Aligned Elements V2.5 Service Pack 3 (2.5.313/114.16963) is here with a great improvement and some important fixes.
What's New
Collaborate using Comments
Use the Comments tab to add comments and send notifications to your team members. Comments can be used to discuss and clarify details or a particular design item during its life cycle. Emails notify comment authors about replies, upvotes, and mentions. Comments are only available in the Aligned Elements web client.
What's Changed
Important fixes regarding risk handling, Word, and merging
Upgrade now
With important improvements and a handful of fixes, this release is a recommended upgrade. Find the installer to Aligned Elements V2.5 SP 3 here.
Written by Karl Larsson on . Posted in Product News.
Aligned Elements V2.5 Service Pack 2 (2.5.307/109.16875) is here and includes several integration improvements and a number of fixes.
Enterprise Architect Integration
Leverage the powerful System Integration models of Enterprise Architect in your Aligned Elements traceability! Enterprise Architect Diagrams can now be part of Aligned Elements item through a live connection with the Enterprise Architect repository enabling both traceability between Design Controls in Aligned Elements and models in Enterprise Architect diagrams as well as the incorporation of EA diagrams in Aligned Elements bi-directional Word reports.
Integration with Redmine
Use Aligned Elements integration with the popular Redmine ticket system to integrate Redmine tickets into your Design Control traceability. Create Redmine tickets from Aligned Elements on the fly when bugs are found during test execution, let Aligned Elements inconsistency checks validate the state of your Redmine items, and use Aligned Elements bi-directional Word Integration to incorporate Redmine ticket into your DHF documents.
Web Client Improvements
We have made a number of usability improvements available in the Aligned Elements Web Client to make your work easier and faster. These include displaying chapter structure in Trace Dialogs, one-click 'Add to Review' action from several views, single-click 'Save document as PDF', 'Find In...' functions to locate Design Control Items in different contexts, Excel exports from tables, and much more.
What's Changed
Integration with Perforce Jobs
Use Test Runs without Configurations
Single-click to find items in Trace / Project Explorer, Files and Test Runs
Compare Word documents using Word's Document Comparison feature
Save Files in their folder structure to disk
Convert files to PDF at save to disk
Do risk reduction in Hazard Analysis and not in Mitigations
Make Unlock Objects a separate user right
Save tables to Excel (Web client)
Revert to Revision (Web client)
Save Trace Table as word template (Web client)
Add to Review from several views (Web client)
Display items in chapter structure in Trace dialog (Web client)
Create Harms and Mitigations on the fly (Web client)
Optional mail invitations sent from Review and Signature (Web client)
Support for table operations in Table attribute (Web Client)
Upgrade now
With important improvements and a handful of fixes, this release is a recommended upgrade. Find the installer to Aligned Elements V2.5 SP 2 here.
Written by Karl Larsson on . Posted in Product News.
Sometimes I get the question "So how much time and money will I save by using Aligned Elements?"
A fair question and a question I can answer with a clean conscience: on average, you will save 30% or more of the time you currently spend on design documentation.
However, some medical device manufacturers can save (and have saved) a lot more than that!
If a modular documentation approach is applied, where reuse of already existing Design Control data is leveraged, there are examples of savings of up to 80%.
In this video below, you can find out more about the possibilities, prerequisites, and benefits received from Modular Design Documentation with Aligned Elements.
Happy Holidays!
Written by Karl Larsson on . Posted in Product News.
It is a well-known tendency that changes made to software (new features, bug fixes, etc.) often lead 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 device 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 guidance 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 ..." enhances predictability and consistency for innovators deciding when to submit new 510(k)s by better describing the regulatory framework, policies, 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 assess 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 therefore suffices.
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.
Written by Karl Larsson on . Posted in Product News.
Aligned Elements V2.5 is here and brings a host of new enhancements 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.
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.
Risk Assessment Improvements
Upon customer request, we have expanded the range of options available for configuring Risk Assessments, including Probability and Severity text dropdowns, an unlimited number of risk zones with customizable coloring, and a fully customizable risk result presentation.
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 of improvements, this release is a recommended upgrade. Find the installer to Aligned Elements V2.5 here.
Written by Karl Larsson on . Posted in Product News.
Reuse. Automation. Two words we really like. You should too since they mean less work for you!
In this spirit, we created the Aligned Elements Automation Tool to speed up your Medical Device documentation work.
Aligned Elements - configured to match the manufacturer's QMS
But first, let's take a step back. As you might know, the way Medical Device Manufacturers compile their development documentation is largely defined in its Quality Management System (QMS). The QMS defines the processes, SOPs and templates used to design and document compliant medical devices in the most efficient manner given the manufacturers' unique situation.
We go to great lengths to adapt and configure Aligned Elements to each customer's QMS. The result is a unique configuration that helps the manufacturer to write consistent, complete, and compliant Design Control Documentation with minimal effort. The configuration defines things like:
Consistent naming of all Design Controls
Customizable Quality Control checks
Flexible Risk Assessment parametrization
The Expected Traceability and rules to detect deviations
Customer-specific Report Designs
Each time a new Aligned Elements project is created, the configuration makes sure that the created content is structured and aligned with the manufacturer's QMS.
Reusing existing content
However, when documenting a device, it often turns out that much of the created content itself has the potential to be reused in other projects. Moreover, if established content is used uniformly across all device projects, a higher degree of consistency is established. Such content can include:
Standard Design Control Items
Chapter structures
Trace Tables definitions
Frequently used Queries
Dashboard setups
Chart settings
Project settings like E-signature preferences and Email SMTP settings
Users and User Groups
Automated Reuse
These things have always been reusable in Aligned Elements With the Aligned Elements Automation Tool, it is now possible to transfer these settings to new and existing projects with a single click.
Setting up a new Aligned Elements project containing your company's established best practices is done within seconds! The Automation Tool is the best way to swiftly leverage existing content in a consistent manner and shorten the project setup time to an absolute minimum.
So how does it work?
The Automation Tool combines a number of action steps in a single xml file and executes these actions against a selected set of projects.
Multiple actions against multiple projects are performed in a single session.
The Automation Tool is installed as a Windows Application for manual use, as well as a Console application that can be used and triggered from other programs.
Note! The Aligned Elements Automation Tool leverages the Aligned Elements REST API. Deploying the Aligned Elements Web Application is thus a prerequisite to use the tool.
The Aligned Elements Automation Tool can be downloaded here.
Written by Karl Larsson on . Posted in Product News.
This service pack contains an assortment of small to medium improvements. As always, it is based on a significant amount of input from the Aligned Elements User Community. The strongest focus is on improvements in user management, web usability, and Word reporting.
Improved User Handling
Collaboration with development partners in Aligned Elements is definitely something that will speed up your documentation work. But sometimes, some functions and data should stay off-limits for your partners. With improved access management, Aligned Elements restricts access to functions and data and ensures that information is shared on a need-to-know basis. Optional log-in with Microsoft credentials is also possible, as well as optional display of full name and/or email of users wherever user actions are displayed.
Inline Editing in Tables
The Aligned Elements Web client now supports inline editing in Design Control Items tables. This greatly improves usability as the Items don't have to be accessed individually for editing. A set of Items is opened for editing in table mode with a single click. Select the attributes to be displayed in the table, edit as you like, and save all items with a single click.
Word Improvements
Aligned Elements now optionally keeps track of Design Control Items inserted as Queries, Risk Tables, and Trace Tables and will highlight any outdated documents where the items have changed after they were placed in the document. More flexibility in handling Word Template variants and enhanced coloring of Risk Assessments are welcome contributions from our users.
What's Changed
Automatically add new Items to active Tags
Test Runs - Automatic removal of old attachments and issues at re-execution
Test Runs - Assign failed tests to new Test Run
Project Search Bar in Open Project Dialog
Generate, copy or execute multiple items in a single action
Signature stamp improvements now include time and time zone information
Set Traces to existing items in Table Attributes
Import / Export of Project Settings
Synchronized import without synchmap files
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 6 here.
Written by Karl Larsson on . Posted in Product News.
Aligned Elements V2.4 SP 5 (2.4.213.14327) is a hotfix for solving an upgrade problem for projects from V2.4 SP 2 and earlier to the newest version of Aligned Elements.
Upgrade now
This is the recommended version.
Find the installer to Aligned Elements V2.4 SP 5 here.
Written by Karl Larsson on . Posted in Product News.
With a complete overhaul of the Aligned Elements Web Client frontend, we are pleased to give you a much better user experience. In this release, we also introduce the Aligned Element dashboards, improvements to the Review Experience as well as several changes requested by our customers (to whom we always listen!)
Dashboards
Have you ever thought that although there is an immense amount of valuable information in Aligned Elements, getting an overview of the current state of affairs is not particularly straightforward? Enter Dashboards, you can now configure your own cockpit from a large number of Widget types. Web client information at your fingertips!
Web Client Frontend UX Enhancements
With proper Sidebar navigation as well as side-by-side operations of Project/Trace Explorer and the Items, the need for jumping back and forth is significantly reduced. Event-based updates remove the need to manually refresh. A useful Test Run Burndown chart now tracks your progress.
Enhance Design Review UX
The Design Reviews now display the Design Control Items just like they appear in your documents. You can create and assign issues directly to the Design Control Items without having to leave the context. We have also added an option for the Reviewer to explicitly state completion of all assigned tasks with a single button click.
What's Changed
New Inconsistency rules for Missing Test Executions in Test Runs and Unique attribute values
Improvements in the management of External Issue Management systems
Clearing File attribute values
Warn on commit on selected inconsistencies
Improved performance for Cloud Projects
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 4 here.
Written by Karl Larsson on . Posted in Product News.
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.
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 resolutely 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 checklist here:
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 checklist and is 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 users in order to help them accelerate their medical device Design Control documentation effort. Browse through the available extensions and discover how they could accelerate your project.
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.
Web Client Usability
Improved linked project support, as well as the display of Help Texts, have been implemented in this release.
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.
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.
Written by Karl Larsson on . Posted in Product News.
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.
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.
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.
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.
Written by Karl Larsson on . Posted in Product News.
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.
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!
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.
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:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Written by Karl Larsson on . Posted in Product News.
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.
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
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.
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.
Improved Signing Experience
List your pending signature tasks with a single click. Electronically sign single or multiple documents with a simple point and click.
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.
Written by Karl Larsson on . Posted in Product News.
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.
Written by Karl Larsson on . Posted in Product News.
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.
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!
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.
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.
Written by Karl Larsson on . Posted in Product News.
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.
Written by Karl Larsson on . Posted in Product News.
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.
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.
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.
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
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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.
Written by Karl Larsson on . Posted in Product News.
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.
Written by Karl Larsson on . Posted in Product News.
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.
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.
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.
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.
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.
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.
Written by Anders Emmerich on . Posted in Product News.
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.”