Comprehensive Validation Expertise for the Entire Life Sciences Lifecycle.
From manufacturing to the lab bench, we deliver Computer System Validation (CSV) solutions that ensure regulatory compliance, operational excellence, and data integrity.
WHO WE ARE
Your Systems. Validated. Your Compliance. Simplified.
At 3GxP, we understand that every system within your organization — from the shop floor to the clinical data vault — must meet strict GxP and data integrity requirements.
Our Computer System Validation (CSV) services are tailored to the unique needs of life sciences companies, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 frameworks.
We provide end-to-end CSV support — from planning and risk assessment to documentation, testing, and post-validation maintenance — enabling your teams to focus on innovation while we handle compliance.
Our Areas of Expertise
Domain-Specific Validation Across Your Organization
Our validation specialists bring hands-on experience with systems across the entire regulated lifecycle.
Manufacturing Systems
MES, ERP, SCADA, EBR systems.
Clinical Systems
EDC, eTMF, CTMS, IRT, eConsent.
R&D Systems
Discovery platforms, data analytics, and lab automation tools.
Quality Systems
QMS, CAPA, Deviation & Audit systems.
Laboratory Systems
LIMS, ELN, CDS, instrument control software.
Our Validation Services
End-to-End Validation Solutions, Tailored for Regulated Environments
- Service Categories
- CSV Strategy & Planning: Risk-based approaches aligned with GAMP 5 and ALCOA+ principles
- System Assessment: Gap analysis and readiness evaluations
- Validation Documentation: URS, FRS, RTM, IQ/OQ/PQ, and SOPs
- Test Execution & Evidence Management: Controlled, traceable verification of system functions
- Audit & Regulatory Support: Pre-inspection readiness and remediation assistance
- Ongoing Compliance Maintenance: Change control and periodic review programs
WHO WE ARE
A Smart, Risk-Based Validation Framework
Our lifecycle-driven framework combines AI-assisted risk assessment, fit-for-purpose templates, and standardized documentation libraries to streamline validation effort and enhance compliance agility.