About us
Your Trusted Partner in Computer System Validation & Compliance
At 3GxP, we specialize in Computer System Validation (CSV) for life sciences organizations operating in regulated environments. Our mission is to help you implement and maintain compliant, audit-ready systems that meet the highest standards of data integrity, operational excellence, and global regulatory compliance.
With decades of expertise, we support pharma, biotech, medtech, CROs, CDMOs, and research institutions across:
- Manufacturing Execution & Control Systems (MES, SCADA, DCS)
- Clinical Trial Management & eClinical Systems
- LIMS, ELN, and other Laboratory Informatics Platforms
- ERP, QMS, and GxP Infrastructure
- Custom & SaaS-based Digital Platforms
Our validation approach is fully aligned with regulatory frameworks including:
- FDA 21 CFR Part 11 & 820
- EU Annex 11 / EudraLex Volume 4
- MHRA & PIC/S Data Integrity Guidance
- OECD GLP for Computerized Systems
- ICH Q-series & GAMP® 5 methodologies
We ensure your systems are fit for purpose, secure, and inspection-ready—supporting full lifecycle compliance, from planning through operation and revalidation.
Why Choose 3GxP?
- Deep cross-functional GxP knowledge
- Global compliance insight
- Risk-based, cost-effective validation
- Scalable services—from strategic advisory to full execution
- Proven results across FDA, EMA, and MHRA inspections
Partner with 3GxP to build compliant digital foundations that support innovation, scalability, and trust.
Redefining Compliance Through Artificial Intelligence
Automated Risk Assessment
AI evaluates critical systems and recommends validation strategies.
Intelligent Document Review
NLP tools ensure consistency across validation documents.
Continuous Monitoring
Detect anomalies and compliance risks early using AI insights.
Data Integrity Checks
Identify missing audit trails or unauthorized data changes.