Oracle ERP for Pharma & Life Sciences.
Validated Oracle ERP for pharma and life sciences — GxP, serialisation, batch records, and regulatory reporting.
Validated Oracle for pharma and life sciences.
We deliver validated Oracle ERP environments for pharma and life sciences — with GxP-aligned methodology, serialisation, batch records, and full regulatory audit trails.
- GxP-aligned implementation and validation methodology
- Serialisation and DSCSA / EU FMD compliance
- Batch records and electronic signatures (21 CFR Part 11)
- Regulatory reporting and audit trail management
What we cover for pharma.
GxP & validation
URS, IQ, OQ, PQ, validation playbook, change control.
Serialisation
DSCSA, EU FMD, parent-child packaging, traceability.
Batch records
Electronic batch records, deviations, exceptions, sign-off.
21 CFR Part 11
Electronic signatures, audit trail, access control.
Quality & QC
Sampling, COA, stability testing, hold/release workflows.
Regulatory
FDA, EMA, MHRA reporting and audit trail.
How we deliver validated Oracle.
Assess
GxP scope, regulatory exposure, current validation pain.
Design
URS, validation plan, change control, training plan.
Build
Configure Oracle, build extensions, integrate QC and serialisation.
Validate
IQ, OQ, PQ with full evidence and sign-off.
Run
Hypercare, change control, periodic review, audit support.
Why pharma and life sciences pick ETHX.
GxP-aligned methodology with validation evidence built in
DSCSA and EU FMD serialisation experience
21 CFR Part 11 e-signature and audit trail expertise
Validated change control across releases
Audit support — we've stood next to clients in regulator visits
Tight Quality + Manufacturing + SCM integration
Close consolidation cut from 10 to 6 days with full audit trail
FCCS rollout across 14 legal entities with ARCS-automated reconciliations and validated change control.
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Pharma & Life Sciences — frequently asked questions
Run validated Oracle ERP for pharma.
Book an assessment — we'll review your validation and serialisation exposure.