Sector engineering
Pharmaceutical
GxP-aligned platforms across discovery, clinical validation, and manufacturing supply integrity — engineered for regulator-grade evidence by construction.
- GxP
- 21 CFR Part 11
- GAMP 5
02 — Engineering practice
How we engineer for this sector.
Pharmaceutical systems live under continuous regulatory scrutiny. Discovery, clinical trials, manufacturing, and distribution each carry distinct evidentiary obligations — and the platforms that span them must be engineered against those obligations, not retrofitted after the fact.
Our practice spans LIMS, ELN, CTMS, MES, and serialization platforms — engineered against GAMP 5 categorization, validated under IQ/OQ/PQ, and operated with the audit trail that 21 CFR Part 11 and MHRA (Medicines and Healthcare products Regulatory Agency) GxP expectations demand; patient and trial-participant personal data is processed in accordance with the UK GDPR. Electronic signature, change control, and impact assessment are first-class engineering concerns, not paperwork.
Supply integrity is the discipline that compounds. We engineer serialization, track-and-trace, and supply-chain visibility into the operational fabric so the platform proves provenance on demand — across batches, sites, and jurisdictions.
03 — Engineering surface
The technologies behind this sector practice.
A selection of the platforms, standards, and tools our principals engineer with in this sector.
Quality & Compliance
- GAMP 5
- 21 CFR Part 11
- MHRA GxP
- UK GDPR
- ISO 13485
- GxP / IQ-OQ-PQ
Platforms
- Veeva Vault
- LabWare LIMS
- STARLIMS
- Werum PAS-X
- Tulip MES
Serialization & Supply
- GS1 standards
- EPCIS
- Track-and-trace integration
- Cold-chain telemetry
- IoT gateways
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