CSV strategy & planning
Build validation master plans, gap assessments, and compliance roadmaps. We right-size validation effort using a risk-based approach aligned to regulatory expectations.
CSV for GxP
CSV Services for GxP Companies
We help regulated teams build validation programs that meet GAMP5 and global regulatory expectations. Our services scale from targeted assessments to full end-to-end validation execution.
Full validation execution
End-to-end delivery of URS , FS / DS , IQ/OQ/PQ protocols, execution support, and validation summary reports. We keep documentation inspection-ready.
CSV documentation & templates
Create or refine URS , test scripts, traceability matrices, and SOPs. We provide templates that align to ALCOA+ data integrity expectations.
Training & coaching
Enable internal teams with CSV workshops, validation playbooks, and coaching on risk-based testing and evidence management.
Continuous compliance support
Maintain validated state through change control support, periodic reviews, and re-validation planning for system upgrades.
CSV audits & readiness
Prepare for inspections with mock audits, remediation plans, and targeted assessments for 21 CFR Part 11 and Annex 11 compliance.
Systems we validate
LIMS, CDS, MES, QMS, EDMS, ERP, WMS, temperature monitoring platforms, clinical systems, and safety databases. We tailor validation depth to the system’s GxP impact and intended use.
Talk to a CSV specialist
Let’s scope the right validation strategy for your systems and timelines. We can start with a focused assessment or jump into execution.