4Tune Engineering
Powering Digital Transformation in the Pharma Industry

Founded in 2004, 4Tune Engineering has been developing intelligent solutions for the pharma industry to achieve operational excellence by optimising the entire lifecycle of their products and processes. The company’s Quality Risk Management platform iRISK^TM supports the digital transformation of pharmaceutical organisations and helps implement a paperless culture. iRISK^TM helps proactively identify and control potential quality issues during the drug development process, p.e., by de-risking the entire product lifecycle. “With a holistic view of the entire product lifecycle, we can help identify hazards associated with pharmaceutical products to focus on safety of drugs during development and minimise the risk of harm to patients,” says Marcos S. Domingues, CEO of 4Tune Engineering. Similarly, the company enables clients to speed up the drug development process and reduce the time-to-market.

4Tune Engineering’s iRISK^TM combines all the necessary risk management tools integrated into one platform. The iRISK^TM platform is an integrated solution adaptable to every Quality Risk Management (QRM) need in a collaborative cloud-based-platform suited for Industry 4.0. Here, clients can have a standardised QRM and give their inputs directly through the platform following a QbD (Quality by Design) approach. Similar to iRISK^TM, the company offers iRISK4CQV^TM, with an integrated Commissioning, Qualification & Validation (CQV) workflow specific to pharma operations, also following a QbD approach.

Moreover, for risk management, 4Tune Engineering’s Risk Register platform is an integrated and simpler solution, which allows for a streamlined environment where strategic risks are filled, managed and analysed, while ensuring that risk mitigation actions are focused on the most significant threats to the business. Finally, the company also offers iSEE^TM, that provides all aspects of 4.0 process development and lifecycle management under one-environment, allowing for models and algorithms to turn data into useful information. “In iSEE^TM, there is the possibility of integration with iRISK Platform, allowing easy access to risk assessments, model plots and visualisation charts through an integrated knowledge base," says José C. Menezes, President and Founder of the company.

In a nutshell, pharma organisations can optimise their QRM process, improve risk-based decisions by comparing risk profiles from multiple strategies, save time building reports, aggregate knowledge across different lifecycle stages, or multiple projects by implementing iRISK^TM. The platform allows a faster time-to-market, reducing the knowledge gaps, and breaking silos.

The effectiveness of the iRISK^TM product portfolio can be best explained with an example. One of 4Tune Engineering’s clients had to choosethe best strategy to be applied after implementing changes in their production process. 4Tune Engineering implemented iRISK^TM to perform an integrated Risk Assessment andused iRISK^TM comparability tool to decide the best strategy to follow. By implementing iRISK^TM, the client was able to digitalise their QRM process, save time, spare efforts, and gain a new risk-based strategy applicable to other unit operations.

With such impressive results, 4Tune Engineering is continuously working towards enhancing its products, keeping the platforms up-to-date according to the clients' feedback and needs. The company strives to reach new markets, such as medical devices and cell and gene therapy, bringing innovation and implementing the current demands from the industry. “Our goal is to improve our presence with a collaborative business model focused on customer success, adopting strategic partnerships. We have strategic partners in the Asian market, U.S., India, LATAM market and we are reaching the global industry with our solutions. This is allowing us to boost the value we provide, support digital transformation for Pharma and Biopharma, and empower our customers with a broader range of paperless solutions and opportunities of higher success,” adds Marcos S. Domingues. In fact, the company’s main goal is to help and support all pharmaceuticals to transform their businesses, creating a new source of value for today’s digital era.