Behind the digital transformation of a vaccine Quality Control lab

A leading global vaccines company launched an initiative to advance its digitally enabled Quality Control laboratory in Belgium. The objective was to upgrade laboratory equipment while ensuring full compliance with 21 CFR Part 11 requirements related to data integrity. ALTEN supported this transformation by contributing to the selection, implementation, and qualification of new laboratory devices within a regulated environment. 

---

The challenge 

The project required upgrading a wide range of laboratory equipment while ensuring compliance with GxP and data integrity regulations. Key challenges included: 

• Ensuring compliance with 21 CFR Part 11 throughout the upgrade process 

• Defining and structuring user requirements for new digital equipment 

• Managing electronic change control assessments 

• Selecting appropriate devices aligned with regulatory and technical specifications 

• Coordinating implementation activities within an active laboratory environments 

The solution

An ALTEN consultant joined the Lab Support Team to provide end-to-end coordination and technical support for the project. The scope of activities included: 

• Project planning and coordination 

• User requirements definition and electronic change control assessments 

• Device selection, qualification, and implementation 

• SAP master data management and SOP updates 

The project relied on standards and tools such as 21 CFR Part 11, GAMP5, LabX (Mettler Toledo), and SAP, ensuring compliance and traceability across all activities. 

---

Results & benefits

ALTEN’s involvement supported the implementation of compliant laboratory equipment within the digital transformation program. The project ensured: 

• Successful upgrade of laboratory equipment within a regulated GxP environment 

• Business continuity maintained throughout implementation activities 

• Compliance with 21 CFR Part 11 requirements, including mitigation actions where required 

• Improved readiness for a digitally enabled Quality Control laboratory 

Key project takeaways 

Digital transformation in laboratory environments must be supported by a structured approach to quality and compliance. Ensuring data integrity, managing change effectively, and maintaining business continuity are critical to successfully implementing new technologies while meeting regulatory expectations. Through its end-to-end support, ALTEN contributed to a compliant and controlled modernisation of the laboratory.