Reducing compliance risk through a strategic SAP upgrade

End-of-support risk in a GxP SAP landscape

A global pharmaceutical Contract Development and Manufacturing Organization (CDMO) was operating SAP S/4HANA Release 2021 SP02, which was approaching the end of SAP’s mainstream maintenance period. Remaining on the existing release would increase the risk of losing access to SAP standard support and critical security updates, while exposing the organization to greater operational and compliance risks.

Operating in a highly regulated environment, the organization also needed to ensure that the upgrade protected system and data integrity while meeting GMP requirements. A successful release upgrade therefore required a structured, risk-based approach that balanced regulatory expectations with business continuity.

A risk-aware SAP S/4HANA technical release upgrade

The organization upgraded its SAP S/4HANA landscape from Release 2021 SP02 to Release 2023 SPS04, ensuring continued access to SAP mainstream maintenance and providing a stable foundation for future business initiatives.

The release upgrade minimized technical and operational risk while preserving existing business functionality throughout the transition. By applying a risk-based validation strategy and maintaining a strong focus on compliance, the upgrade reduced enterprise and cybersecurity risks, supported regulatory requirements, and accelerated time-to-value without disrupting business operations.

Risk-based validation and project quality support

NNIT helped the client turn compliance into a project enabler. By providing expert Computer System Validation (CSV) advisory and consulting services throughout the implementation, NNIT helped shape and support a pragmatic, risk-based validation strategy that met regulatory expectations without slowing down delivery.

NNIT focused validation efforts where they mattered most  on critical business processes, GMP-related impact, data integrity, SAP security, access control, and overall compliance risk. This ensured that the client had the right level of assurance, documentation, testing, and traceability to support both go-live readiness and long-term inspection confidence.

In parallel, NNIT delivered Project Quality Management (PQM) services to keep quality embedded in the project from start to finish. NNIT supported key validation deliverables, guided project teams on compliance expectations, identified and addressed quality risks, and helped ensure that validation evidence was complete, consistent, and audit-ready.

With NNIT’s combined CSV and PQM expertise, the client was able to maintain project momentum, reduce compliance uncertainty, and achieve a successful, on-schedule go-live.