The Next Generation Risk Management Platform.

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Become future-ready for a new regulatory landscape.

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iRISKTM

All necessary tools integrated in one platform for risk management throughout the lifecycle.

Editions

Leave your spreadsheets behind

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

Connect to 3rd party systems

Our expertise dealing with most data sources enables us to provide various 3rd party software integrations.

Ready for global companies

iRISK is a collaborative platform that works across different production sites, business units and user-levels. It is a Knowledge Management enabler by allowing users to use a search-engine and benchmark their Risk Analysis activities with other users.

Go beyond Risk Assessments

With iRISK proprietary features compare different production lines, equipment and scenarios for optimal risk-based decisions.

Product Description

iRISK is a risk-management platform to identify, quantify and prioritize risks and to formulate risk mitigation strategies over lifecycle (control strategy) for new or existing processes. It is built to ensure that your risk activities drive your Business Processes and are aligned with FDA, EMA GMP-Annex 15 and ICH guidelines.

"Having all tools connected is extremely valuable for us, as well as the ability to monitor risks for different products and prioritize actions.”

Director, Large Biopharma (USA), 2016

Get in Touch with Us

Our offices are in Portugal, Germany and Brazil.

iRISK Sales&Support
Av. António Augusto Aguiar, 108 - 5
1050-019 Lisboa, Portugal
Phone: +351 21 606 2788
Email: irisk@4tuneengineering.com
4Tune Engineering Ltd
Av. António Augusto Aguiar, 108 - 5
1050-019 Lisboa, Portugal
Phone: +351 21 606 2788
Email: info@4TuneEngineering.com
4Tune Engineering GmbH
Munich, Germany
Phone: +49 8912 140 56 84
Email: info@4TuneEngineering.com
4Tune Engenharia Brasil
Avenida Narciso Yague Guimarães
1145 - Sala 1008 - Helbor Concept Office
Mogi das Cruzes - São Paulo, Brasil
Phone: +55 11 4118 6207
Email: info@4TuneEngineering.com