GxP Manufacturing IT Infrastructure Projects
- Multiple European production sites of major pharmaceutical companies
The Challenges
Internal digitization initiatives and external market-driven changes triggered the desire among several clients to migrate existing IT systems from local data centers to modern, scalable cloud environments. Local infrastructure was to be reserved only for particularly critical activities. The challenge was to ensure GxP-compliant processes within a future hybrid infrastructure.
The Solution
We started with a detailed analysis of all production systems regarding operational relevance, technical migration readiness, and regulatory requirements. Based on these insights, we developed tailored migration scenarios, defined target architectures, and planned a step-by-step implementation. A key focus was identifying which systems could be migrated to the cloud both operationally and from a process perspective. Special attention was paid to coordination with local quality organizations: each affected system was reviewed for validation requirements, necessary SOPs and documentation were adapted, and all measures were documented. After successful migration, unused local infrastructure was dismantled, and remaining systems were requalified – all in compliance with regulations.
The Result
The production sites now benefit from a modern, flexible, and audit-proof IT architecture. Non-critical systems were successfully migrated to the cloud without violating regulatory requirements. Operations became more resilient, efficient, and future-proof. Quality units confirmed the compliance of the new structure during audits.
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