Pharma & Life Sciences
GxP-aware QMS, validation and CAPA governance.
Quality assurance for pharma & life sciences projects
In a GxP environment, if it isn't documented it didn't happen — and if the documentation isn't attributable, legible, contemporaneous, original and accurate, it doesn't count either. Our life sciences work focuses on data integrity, validation lifecycle discipline and deviation management that stands up to a regulatory inspection.
Where pharma & life sciences quality typically fails
Hybrid systems are where integrity fails — unsecured spreadsheets, shared logins, audit trails switched off. We assess systems against ALCOA+ and Annex 11 and prioritise remediation by patient and compliance risk.
URS, IQ, OQ, PQ documents that don't trace to each other fail inspection. We verify requirement traceability through the validation lifecycle and check that periodic review is genuinely happening.
An ageing deviation backlog is a standing inspection finding. We triage by risk, rebuild the investigation methodology and put realistic closure governance in place.
What we deliver on pharma & life sciences assignments
- Data integrity assessments against ALCOA+ and Annex 11 / Part 11
- GAMP 5 validation documentation gap review
- Deviation and CAPA system assessment with backlog remediation plan
- Supplier and contract-manufacturer GxP audits
- Inspection readiness reviews and mock audits
Other industries we serve
Oil & Gas
Upstream, midstream and downstream QA, welding and NDE oversight.
Power & Energy
Generation, transmission and renewables quality and commissioning.
Mining & Minerals
Site QA, materials verification and turnover assurance.
Water & Wastewater
Regulated utility assurance and asset-integrity programmes.
Planning pharma & life sciences work in North America?
Send us your scope and applicable standards — we'll respond within one business day.