Who We Are
Computer System Validation Experts for Regulated Industries
We specialize in delivering comprehensive Computer System Validation (CSV) consulting & services that ensure computerized systems used in regulated industries are fit for their intended use, accurate, reliable, and compliant with regulatory requirements.
Our Expertise
Deep regulatory knowledge across global standards
With deep expertise in FDA, EMA, GxP, and industry best-practice standards, our team partners with clients to validate systems efficiently, transparently, and with quality at the forefront.
FDA
21 CFR PART 11 compliance
EMA
EU ANNEX 11 standards
GxP
GMP, GLP, GCP guidelines
ICH
Q7, Q9, Q10 standards
Plus industry best-practice standards
Industries We Serve
Trusted by regulated industries worldwide
Pharmaceuticals
Medical Devices
Biotech
Healthcare
Food & Beverage
Sometimes
Our Services
Full validation lifecycle support
We support organizations across the full validation lifecycle—including risk assessments, validation planning, requirements development, testing, documentation, and continuous compliance.
🔍
Risk Assessments
📋
Validation Planning
✍️
Requirements Development
🧪
Testing & Execution
📄
Documentation
✅
Continuous Compliance
When You Need Us
New System Implementation
Validating systems from the ground up
System Upgrades
Upgrading existing technology safely
Audit Preparation
Preparing for regulatory inspections
Our Mission
Building confidence in your technology
Driven by a commitment to accuracy, integrity, and operational excellence, our mission is to empower our clients with compliant, secure, and high-performing systems that stand up to regulatory scrutiny.
We don't just validate systems—we build confidence in your technology.
Accuracy
Precision in every validation step
Integrity
Uncompromising ethical standards
Excellence
Operational excellence in delivery
Ready to validate your systems?
Whether you are implementing a new system, upgrading existing technology, or preparing for an audit, we provide the knowledge, structure, and hands-on support to help you succeed.