With a solid QMS, we configure, train, and implement Aligned Elements in 2 weeks for your first product.

Our record: Customer productive 12 days after contract signing.

We offer a 3-4 day package for custom configuration to reflect your QMS.

Typical user adoption: We help you setup according to your QMS since we understand normal medical device workflows, deliver the user training and your team will be ready to go for productive use.

Aligned Elements is built for QMS evolution.

When you adjust processes, we configure the software accordingly without extra costs. The QMS development phase is ideal for start working with Aligned Elements because you start immediately with systematic traceability instead of migrating legacy chaos later. Moreover, developing your QMS in conjunction with configuring Aligned Elements will allow you to allow process and system in a natural manner.

Every month with fragmented documentation costs money in wasted engineering time. Add an existing compliance risk to that.

Our 2-week POC requires 4-8 hours of your time is enough for you to gather insights on how much money you can save.

Many customers start POCs parallel to daily business with smaller products.

Can you afford 6 more months with 25-45% engineering overhead for documentation?

Aligned Elements is explicitly process independent, meaning that your processes can stay just as they are.

Your current Word templates can (most probably) be applied in Aligned Elements' integrated Word reporting mechanism, meaning that the look and feel of your Word templates will stay intact.

• Floating (sometimes also called "concurrent") licenses
• Node Locked (sometimes also called "named" or "personal") licenses
• Review Licenses

The number of licenses you need depends on how your team will use the system and whether you choose dedicated user (named) licenses or concurrent (floating ) licenses.

Dedicated user (named) licenses are assigned to a specific person. This is an excellent choice for heavy users that uses the system often as a core part of their role.

Floating (concurrent) licenses can be shared among multiple users. The license is only used while someone is actively logged in. This means the number of licenses you need depends on how many people are expected to use the system at the same time. For example, if 20 people may use the system but usually no more than 5 are logged in simultaneously, 5 floating licenses may be sufficient. This license type is optimal for that uses the Aligned products as supporting tools, using them occasionally or during certain times and is therefore also more cost efficient.

A common approach is to estimate the maximum number of simultaneous users.

If most users access the system occasionally, floating licenses can reduce the total number required.

If users need guaranteed access at any time, dedicated licenses are usually the better choice.

If you are unsure, we recommend starting by estimating:

• The total number of people who need access
• The maximum number of users who will be logged in at the same time
• Whether certain users require guaranteed access

Based on this information, you can determine the most suitable combination of dedicated and floating licenses for your organization.

Any number of additional licenses can be bought at any time. For administration convenience, we usually suggest that the expiration date for the additional licenses is matched to the expiration date of the initially purchased licenses.

With many options on both package size, licensing and deployment, we are sure we can find the right fit for you.

Have you looked into the floating license model for efficient license sharing?

Have you considered our on-premise deployment option, levereging your existing IT infrastructure? 

Or maybe our Starter eQMS package is the right choice for you?

Why not start with a POC: Invest €2-5K for 4 weeks hands-on experience with real data?

If the POC doesn't meet expectations, you have clarity for little investment instead of €200K for a tool that doesn't work. If you move forward with buying an Aligned product, we even deduct the cost of the POC.  

Post-purchase journey:

1) Immediatly: We start setting up your infrastructure.

2) Kickoff within 48h with technical onboarding plan.  

3) Week 1-2: Software configuration and adaptation per your input/QMS. 

4) Week 3-4: Team training on your new system. Finetuning per input during the training. Close collaboration and hands-on support during first usage.

5) Month 2-3: Phased rollout to additional products.

Support: Direct access to founder team for technical escalations, typical response under 24h.

Validation is per definition the activity to ensure that a system works according to its intended use in an organisational context.

Since both the Aligned eQMS and Aligned Elements is a highly configurable system, built to adapt to your individual company needs, your Aligned system needs to be validated based on the adaptations you do.

For these reasons, the Aligned products are not delivered in a validated state.

To assist you with the validation we do provide you with:

• a validation package containing an example validation
• a pre-filled FDA QSR 21 CFR Part 11 assessment
• access to our internal development and verification documents

We can also assist you with performing the actual validation activities.

There are several ways to insert data into Aligned Elements.

• The primary way is to use the Document Object forms for manual data entry.
• DHF data can also be imported from Word, Excel (via csv), Req-IF and xml (by applying an appropriate XSLT conversion).
• You can also generate data from our regulatory wizards, downloaded and imported from our preconfigured packages on our website.
• You can of yourse also copy and import data from other existing Aligned Elements projects.

We always support our new customers with data migration / transfer.

If you have questions, please contact our This email address is being protected from spambots. You need JavaScript enabled to view it..

There are three major deployment options available:

Aligned eQMS and Aligned Elements as Hosted Application (Saas)

We (Aligned) provide your Aligned Products as Saas. We take care of all deployment, security, updates, maintenance and backup activities.

You will have a dedicated set of resources, not shared with any other of our customers.

You get to choose the geographical location of where your Saas infrastructure is located. 

In order to not upset your validated state, we never deploy Aligned updates without your explicit permission.

Aligned Elements deployed in your Cloud Resources

If you already have available cloud resources, we can deploy Aligned Elements there. 

We assist you with documentation, videos and support through out the deployment process.

The System Requirements are available here.

Aligned Elements deployed On-Premise

If you already have IT infrastructure in place thath you would like to leverage, e.g. for cost and security reasons, Aligned Elements is available for On-Premise deployment.

We assist you with documentation, videos and support through out the deployment process.

The primary way of exporting data is to use the Word integration. This mechanism automatically generates Word documents from your DHF data while applying your company Word templates keeping your current look-and-feel intact. Aligned Elements also support a powerful xml/xslt driven export function that outputs all DHF including rich content, traces, etc. You will never be locked-in using Aligned Elements.

The minimum term of service for the initial purchase is 12 months.

Single sign-on (SSO) with Microsoft Entra can be set up both for the Aligned eQMS and Aligned Elements. 

We are not big fans of vendor lock-ins. Therefore the Aligned products are equipped with several ways to export your data.

You can batch download your existing documents in their original formats.

You can also batch export all record/design control data into xml, which includes meta information such as change logs, traceability information, tag data etc.

Furthermore, you always have access to your Aligned unique configuration which defines and explains how your quality data has been captured and structured.

Thus, your data is your data, available to you whenever you need it.