i R I S K


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4Tune Engineering develops intelligent engineering solutions. Focused on operational excellence, we assist companies improve decisively the entire lifecycle of their products and processes. Founded in 2004 and with offices in Lisbon and São Paulo.

Increase team productivity
with this powerful
Risk Management

Leading digitalization onPharma and Biopharmaindustries

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One Platform. All the tools you need.
iRISKTM has everything you need for Risk Management over lifecycle.


iRISKTM applies the best principles and tools to ensure that your risk activities are aligned with the increased regulatory demands of FDA, PIC/S, GMP-Annex 15, EMA and ICH guidelines.


Compare different production lines, equipment, suppliers and scenarios for optimal risk-based decisions using iRISKTM.


iRISKTM is a Knowledge Management enabler prepared with knowledge harvesting tools, allowing you to use a search-engine and benchmark your risk analysis activities with other users. iRISKTM simplifies and speeds the beginning of new risk assessments saving time and money.


Whether your team is across the table or around the world, iRISKTM brings a new level of transparency to your team’s work and keeps everyone on the same page bringing consistency to your organization risk analysis.

Increase the Agility of your work

See how easy it is to compare results across your company with iRISKTM.
Build your mitigation strategies with a risk-based approach.

Make your own Workflows

Every team has a unique strategy to work on their projects. Use one of our QbD workflows or create one to match your standards.

Personalized Dashboard

Be able to customize your dashboard and monitor the important metrics in a single screen.


iRISKTM is a collaborative platform that works across different production sites, business units and user levels, allowing consistent risk analysis across the organization.

Information updated in real time for everyone
Assign roles & responsibilities
Unlimited number of users


It’s time to leave the spreadsheets behind. We provide a seamless transition to migrate your templates into our solution.

Easily track document versions
Consistent risk analysis across the organization
Comparison of risk profiles over lifecycle


Easily navigate within iRISKTM and start your Risk Management journey with a clean and user friendly platform.

QRM implementation has never been so easy
Build your workflow in minutes
All key tools interconnected

Data integrity

With iRISKTM maintain data integrity and assure that every change is registered throughout its entire lifecycle.

Backup Data

Access Control

Audit Trail

iRISKTM Features

Navigate through the iRISKTM world - you will find everything you need to make your Quality Risk Management easy, robust and consistent.

Implemented with success in companies around the world

Sneakpeak of what you can find in iRISKTM

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