Batch genealogy
End-to-end traceability from raw-material lot through finished product serial, assembled in a hurry at audit time instead of being queryable on demand.
Life sciences
Validated systems, batch genealogy, audit-ready evidence
SAP for pharmaceutical, biotech and medical-device manufacturers — where every batch has to tell its own story, every system has to be validated, and every signature has to be electronic.
What we see in this sector
Sector-specificpressures
Validated systems (GxP)
Change-control overheads so heavy that routine updates get delayed or batched into risky large releases.
Serialisation at scale
DSCSA, EU FMD, and country-specific serialisation regimes requiring per-unit identifiers to flow through SAP, line systems and partner EPCIS layers consistently.
Supply chain integrity
Cold-chain, counterfeit and diversion risks that need to be monitored across a long and increasingly outsourced supply network.
The validation calculus
Validation is not a tax — it’s the reason your systems can be trusted to be medicines, devices and therapies. But validation done badly becomes a tax: slow releases, big-bang changes, patch-cycle lag.
Validation done well is just discipline — small, documented changes, repeatable test evidence, approval workflows that are quick because the artefacts are already there. That’s the model we bring.
Frequently asked
Common questions fromlife sciences leaders
Do you deliver GxP-validated SAP implementations?
Yes. Every engagement includes the validation package — URS, FS, DS, IQ/OQ/PQ, traceability matrices and risk assessments — authored alongside the build, not bolted on at UAT. Change control runs against 21 CFR Part 11 and EU Annex 11.
How do you handle pharmaceutical serialisation?
SAP Advanced Track and Trace for Pharmaceuticals (ATTP) for the central layer, with line-system integration via SAP Plant Connectivity or direct EPCIS where the line already speaks it. Country compliance packs for DSCSA (US), EU FMD, Russia Chestny ZNAK and Saudi Arabia DRUGS.
Can you deliver batch genealogy on S/4HANA?
Yes — using S/4HANA Batch Management combined with Discrete Industries + Process Industries (DIMP) configuration for pharma. End-to-end traceability from raw material through to finished serial is queryable from the running system rather than reassembled at audit time.
Do you support cold-chain monitoring?
Yes. SAP Advanced Track and Trace plus temperature-sensor telemetry via SAP Event Mesh into HANA, with excursion alerting and audit-ready evidence packs. Pattern works across in-transit and warehouse.
Next step
Working in life sciences? Let's compare notes.
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