LIFE SCIENCES
How a complex CQV program brought a vaccine facility online
As part of a major investment in vaccine production capabilities, the client launched a new Phase III production building and required a partner to deliver a full set of Commissioning, Qualification, and Validation (CQV) activities. The objective was to ensure the facility could be brought into operation in full compliance with regulatory requirements, particularly Annex 15 of EudraLex. ALTEN was entrusted with the execution and coordination of the validation scope, covering both technical delivery and cross-functional alignment, to support the successful start-up of the new site.
The challenge
The project was characterised by both its scale and its organisational complexity. A total of 122 validation activities and 25 risk assessments had to be executed within the timeline required for the facility’s start-up. The challenge also lays in the diversity of stakeholders involved, including engineering, production, QA, QC, maintenance, and commissioning teams, all of whom needed to be aligned throughout the validation process.
From a project management perspective, several constraints impacted execution:
- The lack of clearly defined deliverables and prerequisites at project initiation, creating uncertainties in planning and execution
- Cost control challenges, directly linked to scope definition and evolving requirements
- The need to harmonise different ways of working, particularly between predefined work packages and more flexible time & material approaches
These elements required strong coordination and structured oversight to ensure progress remained controlled.
The solution
To address these challenges, ALTEN deployed a dedicated team of 11 consultants, operating as a central point of coordination and responsible for managing validation activities. The intervention covered the full validation lifecycle, which included the preparation and execution of Performance Qualification (PQ) activities, from protocol definition to execution of test runs and final reporting. In parallel, the team produced all required technical documentation and risk assessments, ensuring traceability and compliance across the validation process, giving particular attention to deviation management during validation activities.
ALTEN ensured alignment of planning, resources, and execution across all stakeholders, facilitating collaboration between production, QA, QC, engineering, and maintenance teams. The validation scope covered a broad range of systems essential to pharmaceutical manufacturing:
- Utilities, including compressed air, water for injection, pure steam, and process gases
- Cleanroom environments, with activities such as environmental monitoring (Grades C and D), dry fog testing, and thermal mapping
- Process equipment, including autoclaves, washing systems, and decontamination stations
Results & benefits
The structured approach enabled the delivery of the validation program in alignment with project expectations, supporting the start-up of the new production facility. Performance was closely monitored through defined KPIs, demonstrating strong outcomes across all dimensions of the project:
- Budget management
- Scope management
- Planning adherence
- Risk management
- Client satisfaction
- Consultant satisfaction
These results reflect effective coordination, controlled execution, and the successful delivery of a complex CQV scope.
Key project takeaways
The project highlights the importance of strong, centralised coordination in large-scale CQV programs, where multiple stakeholders must be aligned to ensure efficient execution. It also confirms that clear scope definition from the outset is critical for cost control and planning. Through its structured methodologies, KPI-driven governance, and validation expertise, ALTEN demonstrated its ability to manage complex validation environments and deliver end-to-end CQV activities effectively.
