The CSV Challenge in Pharma Manufacturing
Computer System Validation for pharma manufacturing is essential for ensuring regulatory compliance, data integrity, and operational continuity. Pharmaceutical manufacturers rely on validated systems such as MES, LIMS, ERP, SCADA, and PLC to meet GxP standards and maintain audit readiness.
When one client needed to validate all these systems before production began, they turned to SEQOVA. Our role was to deliver a full-scope Computer System Validation program that aligned with regulatory standards, mitigated risks, and supported a smooth go-live.
What We Did
SEQOVA collaborated closely with the client’s internal stakeholders and system integrators to implement a risk-based CSV strategy aligned with EU Annex 11 and GAMP 5 principles.
IT Architecture and Core Services
- We validated critical infrastructure components including servers, Active Directory, backup and restore processes, time synchronization, and antivirus systems. These validations ensured system reliability and alignment with EU Annex 11 requirements for IT infrastructure.
IS Software Validation (MES, LIMS, ERP)
- Following a GAMP 5-compliant approach, we developed and executed a full validation package from User Requirements Specification (URS) to Performance Qualification (PQ). This included validating audit trails, access controls, electronic signatures, and data workflows across key systems supporting manufacturing and lab operations.
Operational Controls
- We established lifecycle management controls including Standard Operating Procedures (SOPs), change control processes, system inventory tracking, and compliance governance protocols to support ongoing audit readiness.
All validation documentation was prepared, executed, and approved in accordance with regulatory expectations on time and without major deviations.
Why Computer System Validation Matters in Pharma Manufacturing
Validation is not just a requirement. It is a foundation for secure, compliant, and efficient operations. SEQOVA’s approach to Computer System Validation for pharma manufacturing ensured that critical systems were reliable, compliant, and ready to scale with the business.
This case study demonstrates our ability to translate regulatory expectations into executable plans that work in real-world conditions bridging the gap between facility setup and long-term digital compliance.
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