A leading global vaccine company partnered with ALTEN Technology to enhance their quality management processes. The client sought support in managing critical events and tasks to meet business objectives, as well as assistance in conducting thorough and high-quality investigations. The primary goal of the engagement was for ALTEN Technology to offer comprehensive support, coordination, and expert knowledge to the operational team handling various quality-related functions.

ALTEN Technology’s involvement encompassed several key areas: supporting the overall management of quality tasks, developing and adapting essential help tools, managing delegated CAPA access, and accurately recording mandatory information within SAP. The team also played a crucial role in organizing root cause investigations and impact analyses for deviations stemming from automation issues. Furthermore, ALTEN Technology prepared Phase 0 documentation, followed up on change controls, and coordinated these changes within SAP. Their responsibilities extended to reviewing validation documents, including TCDs, protocols, and reports, while also assisting technical teams in their documentation efforts. A significant part of the project involved diligent tracking of all quality tasks, such as CAPAs, deviations, change controls, self-inspections, and work orders, to ensure timely completion.

Through this partnership, ALTEN Technology delivered significant added value by guaranteeing quality through robust monitoring of the client’s quality systems, demonstrating quick reactivity in tracking quality tasks, and fostering continuous improvement in how quality tasks were managed. The project leveraged expertise in Good Manufacturing Practices and local procedures, utilizing tools like Microsoft Office, SAP, and Techshare, alongside strong relationship skills. This ongoing service contract, based in Wavre, Belgium, has been active since November 2018, with a dedicated team of six full-time employees from ALTEN Technology.