Case Study: a leading pharmaceutical group achieves compliant global facility and asset management digitalisation with Expleo

Computerised system validation for facility and asset management digitalisation program

Expleo was engaged by a leading pharmaceutical group to address the challenge of validating and ensuring the global compliance of its new facility and asset management IT systems. The client needed to standardize business processes and data across approximately 20 worldwide sites, migrating from local systems to a single global ERP while adhering to strict health authority regulations from the FDA and other bodies. The key challenge was to implement consistent standards, avoid audit failures, and raise awareness of the regulated environment across all project teams.

The solution from Expleo involved providing validation lead experts and a full array of services, including computerised system validation (CSV), test coordination, data migration, and the creation of risk assessments and compliant documentation. Expleo's team worked integrated within the client's teams to ensure the systems were validated on time and on budget. The results included the successful digitalization of processes, a reduction in paper-based workflows, and the assurance of no audit findings during inspections across the global sites.