life-time tests.
  • About 15 Risks were insufficiently mitigated.
  • About 10 Mitigations were not verified or implemented.
  • All Word documents were up to date.

The project manager finally felt that he had some grip of the situation. He now had concrete errors to fix and also the names of the people to contact to get detailed information about each individual inconsistency. 

Design History File - DHF

Aligned Elements addresses the issue of incompleteness with a range of integrated and automatic consistency and control functions. Aligned Elements is able to:

  • In real-time, highlight any gaps and inconsistencies on any content set in the project.
  • Provide reports that present a clear overview of the current consistency state of the project.
  • Guide the user through a predefined process path to make sure errors are not created in the first place.

Coverage 

By the application of configurable validation rules, real-time checks can be executed on the documentation continuously. Faults and gaps are uncovered well in time before the auditor arrives or before the documentation is submitted to the notified body. 

Knowing the state of the development documentation is invaluable for a medical device manufacturer. The list of open errors, representing the project’s “Documentation Quality Debt”, is an excellent estimator for how much work remains until the documentation is ready for release.

Reducing project risk by making the current documentation state transparent is an excellent way to increase the chances of a successful product launch. 

Learn how Aligned Elements can help to organize your Design History File

Schedule a live demo and let us show you how Aligned Elements keeps your DHF complete and consistent

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.

January 19 2015

What's New

Trace Table Designer

Design on-the-fly trace tables directly in the Aligned Elements clients.
Run and inspect immediatly or export and employ design as Trace Table Word Templates.

TraceTable1

 

Flexible Workflows

Flexible, customizable workflows to with rules and conditions to match your existing Quality Management System.
Improves collaboration, enhances process quality and automates business processes.

Workflow

 

Email Notifications

Keep in synch with the team progress by subscribing to changes to any Document objects.
Automatic email notifications to assignees to increase collaboration and accountability.

Mange

 

What's changed

  • SQL Server 2014 compatibility
  • Web client Risk Management editors
  • Web client Trace Table Designer
  • Web client Query Designer
  • Mitigation sorting on Risk Reduction Type in FMEAs
  • Support for “Probability of Harm” and “Probability of Occurrence” in Risk Analysis
  • Export of old Document Object revisions
  • “Change comment”-query filter

 

Upgrade Now

With more than 90 enhancements, fixes and usability improvements, this release is a recommended upgrade.

Find the installer to Aligned Elements V2.3 here.

January 19 2015

Our friend Dr. Samuel Fricker, assistant professor at Blekinge Institute of Technology, is co-authoring the publication "Requirements Engineering for Digital Health".

Requirements-engineering-for-diginatl-health

According to the information, this book:

  • Includes practical step-by-step guidelines, examples, and lessons-learned
  • Addresses domains of central importance for the aging society
  • Bridges cutting-edge research and relevant business and engineering practic

Samuel provided valuable help when we compiled our report on "Requirements Engineering for Medical Devices".

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