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System Requirements
System Requirements
Web Client
Recommended Requirements
| Browser | Currently stable release of Edge, Edge Chromium, Google Chrome, Firefox or Safari |
| MS Word | Standalone Word 2019 or later (32-bit or 64-bit) or Word 2013 or later with Office 365 |
Windows Server Requirements
Recommended Requirements
| Processor | 2 cores |
| RAM | 8 GB |
| Hard Drive | 250 GB |
| Operating System | Windows Server 2012 or higher |
| Database Server | Aligned Elements uses Microsoft SQL Server for persistence. |
| SQL Editions | SQL Server Enterprise, SQL Server Standard, SQL Server Web and SQL Server Express with Advanced Services are supported. |
| SQL Versions | SQL Server versions 2005, 2008, 2012, 2014, 2016, 2017, 2019 and 2022 are supported. |
Web Application Server Requirements
Recommended Requirements
| Web Server | Aligned Elements uses Microsoft IIS Web Server. |
| Version | IIS 8 or higher |
Windows Client
Recommended Requirements
| RAM | 4 GB |
| Hard Drive | 2 GB Free Space |
| Operating System | Windows 7, Windows 8, Windows 10, Windows 11 |
| MS Word | Word 2013 or later (32-bit or 64-bit) |
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Genuine Voices, Tangible Results
Genuine Voices, Tangible Results
Try free Trial
Get Started With a Free Trial Today!
Try our world-class eQMS and Design Control Management and see how hundreds of Medical Device companies accelerate their journey with Aligned.
What you get for free:
- 30 days free trial
- Access to the Aligned eQMS
- Access to the Aligned Elements ALM
- Medical Device example projects included
- Free technical support
No Credit Card needed!
If you need a trial extension, just let us know.
Need to know more?
If you want assistance to try your own QMS and/or development process in Aligned Elements, we'd be happy to assist you and work out a trial configuration for you.
Seeing your existing development documentation data in Aligned Elements can make it easier for you to assess how the system could assist your organization. We can help you parse and import your existing documentation into a test project.
How do the Aligned Elements Licensing plans work?
Still have questions about Aligned Elements?
Feel free to contact us if you have any questions.
Pricing
Pricing Plans
Start a free 30-days trial today!
Find out more about our package offerings below!
Aligned Elements
Design Control ALM
650€
per month
Incl. 2 Floating Licenses
billed yearly
- Full Design Control Mgmt
- ISO 14971 Risk Management
- End-to-End Traceability
- Auto-Consistency Checks
Aligned eQMS
Popular
Starter Package
1000€
per month
Incl. 3 Floating Licenses
billed yearly
- All Aligned Elements Features
- 14 SOP:s and 55 Templates
- Document & E-Signature Support
- Training Management
- Supplier Managemenet
Aligned eQMS
Full Package
2085€
per month
Incl. 5 Floating Licenses
billed yearly
- All Aligned Elements Features
- 31 SOP:s and 100+ Templates
- Quality Event Management
- Audit Management
- Equipment Managemenet
Aligned Elements
Design Control ALM
400€
per month
Incl. 2 Floating Licenses
billed yearly
- Full Design Control Mgmt
- ISO 14971 Risk Management
- End-to-End Traceability
- Auto-Consistency Checks
Aligned eQMS
Popular
Starter Package
850€
per month
Incl. 3 Floating Licenses
billed yearly
- All Aligned Elements Features
- 14 SOP:s and 55 Templates
- Document & E-Signature Support
- Training Management
- Supplier Managemenet
Aligned eQMS
Full Package
1830€
per month
Incl. 5 Floating Licenses
billed yearly
- All Aligned Elements Features
- 31 SOP:s and 100+ Templates
- Quality Event Management
- Audit Management
- Equipment Managemenet
Compare Plans
| Aligned Elements | eQMS Starter | eQMS Full |
|---|
- Design Control Management
Flexible Requirement Management ISO 14971 Risk Management AI-Driven Verification Management Design Validation Management End-to-End Traceability Automated Consistency Checks Integrated Design Reviews Use Scenario & Task Management Powerfull Tech Doc Reporting Integrated DHF Index E-Signatures 2000 EUR
- QMS Content
Included SOP:s - SOP101 Human Resources
SOP200 Design and Development
SOP204 Software Development
SOP208 Cybersecurity Management
SOP209 Released Software Management
SOP300 Documents and Records
SOP301 Performance Evaluation
SOP302 Change Management
SOP303 Infrastructure
SOP304 Supplier Handling
SOP305 Risk Management
SOP306 Usability Engineering
SOP307 Labeling
SOP308 Validation of Computer Software
_____
10 000 EURAll SOP:s in Starter Pack
SOP100 Management
SOP102 Audits
SOP103 PMS
SOP104 Complaints and Vigilance
SOP105 Corrective and Preventive Action
SOP106 Nonconforming Product
SOP201 Purchasing
SOP202 Production
SOP203 Sales
SOP205 Incoming Inspection
SOP206 Storage Packaging Delivery
SOP207 Technical Service
SOP301 Clinical Evaluation
SOP309 Statistically Valid Sampling
SOP310 Process Validation
SOP311 Equipment Control
SOP312 Device Cleanliness Sterilization Contamination Control
_____
20 000 EUR
- Document Control Management
Centralized and Secure Repository - Version Control - Audit Trail - Automated Workflows -
- Training Management
Automated Action Assignment - Training/Document Linking - Training Progress Tracking -
- Change Management
Change Request Management - Change Request Planning - Change Request Reporting -
- Supplier Management
Supplier Selection & Approval - Supplier Handling - Supplier Re-Evaluations -
- Computer System Validation Management
Software Tool Library - Risk-Based Validation Assessment - GMP & FDA 21 CFR Part 11 Assessment - Validation Planning - Validation Reporting - Periodic Re-evaluation -
- Quality Event Management
Feedback & Complaints Management - - Nonconforming Products - - Nonconformity Assessments - - CAPA Management - - Vigilance Reporting Management - -
- Audit Management
Audit Program Management - - Audit Planning - - Audit Reporting - -
- Equipment Management
Equipment Management - - Equipment Control - -
Additional Packages
Getting up and running fast is important for most of our customers. To provide best possible fit between Aligned Elements and your existing organization, we offer the following add-ons:
| Configuration Support | 3500 € | Aligning with your Development ProcessWe configure Aligned Elements according to your quality management system for seamless integration with your existing Development processes and templates. |
| On-Site User Training | 2500 € | On-site User TrainingFull-day training of up to 12 of your employees on your company site. The training warrents a certificate of completion if the final test is passed. |
| Online User Training | 1200 € | Online User TrainingFour two-hour online sessions for 12 users. The training warrants a certificate of completion if the final test is passed. |
| Integration with External System | 2000 € | Integration with External SystemIntegrate Aligned Elements with Jira, TFS, Enterprise Architect, GitHub and many other system to get the most out of your existing infrastructure. |
| Integration with Automated SW Tests | 2000 € | Integration with Automated SW VerificationLeverage existing automated software tests in your traceability. Integrate Aligned Elements into your continuous build chain and automatically export results from your automated software tests into Aligned Elements. |
| Consulting Services | Deployment, Quick Start and Validation ServicesIf you need further help, we assist you with tasks such as:
|
Request a quote today!
Ask us for a tailored pricing quote!
Other Aligned Elements Versions
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Contact us
Aligned AG
Klingenstrasse 37
8005 Zürich
Switzerland
Office hours
09:00 - 18:00 CET
Phone
Main Office
Sales Information
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Aligned AG
We are Aligned. Our purpose is to assist our customers to develop innovative Medical Device in less time, using less resources.
Aligned was founded in 2006 by a team of experienced medical device developers with extensive and international background in the Life Science Industry.
Our clients are manufacturers, end-customers and sub-suppliers in the medical device industry, companies who develop and market products which are subjects to regulatory compliance such as FDA Quality Systems Regulations or the EU MDD/MDR and IVDD/IVDR.
Our goal is to enhance our customer's capabilities in how to rapidly and successfully create quality compliant medical devices through excellence in regulatory documentation.
Our Story
"There must be an easier way to document than this!"
We loved developing medical devices!
Not only was it exciting (it still is!), innovative and creative. It also felt meaningful; doing something that could benefit the health of potentially thousands of patients and users.
But then there was the documentation... It was always there – with us putting in endless hours on completing it, piling up as a vast mountain of binders. It sometimes felt like we were spending more time documenting than innovating. All we wanted to do was to develop devices and here we were, conducting frustrating, menial, repetitive documentation tasks.
We had fantastic, state-of-the-art engineering tools at our disposal, but for documentation we were stuck with Word and Excel. The resulting work was as you could expect. Auditors kept finding inconsistencies, errors and gaps and no matter how many times we reviewed our own documents, errors kept slipping through. Our confidence in our own documentation work was ailing at best.
We were convinced that there must be a better way to handle the documentation work than the way we were doing it. We were also convinced that medical device companies all over the world probably felt just the same way as we did.
In 2006, we started to work on Aligned Elements with the explicit goal to build a solution that could reduce the amount of work spent on development documentation while, at the same time, make sure that the resulting documentation was as error-free as possible.
Today, many years later, Aligned Elements has grown and expanded with the input from our customers, helping us to find smarter and better ways to reduce the documentation effort. We keep a close eye on regulatory changes and the challenges they entail and always, always ask ourselves, “how we can help our customers to become compliant with the least possible effort?”
At Aligned, we have our roots knee-deep in the everyday-life of medical device development and the documentation challenges that come with it.
Like you, we want medical device development to be about innovation. Afterall, that is where your hard-earned expertise lies, where you can bring most value and, quite frankly, what you were hired to do!
What we do
Aligned provides Aligned Elements, an ALM system to ensure compliant development documentation for regulated products in the Medical Device Industry.
We assist our clients in developing, manufacture and market regulatory compliant products within shorter time-frames, to lower costs and with higher confidence.
At Aligned, we believe that management of product and project documentation of regulatory compliant products shall be efficient and pragmatic. We advocate an approach that allows your development team to focus on innovation instead of administration.
We strive to build value that last and therefore stay deeply involved with the undertakings of our clients until we are sure that sustainable results are achieved.
Request Trial Extension
If you did not get a chance to fully try out Aligned Elements or need a little more trial time to evaluate the product, simply enter your email address and click Submit to re-activate your Aligned Elements user.
You will be sent a confirmation email as soon as your user has been re-activated.
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Privacy Policy
Key Details
This privacy policy describes how Aligned AG protects and makes use of the information you give the company when you use this website.
If you are asked to provide information when using this website, it will only be used in the ways described in this privacy policy.
This policy is updated from time to time. The latest version is published on this page.
The website privacy policy was last updated on 2024-05-23
If you have any questions about this policy, please email
Privacy Policy
Aligned AG
Klingenstrasse 37
CH-8005 Zürich
Switzerland
Tel: +41 (0)44 312 50 20
Introduction
Aligned AG operates www.aligned.ch. We gather information about individuals in order to provide these individuals with information about our products and services.
We also collect information to better understand how visitors use this website and to present timely and relevant information to them.
What data we gather
We collect contact information from visitors, in the following situations, when they explicitly:
Request access to a demo version of Aligned Elements
Collected personal data: Name, Email, Company, (optional) telephone number
Request a quote from Aligned Elements
Collected personal data: Name, Email, Company, telephone number
Subscribes to our Blog/Newsletter updates
Collected personal data: Name, Email
Provides information about a bug or change request in Aligned Elements
Collected personal data: Name, Email
Register to one of our seminars
Collected personal data: Name, Email, Country, Company, Job title
Browsing Information
We use Hotjar in order to better understand our users’ needs and to optimize this service and experience. Hotjar is a technology service that helps us better understand our users’ experience (e.g. how much time they spend on which pages, which links they choose to click, what users do and don’t like, etc.) and this enables us to build and maintain a relevant website. Hotjar stores this information on our behalf in a pseudonymized user profile. Hotjar is contractually forbidden to sell any of the data collected on our behalf.
How we use the data
We use the collected contact information to provide the visitor with the information he/she has requested.
We also use the contact information to inform, upon their own request, visitors about product and service updates and upcoming seminars.
Cookies and how we use them
What is a cookie?
A cookie is a small file placed on your computer's hard drive. It enables our website to identify your computer as you view different pages on our website. Cookies allow websites and applications to store your preferences in order to present content, options, or functions that are specific to you. They also enable us to see information like how many people use a website and what pages they tend to view.
How we use cookies
We use cookies to analyse our web traffic using Google Analytics, Google Ads Conversion Tracking and Google Tag Manager. You will find more information concerning the treatment of user data by these Google tools in Google's Privacy Policy.
Cookies do not provide us with access to your computer or any information about you.
Our site has embedded YouTube videos. When you visit a page with an embedded YouTube video, a connection to YouTube servers is established. This tells Youtube which pages you are visiting. If you are logged into your Youtube account, Youtube can assign your web usage behavior to you personally. You can prevent this by logging out of your Youtube account beforehand.
Our site uses the "LinkedIn Share Button". When you click on such a button, a connection is briefly established via the user's browser to servers of LinkedIn, with which the functions of the button, including the display of the count value, are performed. LinkedIn does not store any personal data of the user about the visit to the page, in particular no IP address is stored.
Our site uses Hotjar which uses cookies and other technologies to collect data on our users’ behavior and their devices. This includes a device's:
- IP address (processed during your session and stored in a de-identified form)
- device screen size
- device type (unique device identifiers)
- browser information
- geographic location (country only),
- the preferred language used to display our website.
Controlling cookies
The web site will let you choose to what extent cookies from our web site are stored on your computer. Use these settings as you see fit.
Further, you may prevent the collection of data generated by cookies (including your IP address) and related to the use of these websites, as well as the processing of such data by Google, by downloading and installing the plug-in under the following link: http://tools.google.com/dlpage/gaoptout?hl=en
To learn more about cookies and how they are used, visit All about cookies.
Controlling information about you
If you have agreed that we can use your information for the purposes stated in the forms you fill in, you can always change your mind at a later stage.
What are your privacy rights, and how can you exercise them?
You have the right to:
- access your personal data and to be provided with certain information in relation to it, such as the purpose for which it is processed, the persons to whom it is disclosed and the period for which it will be stored
- require us to correct any inaccuracies in your personal data without undue delay
- require us to erase your personal data
- require us to restrict processing of your personal data
- receive the personal data which you have provided to us, in a machine readable format
Please note that these rights are not absolute and are subject to certain exemptions under applicable data protection law.
If you want to opt-out from the agreement or want us to delete your data, please notify us by emailing
Privacy Policy
Aligned AG
Klingenstrasse 37
CH-8005 Zürich
Switzerland
Who do we share your personal data with?
In some cases, we store your data for further processing. Depending on the purpose, we store them in our own secure systems (to handle demo requests, quote requests, bug requests or contact information), in Linkedin (to handle Event registration), in Hubspot and Sendgrid (to handle Newsletter subscriptions) or Hotjar for website analysis.
We will never lease, distribute or sell your personal information to third parties unless we are required to by law.
We may disclose personal data to public authorities, regulators or governmental bodies when required by law or regulation or if an authority or governmental body has issued an order requesting such personal data from us. Before we provide the information, we will inform you if the applicable law allows us to do so.
How long do we keep your personal data?
We only store personal data for as long as it is necessary to fulfil the purpose for which it was collected or to comply with legal or official requirements.
Security
No other users will see the information you have entered. To prevent unauthorized disclosure or access to your information, we have implemented strong physical and electronic safeguards. However, we may store Personal Information in locations outside our direct control (for instance, on servers or databases co-located with hosting providers).
Although we use Security Sockets Layer (SSL) encryption technology to encrypt sensitive personal information before it travels over the internet, remember that no method of transmission over the internet, or method of electronic storage is 100% secure. While we strive to use commercially acceptable means to protect your personal information, we cannot guarantee its absolute security.
Compromise of Personal Information
We will promptly notify those persons whose Personal Information is compromised. Notwithstanding, Aligned AG does not accept liability for any unintentional disclosure or a disclosure that occurs due to a security breach of our systems or facilities.
Data Protection Officer
Karl Larsson
Aligned AG
Klingenstrasse 37
CH-8005 Zürich
Switzerland
Tel: +41 (0)44 312 50 20