Computer System Validation for UAE & GCC
Accelerate compliance with modern GAMP 5 and Computer Software Assurance (CSA) methodologies. FDA 21 CFR Part 11 and EU GMP Annex 11 aligned validation that reduces time-to-compliance by 40-60%.
20+
Years Experience
100%
Audit Success Rate
40-60%
Faster with CSA
GAMP 5
Risk-Based Approach
Comprehensive CSV Services
End-to-end validation support using modern risk-based methodologies for pharmaceutical, biotech, and medical device companies across the UAE and GCC.
Validation Lifecycle Management
Complete validation from Validation Master Plans (VMP) and User Requirements Specifications (URS) through IQ/OQ/PQ execution to ongoing periodic reviews.
Risk-Based Validation (GAMP 5 & CSA)
Modern Computer Software Assurance (CSA) and GAMP 5 aligned approaches that reduce validation time by 40-60% while maintaining compliance.
Cloud & SaaS Validation
Specialized validation for AWS, Azure, and cloud-hosted platforms including hosted ERP, eQMS, and laboratory systems.
System-Specific Validation
Expert validation for ERP, MES, LIMS, eQMS, chromatography data systems (CDS), and laboratory/process control systems.
IQ/OQ/PQ Protocol Execution
Protocol development and execution with comprehensive, inspection-ready evidence packages and traceability matrices.
Legacy System Remediation
Gap analysis and remediation for existing systems to meet current FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.
Audit & Inspection Readiness
Mock inspections, gap assessments, and remediation projects to ensure your systems are inspection-ready at all times.
Periodic Review & Maintenance
Ongoing validation maintenance, change control support, and periodic review execution to sustain compliance.
The CSV Lifecycle: Our Proven Methodology
We follow a structured, GAMP 5-aligned approach that covers every phase of your computerized system's lifecycle—from initial planning through ongoing maintenance.
Planning & Requirements
We develop a comprehensive Validation Master Plan (VMP) and gather User Requirements Specifications (URS) to establish the foundation for your validation project. This phase includes risk assessment using GAMP 5 software categorization to determine the appropriate level of validation effort.
Design & Specification
Our team creates detailed Functional Specifications (FS) and Design Specifications (DS) that trace directly to your requirements. We establish a Requirements Traceability Matrix (RTM) to ensure complete coverage throughout the validation lifecycle.
Installation Qualification (IQ)
We verify that the system is installed correctly according to manufacturer specifications and design documentation. IQ includes verification of hardware, software, network configurations, and environmental conditions.
Operational Qualification (OQ)
Testing the system under normal operating conditions to verify it performs as specified. OQ covers all functional requirements, user access controls, data integrity features, and interface testing with connected systems.
Performance Qualification (PQ)
Final validation phase demonstrating the system consistently performs as intended in your production environment. PQ uses real-world scenarios and production data to confirm operational readiness.
Ongoing Maintenance & Periodic Review
Validation doesn't end at go-live. We support change control processes, incident management, and conduct periodic reviews to maintain the validated state throughout the system lifecycle.
Systems We Validate
Expert validation for all GxP-regulated computerized systems across the pharmaceutical and life sciences industry
Why Choose Neural Architects for CSV in UAE?
With 20+ years of pharmaceutical validation experience across global operations, we bring proven expertise in both traditional CSV and modern Computer Software Assurance (CSA) methodologies.
Our risk-based approach reduces validation effort by 40-60% compared to traditional methods—without compromising compliance. We deliver inspection-ready documentation that gives you peace of mind for FDA, MHRA, and regional audits.
As specialists in the UAE and GCC market, we understand both international regulatory expectations and local business requirements. Whether you're a multinational pharmaceutical company expanding into the region or a local manufacturer preparing for export, we tailor our approach to your specific needs.
Regulatory Frameworks We Support:
FDA 21 CFR Part 11 • EU GMP Annex 11 • GAMP 5 • ICH Q9 • ALCOA+ • PIC/S • WHO Guidelines
Frequently Asked Questions
Common questions about Computer System Validation for pharmaceutical and life sciences companies
What is Computer System Validation?
Computer System Validation (CSV) is a documented process that establishes evidence providing a high degree of assurance that a computerized system will consistently produce results meeting predetermined specifications and quality attributes. For pharmaceutical, biotech, and medical device companies, CSV is not optional—it's a regulatory requirement enforced by the FDA, EMA, MHRA, and health authorities worldwide.
In the UAE and GCC region, pharmaceutical companies must demonstrate that their computerized systems—from laboratory instruments to enterprise software—are fit for their intended purpose and maintain data integrity throughout the product lifecycle. This includes systems used in manufacturing, quality control, clinical trials, regulatory submissions, and distribution.
Effective CSV follows a risk-based approach aligned with GAMP 5 (Good Automated Manufacturing Practice) guidelines, focusing validation effort where it matters most: patient safety and data integrity. Modern approaches like Computer Software Assurance (CSA) further optimize this process, reducing documentation burden while maintaining—or even improving—compliance outcomes.
Ready to Achieve Compliance Excellence?
Whether you're facing an audit, implementing new systems, or building AI solutions for regulated environments—we're here to help.
Free initial consultation • No obligation • UAE & GCC focused