The Next Generation Risk Management Platform.

Request Demo

Become future-ready for a new regulatory landscape.

Request Demo

iRISKTM

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

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 and Brazil.

iRISK Sales&Support
Av. António Augusto Aguiar, 108 - 4
1050-019 Lisboa, Portugal
Phone: +351 21 606 2788
Email: irisk@4tuneengineering.com
4Tune Engineering Ltd
Av. António Augusto Aguiar, 108 - 4
1050-019 Lisboa, Portugal
Phone: +351 21 606 2788
Email: info@4TuneEngineering.com
4Tune Engenharia Brasil
Avenida Vereador Narciso Yague Guimarães, 1145
Sala 1008 (Helbor Concept Office)
Phone: +55 11 4118 6207
Email: info@4TuneEngineering.com