Risk Management
so easy
you will love it

Get iRISK™: Risk Management

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Never lose sight of what matters

Keep full visualisation of your risk status with your dashboard. Manage projects, visualize risks, monitor control strategies and ensure user productivity.

Perfectly customisable, with different layers of information according to user roles.

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iRISK dashboard
iRISK dashboard

The Quality Risk Management of your entire organisation.
In one platform.

Easily map out your quality attributes, process parameters and operations for all stages of the product lifecycle, in all your sites.

And then, evaluate and design robust control strategies, aligned with QbD practices, aimed at promoting product consistency and compliance.

Assess your risks the way you need to assess them

iRISK™ connects all the tools you need. Tools designed to identify, quantify, evaluate and mitigate risks and generate knowledge, in an integrated and holistic fashion.

You will be able to choose from 50+ tools to build your workflow and cover your entire risk management process. This means being able to account for your production and post-production activities and maintain all your risks under control.

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iRISK dashboard
iRISK dashboard

See the full picture. Always.

Take full advantage of iRISK™'s embedded visual capabilities. Analyse auto-generated graphics and maps, and create your own specific graphical queries.

With it, you can use iRISK™'s automatic comparison module to compare multiple assessments and optimise decision-making for tech tranfers, scale-up processes, post-approval changes and more!

iRISK™: Risk Management means better performance



of time saved performing Risk Assessments



less time needed to create an FMEA for each unit operation

sheet with checkmark

3 times

faster documentation system

growing graph

5-10 times

productivity improvement for report creation



of acceleration when you implement post-approval changes

laptop and two gears


of effort spared from managing all the risks in the company by using an automated and centralised platform

Implementing iRISK™

We understand that you need to have a clear picture of when would iRISK™ start making your Risk Management so much easier. Our deployment process is very streamlined, which is why we can predict that a standard installation will take approximately one month.

You should keep in mind that, if a customised iRISK™ better fits your needs, these installation timelines will be adjusted and agreed with you based on the extent of the required customisations.

iRISK implementation: one month


computer screen

Our team will make sure the system works properly and that your other systems are perfectly integrated iRISK™.


At this point, we will deliver a carefully planned training to your team to make sure you can make the most out of iRISK™.

person on top of a mountain

It's Go-Live time! This also marks the start of the one month Hypercare phase where we will support closely your iRISK™ use.

Annual User License model

iRISK™ is licensed through an annual subscription for each user. User License price decreases as the total of purchased User Licenses increases.

Support & Maintenance

iRISK™ includes upgrades and fixes, as well at least 5h per year, per User License of Remote Support.

Deployment Strategy

iRISK™ can be deployed at a client's infrastructure/cloud or using 4TE cloud provider (Microsoft Azure).


iRISK™ is your platform. This means that it will be adapted to your organisation's unique requirements so that you can maximize the potential of your team's performance.


The expertise of our team when dealing with most data sources means that iRISK™ can be integrated with virtually any 3rd party software.

Data safe

We will load all your historical data and templates into iRISK™. This means that you will get only benefits from adopting a new tool and none of the friction.

iRISK™ Stories

GSK logo

“We work with 4TE to digitalise our QbD framework within GSK for the development of our new Vaccines, applying iRISK™ solution. 4TE team customized iRISK™ to adapt its solution to our QbD approach; 4TE works in an agile way, being always responsive, proposing the best user friendly solutions.

We are confident that this customized version of iRISK™ for our Vaccines development through Quality by Design will be key for simplification, acceleration and knowledge management.“

Corden Pharma logo

"When we decided to go with iRISK from 4TE, we warned them that this would be a challenge for them as we wanted to have the roll-out concluded within less than 6 months. But the support we received from all of their team members, their willingness to accommodate our requests and timelines, and their expertise in resolving all the issues that came up during the project was amazing."

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