Quality Track Highlights from 2020 Veeva R&D Summit Europe
It’s evident from the 2020 virtual Europe R&D and Quality Summit that consolidating systems and harmonizing quality processes has become a top priority for the life sciences industry. All four customer presentations in the quality track highlighted the benefits of unifying quality processes across functions.
In his keynote, Unifying and Connecting Quality, Kasper Ingmann Bille Fynbo, senior director of quality systems at LEO Pharma, shared how a unified approach drove continuous quality improvements throughout the product life cycle. LEO Pharma’s modernization journey began with standardizing different quality processes on a single platform. “Our primary goal was to build a data foundation that can support growth initiatives, increase operational efficiency, and provide business intelligence,” said Kasper. “And we achieved it with a global system that unified and connected our quality events.”
In her presentation on transforming quality management, Lélia Martinescu, QA GxP systems head at Idorsia, discussed a similar approach to streamlining GxP processes. As a young company, Idorsia wanted to establish simple, best-in-class quality processes to support their business today and after the commercial phase. They streamlined quality across clinical (GCP), manufacturing (GMP), and other GxP areas with Vault QMS.
Both Kasper and Lélia emphasized the importance of having robust processes in place before implementing a new system. They recommended kicking-off the transformation project by gathering essential requirements from all stakeholders and simplifying existing processes.
Merck KGaA, Darmstadt, Germany, discussed their journey and lessons learned in implementing a modern solution that streamlined quality and risk management, provided consolidated real-time reports, and ensured compliance with data privacy standards. “Implementing quality and risk management, two distinct processes, in a single tool is the best way to achieve true data integration and transparency,” said Nuno Galante Valério, associate director, quality compliance lead at Merck KGaA, Darmstadt, Germany. A single source of truth enabled Nuno’s team to understand issues and their connection to risks, standardize their risk scoring and tolerance, and proactively handle critical issues and mitigation actions. View Nuno’s presentation on unifying quality and risk management here.
Similarly, in their presentation on improving GxP training, Alvotech discussed the efficiency and effectiveness of creating documents, delivering training, and tracking progress in the same workflow. Alvotech’s legacy training system lacked automation and caused many inefficiencies. For example, every time a new version of an SOP was approved, their training team had to manually cancel any related open training assignments. By unifying training and document management, Alvotech automated manual processes and reduced the operational cost of complex cross-application integrations. View Alvotech’s presentation here.
To watch these and other sessions from R&D Summit on-demand through June 17, click here.
Continue the learning at Veeva R&D Summit, NA, a virtual event on October 13-14, to hear how more companies are harmonizing quality processes. Register here.