Genopmobil CSV Solutions

Computer System Validation for Life Sciences

Ensure compliance and data integrity with comprehensive computer system validation services. Our expert consultants help life science organizations validate critical systems according to FDA, EU GMP, and GAMP 5 requirements.

  • FDA 21 CFR Part 11 & EU GMP Annex 11 Compliance
  • GAMP 5 Methodology Implementation
  • Risk-Based Validation Approach
  • Data Integrity Assurance
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Driving Innovation, Empowering Growth

We specialize in Computer System Validation (CSV) for the life sciences industry. With deep expertise in regulatory compliance, our mission is to help pharmaceutical, biotechnology, and medical device organizations ensure that their computerized systems are validated, secure, and audit-ready.

Our team is composed of seasoned CSV consultants, quality assurance professionals, and regulatory specialists who bring decades of hands-on experience with FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5. We combine technical knowledge with a practical, risk-based approach to deliver tailored validation strategies that meet both regulatory expectations and business needs.

We pride ourselves on being more than just a service provider—we’re your compliance partner. Whether you’re launching a new system, undergoing inspection readiness, or strengthening data integrity, we bring clarity, confidence, and compliance to every project.

About Us

Our 5 key phases CSV Service

Comprehensive Computer System Validation Services

Our expert team delivers end-to-end validation services following GAMP 5 methodology and regulatory requirements

Validation Planning & Strategy

  • Validation Master Planning
  • Risk Assessment
  • Requirements Specification
  • Validation Strategy Development

Validation Execution

  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

Compliance & Maintenance

  • Periodic Review
  • Change Management
  • Data Integrity Assessment
  • Compliance Monitoring

Specialized Systems

  • LIMS Validation
  • ERP System Validation
  • CTMS Validation
  • Cloud System Validation

Training & Support

  • CSV Methodology Training
  • Regulatory Requirements
  • Documentation Best Practices
  • Ongoing Support

Audit & Assessment

  • Vendor Audits
  • System Assessment
  • Gap Analysis
  • Remediation Planning
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Help & Guidance

Answers to Common Questions

What is Computer System Validation (CSV) and why is it important?

CSV is the process of documenting that a computer-based system performs as intended and meets regulatory requirements. In life sciences, validated systems ensure data integrity, product quality, and patient safety—while meeting compliance with standards like FDA 21 CFR Part 11 and EU GMP Annex 11.

Which systems need to be validated?

Any system that impacts product quality, patient safety, or data integrity must be validated. This includes manufacturing systems (e.g., MES), laboratory systems (e.g., LIMS), quality systems (e.g., QMS), and ERP systems used in regulated environments.

What is GAMP 5 and how does it support CSV?

GAMP 5 (Good Automated Manufacturing Practice) is a globally recognized guidance that provides a structured framework for validating automated systems. It emphasizes a risk-based approach and scalable lifecycle activities depending on system complexity and impact.

How does your team approach CSV projects?

We use a risk-based, lifecycle approach tailored to your systems and regulatory environment. Our services include planning, risk assessment, validation documentation (URS, IQ/OQ/PQ), testing, training, and inspection readiness—all aligned with GAMP 5 and current regulations.

What is FDA 21 CFR Part 11, and how can I stay compliant?

FDA 21 CFR Part 11 governs the use of electronic records and electronic signatures. Compliance involves system access controls, secure audit trails, validation, and documented procedures. We help you evaluate gaps, implement controls, and ensure full compliance.

Meet Our Team

Experts Driving Your Success

Shahrzad Eghbali

Manager

Behzad Sanie

Manager

Michael Harris

Manager

What Our Clients Say

Real Stories, Real Success

Their team made a complex validation process feel simple. We passed our FDA audit with zero findings.

Quality Director, Biotech Startup

★★★★★

Professional, knowledgeable, and always available. They truly understand life sciences compliance.

CSV Lead, Global Pharma Company

★★★★★

From risk assessments to final reports, everything was handled with precision. Highly recommended.

IT Manager, Medical Device Manufacturer

★★★★★