SAP S/4HANA validation for a mid-market oral-solid-dose manufacturer — inspection-ready in 12 weeks

Pain points before the engagement

• Every SAP release had turned into a multi-month validation project — even for small QM configuration changes
• Scripted tests defaulted for every requirement, inflating effort and slowing every go-live
• Traceability lived in spreadsheets that went stale between drafts, drafts and inspection prep
• Two previous audits had surfaced findings on data-integrity around movement types
• No consistent risk model across the three sites — practice varied by validation lead

Problem

This manufacturer had grown from one manufacturing site to three in five years. The validation practice had grown organically alongside — but not modernised. Every SAP release, even a minor QM tweak, kicked off a validation project that consumed months of effort. Meanwhile the FDA's CSA direction was signalling that this maximalist approach was neither required nor defensible. They needed to re-baseline the validation practice, cut the effort on low-value scripted testing, and stand up a consistent risk-based operating model — before their next scheduled inspection window closed.

Approach

We ran a CSA re-baseline focused on the SAP GxP scope: every requirement scored against ICH Q9 for severity, probability and detectability. Scripted tests reserved for critical requirements; exploratory testing for medium risk; vendor-evidence leveraged for non-configured standard modules. GxP Copilot generated the deliverable set, kept the traceability view live, and gave inspectors a single evidence pack per module. A parallel workstream harmonised the risk model across all three sites so future releases run the same playbook.