Computer System Validation Services - Digitally Enabled & Fully Compliant
At Qlairity.ai, we partner with regulated organizations (pharma, biotech, medical devices, CROs) to deliver modern, paperless CSV using the powerful GOVAL® validation platform. Our approach ensures your systems remain audit-ready, GxP-compliant, and highly efficient — all while reducing manual effort and risk.
What We Offer
Transform Validation Through Automation & Risk Intelligence
Traditional, paper-based validation is slow, error-prone, and difficult to maintain.
Automated, compliant validation workflows, guided by GAMP 5 risk-based methodology.
Validation Risk Assessment (VRA): We identify and assess system risk to determine testing scope and depth.
Complete audit trails & traceability: Every action, document change, and signature is recorded.
Continuous validation: Integrate validation into your development lifecycle (e.g., CI/CD), enabling scheduled reviews and regression testing.
AI-enhanced efficiency: Use GoVal AI for intelligent risk assessments, automatic test-case generation, and document creation.
Service Offerings
Full CSV Implementations
Complete validation life-cycle (Planning → URS → FS/DS → IQ/OQ/PQ → Test Execution → Reports)
Validation Master Plans, Traceability Matrices, Protocols, Summary Reports
Risk-Based Validation (GAMP 5)
Apply a risk-based methodology to optimize effort and focus on critical systems.
Align with FDA 21 CFR Part 11 and EU Annex 11 regulations.
Computer Software Assurance (CSA)
Use a more modern, risk-based validation strategy that prioritizes patient safety and critical functions.
Equipment Qualification (IQ / OQ / PQ)
Digitize IQ/OQ/PQ for lab and manufacturing equipment with complete lifecycle management, calibration, and maintenance tracking.
Data Integrity & Compliance
Ensure traceability, audit trails, and secure records to meet ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available).
Maintain electronic signatures, encrypted records, and role-based access.
SOP Development & Change Control
Create or review Validation SOPs, Change Control procedures, and Document Management practices.
Establish electronic workflows for reviews, approvals, and e-signatures.
Audit Readiness & Inspection Support
Provide real-time dashboards, comprehensive audit logs, and “always-audit-ready” documentation.
Support during regulatory inspections with traceability, CAPA documentation, and validated records.
AI-Driven Validation Analytics
Leverage GoVal AI to query your validation data using natural language. Get insights, identify bottlenecks, monitor trends, and optimize your validation process.
Automatically generate risk assessments, validation plans, URS, and test cases reducing cycle time and improving consistency.
Industry-Specific Use Cases
Why Clients Choose Us
Transparent, honest, and partnership-driven
Strong expertise in AI, Automation, Oracle HCM & ERP Cloud
Deep understanding of Middle Eastern business needs
Practical solutions focused on real outcomes
Agile delivery with high accountability
Tailored strategies - not generic implementations
