In this article we will discuss the ever growing importance of Quality Risk Management in the context of Lifecycle Management. Risk and knowledge management were introduced by the ICH guidelines (ICH Q8 onwards). Since then, they became increasingly appreciated and implemented through other guidance such as the EU-GMP Guidelines. The forthcoming ICH Read more…
Cytiva and 4Tune Engineering to collaborate in quality risk management for cell therapies Strategic collaboration addresses the need for risk mitigation plans in cellular therapies December 3, 2020 Cytiva, a global life sciences leader, and 4Tune Engineering, a manufacturing-sciences and technology leader, have entered into an agreement to include 4Tune Read more…
WORLD DRUG SAFETY AND EFFICACY: COMBINED EFFORTS TO BETTER SERVE WORLDWIDE PATIENTS Lisbon, Portugal – September 1st, 2020 – 4Tune Engineering and AUSTAR Group have signed a partnership Agreement for the Asian Market to serve customers with a long-term stability, supporting Companies in their 4.0 digital transformation. 4Tune Engineering is known in the Life Read more…
CEO’s STATEMENT I am particularly delighted and honoured to be appointed 4Tune Engineering’s (4TE) CEO. Marcos S. Domingues, Chief Executive Officer at 4Tune Engineering Joining the company in August 2016, I soon realized that this was a different company. Built under Prof. José C. Menezes vision, this company had a Read more…
With a focus on Patient & Product: Excellence over Lifecycle Lisbon, Portugal – July 13, 2020 – 4Tune Engineering and PGI Pharma have signed a partnership to Agreement in a position to better serve customers in order to provide to leading biopharma companies state-of-the-art Manufacturing Sciences & Technologies solutions, based on advanced analytics Read more…
“We are facing difficult times of uncertainty, but one thing we know: we will work harder than ever to overcome this outbreak together”. And that is the message of our President & Founder, José Cardoso de Menezes read more…
After two years awarded as SME Leader, for the first time, 4Tune Engineering has been awarded the ranking of SME EXCELLENCE. The SME Excellence status is a corporate reputation label granted to distinguish the merit of national SMEs (Small and Medium-sized Enterprises) with superior performance and is awarded after the evaluation Read more…
“After a careful evaluation, we found iRISKTM to be suited to our R&D business operations and may further manage our complete lifecycle. Together with 4Tune Engineering’s support, I am confident that we will make QRM aligned with our Business Process Excellence aspirations.” Vicky Pirzas, Senior Director of Recombinant Product Development at CSL Read more…
‘The software allows the Quality representative to check on processes, incoming raw materials, finished product analyses, and any other items necessary.’ The article on Contract PHARMA magazine highlights iRISK™ as a solution to enhance communication within a corporation.’ READ MORE
“We believe that this joint offer to the market will give our customers a one-stop-shop for all needs for CQV (commissioning qualification validation) throughout the Process Product lifecycle. By aligning software and services, we are confident that the industry will be empowered to tackle future regulatory and business challenges.” – Read more…