SAP S/4HANA case study
SAP S/4HANA builds compliance into every pharmaceutical batch
A pharmaceutical manufacturer kept batch, quality and serialization data in different systems. SAP S/4HANA now holds them with production.
- MinutesRecall trace, down from daysNot stated in source · Delivery report
- 100%Batch genealogyNot stated in source · Delivery report
- ZeroTraceability findings at auditNot stated in source · Delivery report
- 18 wkFrom kickoff to liveProject duration · Delivery report
The challenge
Compliance records spread across systems
Batch records, quality results and serialization data lived in different systems and spreadsheets.When a supplier lot was questioned, staff spent days matching it to finished product, and audit preparation pulled the team off the line.
- Tracing a raw material lot to finished product took days.
- Quality results were recorded separately from production.
- Serialization data did not line up cleanly with batch records.
- Audit prep was manual and consumed the quality team for weeks.
The solution
Genealogy and quality inside the process
We set up SAP S/4HANA with process manufacturing, quality management and batch genealogy, so every batch carries its full history and quality gates sit inside the production flow.Serialization links to the same records.
- Each finished batch links back to every raw material lot used.
- Quality inspections are steps in the process, not a side log.
- Serialization ties to batch records for end-to-end tracking.
- A full upstream and downstream trace runs in minutes.
How we delivered
Validated against the compliance standard
We configured the batch and quality setup around the firm's regulatory standard and ran a documented validation, so the records the system keeps are the records auditors expect.Operators record results as they work, which keeps data accurate.
Go-live took eighteen weeks, including validation and a practice recall trace.
The outcome
Recalls in minutes and audits without the scramble
A trace that took days now runs in minutes, and every batch carries full genealogy.Quality results sit with production, so the last audit closed with no traceability findings and the team prepped without leaving the line.
When a lot is questioned, we trace it end to end while the caller waits. Quality lives inside production now, so audit week feels routine instead of frantic. Quality Head, Pharmaceuticals
Related service
ERPRelated
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