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Aligned Elements V2.4 SP 3 Released

What's New

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Continued integration with external systems has been the theme of this release. We are glad to have incorporated GitHub tickets into 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.

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Web Client Usability

Improved linked project support, as well as the display of Help Texts, have been implemented in this release.

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Starting external processes

Via Workflows, it is now possible to start external processes, triggered by events in Aligned Elements. These external processes can be fed with Aligned Elements content for further processing.

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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 handful of improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 3 here.

Aligned Elements V2.4 SP 2 Released

What's New

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In this release, we have continued to expand existing features in alignment with our customers' feedback. Charts are now persistent, the Web client is getting really smooth and the powerful Test Run gets even more powerful.

Charts

Although charts have been a feature of Aligned Elements for quite a while, you can now save them and integrate them into your Word reports. The Chart Designer lets you design and organize your charts and present the project's Design Control data in the most capturing way.

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Web Client Usability

We have included popovers of Document Objects when hovering on Document Object IDs in the Web Client. This gives a quick preview of the item's content without having to leave your context.

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Test Run Improvements

Test Runs have been enthusiastically received by the Aligned Elements User community. In this release, we have added newly requested features, improved performance, and fixed a number of bugs.

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What's Changed

  • Two new Inconsistency rules
  • Signalize suspect traces across project boundaries
  • Improved import mapping capabilities
  • Improved reliability and performance for Word Reports
  • Additional DB security options- Chapter content optionally displayed as lists

Upgrade now

With more than 100 enhancements, fixes, and improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 2 here.

Medical Device Cybersecurity Risk Management

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Performing Medical Device Cybersecurity Risk Assessments is something we Medical Device Manufacturers must get used to. And the sooner the better, During 2016 and 2017 a mounting number of health associated cybersecurity incidents have been reported. Cybersecurity breaches may well become THE main safety concern in our industry within the next few years. Increased regulation on this matter is to be expected.

Hacking

FDA has already published guidelines on its view on how medical device manufacturers ought to address cybersecurity in Medical Devices. The guidance outlines the documentation FDA expects to see in the premarket submissions as well as what is expected to be conducted for SOUPs and during postmarket activities.

At the core of this documentation lies the Cybersecurity Risk assessment. As already discussed, this type of risk assessment is slightly different to the typical Design Risk Assessment conducted during development.

To address this task, which many manufacturers will have to perform, we have developed a risk assessment template set specifically for documenting Cybersecurity risks and mitigations.

This template package is free to download and use for all Aligned Elements customers.

Are you interested in how the Cybersecurity Risk Assessment can be conducted and integrated with the rest of your Design Controls?

This email address is being protected from spambots. You need JavaScript enabled to view it. for a free demonstration!

The Aligned Elements Cybersecurity Risk Assessment package contains:

  • Risk assessment templates based on AAMI TIR 32, modeling Assets, Threats, Vulnerabilities and Risk Controls as Measures
  • More than 30 Best Practice Cybersecurity Risk Mitigations ready to use

If you are looking for a Cybersecurity Risk Assessment Word Template, you can download an example here:

Cyber Security Risk Assessment Word Template

 

Kickstart your Technical File with the EU MDR General Requirements

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On May 5th, the final texts of the MDR (Regulation EU 2017/745) and the IVDR were published in the EU Official Journal

It's quite a chunk of text and if you have not yet started to update your Quality Management System, SOP:s, and Technical Files, you should (seriously!) take some to plan these actions accordingly.

 MDRJournal

The EU MDR 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 checklist here:

MDR (EU 2017/745) Annex I General Safety and Performance Requirements Checklist

The MDR Annex I General Requirements are also available to Aligned Elements users as a free extension. This means that the MDR 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 37 page checklist and is made readily available in your traceability in a matter of seconds!

The MDR Annex I General Requirements extension is yet another of the many available free extensions available to Aligned Elements users which 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: MDR (EU 2017/745) Annex I Extension

Aligned Elements V2.4 SP 1 released

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 provides fixes to the integration mechanisms 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.

Aligned Elements V2.4 released

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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 a 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.

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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 a 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.

How to document a powered Exoskeleton according to the FDA

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A few years ago we could read articles claiming "Exoskeletons will one day replace wheelchairs". That the FDA regulates these kinds of devices is a clear sign that they are about to enter the mass market.

Miniaturization of electronics, a steep drop in manufacturing costs of mechatronic parts, increased computational power, more powerful batteries. A number of recent technical developments converge into the realization of exoskeletons growing nearer and nearer.

In this rapidly expanding field, competitors are scrambling to put their new models onto the market.

exoskeleton

In the beginning of 2015 FDA announced that power exoskeletons will be classified as Class II devices with Special Controls, which clarified the regulatory situation for these kinds of wearable devices. Special controls have been put in place to address a number of risk factors identified by the FDA to be associated with the usage of powered exoskeletons.

For those used to medical device development, both the risks as well as the suggested requirements are straightforward. They include among other things, thermal and electric safety, biocompatibility, and the obvious risk of falling to the ground.

To help exoskeleton manufacturers getting up and running with their documentation, we provided the Aligned Elements Exoskeleton Extension Package containing:

  • 9 Potential Hazards (including mitigation strategies) outlined as exoskeleton associated risk factors by the FDA
  • 38 exoskeleton Special Control Requirements deduced from 21 CFR Part 890 Docket No. FDA-2014-N-1903

This will give manufacturers a predefined starting point of setting up their Design History File with the intention of accelerating the documentation effort.

The Aligned Elements Exoskeleton Extension Package is downloadable here: Aligned Elements Exoskeleton Extension Package

 

The Aligned Elements IEC 62366 Usability Configuration

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With the 2015 update of the IEC 62366-1:2015 and the issuing of the FDA  Human Factor Guidance, usability engineering in medical device development has received increased attention recently.

Human factor analysis gets more important with the rising trend of offering patient-centric solutions via new mobile health applications and wearables.
When patients, rather than specialists become the medical device user, the increased focus needs to be placed on the patients' capabilities and the environment in which the device is used. IEC 62366-1 is applied in an effort to increase patient and user safety by identifying, assessing, and mitigating Use Errors, by paying attention to the usability of the device design and harness existing usability verification and validation methods to make sure that usability requirements are met and use errors are avoided.

usability

For medical device manufacturers with limited previous experience in usability engineering, the task of implementing IEC 62366-1 might seem intimidating. However, the updated 2015 version of the standard has simplified and clarified the required process steps and tasks and Aligned Element now features a preconfigured setup that integrates the inputs, outputs, and risk-relevant elements of the usability process into the overall Design Control traceability.

The configuration includes:

  • 8 Design Control templates for capturing the input and output elements of the usability process
  • Pre-configured content validation checks assessing the consistency of the project in real-time
  • ISO 14971 compliant risk management to identify, assess and mitigate Use Error-driven risks
  • Interactive Checklist for reviewing the Use Specifications Document against IEC 62366-1:2015 
  • 20 usability example risks for Use Errors during the Transport, Storage, Installation, and Decommissioning
  • 2 preconfigured Traceability Tables
  • Integrated test protocols for established test methods such as:
  • Cognitive Walkthrough
  • Heuristic Evaluation (based on the Nielsen-Schneidermann heuristics)
  • Simulated-Use Testing for Usability Validation

On top of all that, the Aligned Elements IEC 62366 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 traceability 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 62366-1 configuration to your Aligned Elements setup, you can efficiently leverage Aligned Elements in your IEC 62366-1 compliance effort.

The Aligned Elements IEC 62366 configuration is available for download in our extension library.

For a live demonstration of the Aligned Elements IEC 62366 configuration, please This email address is being protected from spambots. You need JavaScript enabled to view it. to set up an appointment.

Digitization of the Med Tech Industry

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2016 seems to become the year when it all comes together. The traditional domination of hardware and pharmaceuticals is being caught up by health-through-information.

With wearables becoming a commodity, the 5G standard approaching fast, enabling a revolution in IoT communication, health apps, electronic handling of prescriptions, and patient dossiers, health becomes more and more about collecting, analyzing, and acting on data.

E Health Data

The digitization of medical device products will have a profound effect on the way the industry conducts business and generates growth.

However, according to McKinsey, medical device companies have been slow to adopt, not necessarily when it comes to what they produce but rather how they produce it. I am often surprised to see how the digitization of the medical devices themselves rarely is matched by an equal digitization level of the development processes.

Ironically, the medical device industry, with its well-known dilemma of being required to provide high-quality innovative products in a regulated market is an exceptionally good candidate for process digitization.

The documentation requirements on a medical device manufacturer are both growing and changing, forcing the development effort to become increasingly focused on the paper trail. 

For safety reasons, compliance rightfully requires each step and decision to be carefully recorded. Even though being a just and fair requirement, the operational reality of such a process unrelentingly divides the attention of a professional R&D workforce from innovation to administration. A traditional paper-based approach is simply not up to the task of managing the interconnected nature of the DHF. 

Digitizing the development documentation process and rely on a unified repository for the design history file management will not only increase the efficiency of the work and free up valuable innovators from menial documentation tasks. It also makes it possible to automatically analyze and verify the completeness and consistency of the DHF artifacts, increasing the quality of output.

With a medical device ALM like Aligned Elements, allowing the digitization of work practices and document handling, the medical device manufacturer will match the innovation of his products with the efficiency of his processes.

Aligned Elements supports facilitating capabilities like:

  • Electronically sign and release document
  • Automatically route documents according to a workflow process
  • Push released documents to external systems
  • Collaborate on the documentation creation, management, and review
  • Perform real-time consistency checks at any time
  • Synchronize documents and generate traceability tables with a single click

Read more about Aligned Elements here.

Aligned Elements V2.3 Service Pack 5

What's New

Performance Improvements

This release brings a host of performance improvements, making Aligned Elements data load faster and make your day-to-day work a lot smoother. Quicker loading of the Trace Explorer content and Project explorer books will allow you to concentrate on the more important tasks at hand.

icon-stopwatch-blue-big

 

Usability Improvements

Use drag and drop to add images and files to the Rich Text and Table attributes. Use menu quick links to add symbols to your texts. Use key-combinations to get your preferred AE hyperlink content. Fewer clicks to accomplish your daily documentation tasks.

DragAndDrop

 

Improved Signing Experience

List your pending signature tasks with a single click. Electronically sign single or multiple documents with a simple point and click. 

 

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What's changed

  • Web client Clear Suspect Traces support added
  • Web client Synchronization of Word files support added
  • Expanded Double attribute options
  • Expanded Copy To File workflow options

 

Upgrade Now

With more than 60 enhancements, fixes, and usability improvements, this release is a recommended upgrade.

Find the installer to Aligned Elements V2.3 Service Pack 5 here.

Hotfix Aligned Elements V2.3 SP 4 released

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.

Aligned Elements V2.3 Service Pack 3

 

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 simultaneously keep down costs for IT infrastructure and reduce deployment risk. 

Cloud

 

 

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.

The Aligned Elements IEC 62304 configuration

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 pose 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 contain:

  • 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 traceability 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.

Aligned Elements V2.3 Service Pack 2

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 choosing. The push action includes optional PDF conversion, dynamic file name strategies, and transfer of document metadata.

flyingFile

 

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.

Crash

 

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.

Link

 

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.

Hotfix for Aligned Elements V2.3

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 inconveniences 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.

Aligned Elements V2.3

What's New

Trace Table Designer

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

TraceTable1

 

Flexible Workflows

Flexible, customizable workflows 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 sync 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.

Introducing the Aligned Elements Web Client

On July 19th, 2014, we release Aligned Elements V2.2 (2.2.7.9739) which includes the new Aligned Elements Web Client.

The Aligned Elements Web Client enables browser-based access to any Aligned Elements project from any remote location.

Login

 TraceExplorerConsistencyCoverageWebChart

It is an efficient way to involve and benefit from external project stakeholders such as customers, suppliers, distributed marketing teams, external testers, and other remote team members in the Design History File collaboration process.

The web client permits the user to perform core activities such as creating, updating and tracing Document Objects, managing chapter hierarchies, inspecting the project content, running queries, performing free text searches, etc.

The new interface is optimized for easy access to core Aligned Elements functions and combines high performance with a modern interface to enhance the user experience.

For the Windows Client V2.2, we have added a number of new features, most notably:

  • Bookmarking favorite Document Objects
  • Inclusion of the Revision History in Document Object XML exports
  • Optionally including old revision data of Document Objects in Excel reports
  • Copy users to other projects in order to minimize User management effort

We hope that you will enjoy these improvements.

Zühlke: "A highly suitable application for medical device development"

Zühlke Engineering AG in Zürich (http://www.zuehlke.com), has been
evaluating Aligned Elements during the spring and we recently had the
opportunity to speak with Mr. Claudio Schödler, project manager at Zühlke,
about the results.

"Having finished the evaluation of Aligned Elements after 3 months of
careful study, we can conclude that it is a highly suitable application for
medical device development projects." Mr. Claudio Schrödler summarises.

"The tight integration of the risk management functions is a particularly
strong advantage when working in this industry.", Mr.Schödler continues.
"In comparison with other similar applications, we have noted that Aligned
Elements excels in terms of ease of use and reporting. Most teams will be
up and running in a very short time.”

"As you work with the application, it becomes apparent that the Aligned
team has focused on easing the documentation burden, and succeeds in doing so very well.”

Preliminary Hazard Analysis vs. FMEA in Aligned Elements

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From the very first day, we decided to integrate risk management into Aligned Elements. It is obvious to anyone within the industry that risk management and requirement-specification-verification-validation management are intimately connected. Still, many companies insist on keeping these two artefact collections separate in isolated systems. We think the management of all Design Control Items, including risk information, can be made more efficient with fewer errors if they are kept within one system.

Failure Mode and Effect Analysis in Aligned Elements

In Aligned Elements, we initially implemented FMEA as a risk analysis method. The FMEA is a very versatile risk assessment technique. It is widely adopted in the medical device industry and fairly straightforward to understand.

The implementation of FMEA:s in Aligned Elements goes as follows: a Failuremode entity holds a collection of Hazard entities. Each Hazard contains a cause with its probability, an effect with its severity, and an additional optional visibility parameter. A risk priority number is calculated based on the probability, severity, and visibility values. The Hazard can then be addressed with one or more Mitigations which, each in turn, reduce the RPN to a new value. 

All this entered risk information is subjected to Aligned Elements general features, including:

  • Individual IDs assigned to each entity
  • Strict version management of all changes made
  • Changes are registered chronologically in the project audit trail
  • Search and filter options can be applied using the Query Manager
  • Risk reviews can be performed using the integrated Design Review Module
  • The  risk information can be included in the Aligned Elements DHF Index

Based on our experiences of time consuming risk analysis work, we included a number of usability features to make the day-to-day work easier and to save time and resources: 

  • Automatic calculation of RPN
  • Automatic checks of RPN against thresholds
  • Intelligent reuse of mitigations
  • Highlighting of unmitigated risks
  • Highlighting mitigations that have not been implemented
  • Automatic Risk Summary generation
  • Control checks that applicable parts of the DHF have been subjected to risk analysis
  • Highlights which requirements/specifications/tests are affected by the risk analysis
  • Incorporation of risk entities into the overall trace landscape

One of the many reasons the FMEA is such a widely adopted technique derives from its versatility and flexibility. This permits the medical device manufacturer to apply the best possible fit between his risk analysis approach and his existing products, processes, and organization.

Aligned Elements provides a number of customization possibilities to ensure that a wide range of FMEA variants can be applied, including:

  • Customizable naming of the parameters and entities
  • Customizable Probability, Severity and Visibility ranges
  • Customizable thresholds for unacceptable risk, ALARP, and acceptable risk
  • Customizable formulas for RPN calculation
  • Customizable look and feel of the risk report
  • Expanded Risk reports to include traceability to mitigation implementation according to client QMS
  • Multiple FMEA types in the same project

Enter Preliminary Hazard Analysis 

Not all our customers favored the FMEA as a risk analysis method. We, therefore, contacted ProSystem AG,  a renowned expert company in the area of medical device risk management and an active member in several norm groups (such as IEC 62304, IEC 60601-1) and jointly developed a Preliminary Hazard Analysis (PHA) method in Aligned Elements as an effective complement to the existing FMEA method.

According to theory, the PHA is a top-down approach, using a list of known hazards as input for the risk analysis. The PHA method can be applied in the early stages of the development process and does not presuppose detailed knowledge about the system to be analyzed. 

The Aligned Elements Preliminary Hazard Analysis uses terminology aligned with ISO 14971 to describe Potential Hazards, Harms, Measure entities, etc.. 

As opposed to the FMEA, our PHA implementation uses a stricter separation of Causes and Harms from the Risk Analysis aggregator (the Risk Analysis entity corresponds to the Failuremode entity as a collection of Causes and Harms under a particular subject), where Causes and Harms are captured as separate entities. This allows more efficient reuse when causes and harms are reoccurring throughout the risk analysis, saving time when creating and managing the risks. Keeping the Causes in separate entities further permits them to be used as the link between IEC 62304 Software Items and the risk analysis in accordance with the IEC 62304.  

In the PHA, we have expanded the Cause entity to include a “Cause source”-parameter to enable a more precise analysis of risk-causing factors. Correspondingly, the Harm entity has an additional “Has Effect On”-parameter for a more granular designation of the affected agent.

Furthermore, in accordance with best practices from ISO 14971 and other risk norms, the Measure entity contains an additional parameter to explicitly designate risk control approaches such as "Design for inherent safety", "Adding Protective measure", "Providing Information of Safety" etc. This risk control approach can further be connected to the risk reduction parameter controlling the new RPN to ensure that a given risk control approach always results in a consistent risk reduction.

With the Preliminary Hazard Analysis, we have created a capable complement to the existing FMEA risk analysis implementation. We have enlisted the help of renowned industry experts and used input from our client base to build an implementation more aligned with ISO 14971 and industry best practices. The decoupling of the PHA entities in separate Document Object types permits more efficient information reuse than the FMEA implementation. Additional parameters enable the user for a more in-depth analysis of risk drivers.  This has been achieved without compromising the benefits of strict version control, integrated consistency checks, and flexibility that Aligned Elements offers.

If you are interested in a demonstration of the Aligned Elements Preliminary Hazard Analysis, please contact us

Learn more about riskmanagement in Aligned Elements.

Let us show you how riskmanagement works in Aligned Elements during a live demo. 

Zühlke evaluates Aligned Elements

Zühlke Engineering AG in Zürich (http://www.zuehlke.com), is currently evaluating Aligned Elements for use in their product development.  

“We were excited when we found Aligned Elements, since we have a large segment of Medical device projects.", says Claudio Schödler, Project Manager at Zühlke. 

"Currently, we are running a smaller in-house project where all design items are captured in Aligned Elements. All created documents will, later on, be delivered to the end customer. The initial effort has been exceptionally small since the tool is easily configurable and really focuses on everyday tasks.", Mr. Schödler continues. "The evaluation will continue until the summer and will be concluded in an evaluation report.”

We at Aligned are looking forward to the evaluation report and any insights from the skilled Zühlke team!

Aligned Elements V2.1 Service Pack 2

On April 16th, 2014, we release Aligned Elements V2.1 Service Pack 2 (2.1.35.9472).

Aligned Elements V2.1 SP 2 is focusing on bug-fixes and ships with 30+ fixes.

This service pack also includes some minor fixes requested by our users, in particular in the area of risk reporting.

Aligned Elements V2.1 SP 2 can be downloaded here.

Aligned Elements V2.1 Service Pack 1

On January 31st, 2014, we release Aligned Elements V2.1 Service Pack 1 (2.1.28.9239).

Aligned Elements V2.1 SP 1 contains a number of new significant improvements in Aligned Elements Word integration, most notably: 

  1. Optional usage of several Word template sets in a single project 
  2. Optional display of all linked objects in Word Project Explorer 
  3. Forced update of Word documents
  4. Support for MS Word x64 bit installations 
  5. Support for .docm files

This release also includes: 

  • Microsoft TFS Integration
  • Query RPN filter for Objects below and above a certain RPN
  • Query RPN Threshold filter for Document Objects above/below a defined thresholds

Aligned Elements V2.1 SP 1 builds on the improved feature set of AE V2.1 which strengthens Aligned Elements claim to the leading position of Design History File Management solution providers.

Aligned Elements V2.1 released

On August 30th, 2013, we release Aligned Elements V2.1 (2.1.1.8829).

Aligned Elements V2.1 is the new major release from Aligned AG, containing a number of new features for increased control and improved transparency. These include:

  • Breakdown Charts with drill-down capability
  • Consistency Coverage Summary
  • Generation of trace reports to Excel
  • MS Word 2013 compatibility
  • Category Filtering in Project Explorer
  • Integration support for the Countersoft Gemini Issue Tracker

This improved feature set strengthens Aligned Element's claim to the leading position of Design History File Management solution providers.

 

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